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Voyager is looking for exceptional individuals who share our passion for developing life-changing gene therapies for severe neurological diseases.

Current Openings

Associate Director/Director, Regulatory Affairs

The Company

Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

 The Position

This position will report to the Vice President of Regulatory Affairs. As the Associate Director/Director of Regulatory Affairs, you will be responsible for development and implementation of regulatory strategy for assigned projects, serving as the regulatory lead on project teams, and serving as the regulatory contact with regulatory authorities.

Responsibilities:

  • Serve as the regulatory lead on project teams with expertise in U.S. and EU regulatory affairs
  • Develop and implement regulatory strategy for assigned projects in all stages of development (pre-IND/pre-CTA through approval and life-cycle management)
  • Project manage regulatory deliverables coordinating all aspects of regulatory submissions for assigned projects
  • Author regulatory documents in support of filings including INDs/CTAs, Briefing Materials, and BLAs/MAAs
  • Work collaboratively on cross-functional teams taking a problem-solving approach
  • Identify regulatory risks and provide proposals for risk mitigations
  • Prepare and deliver effective presentations for external and internal audiences
  • Lead interactions with regulatory agencies
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
  • Mentor other Regulatory staff members

Qualifications

  • A minimum of a Bachelor’s degree required
  • Advanced scientific degree preferred (i.e. MS, PharmD, PhD, etc.)
  • A minimum of 8 years of pharmaceutical/biotechnology industry experience and 5 years in regulatory affairs
  • Experience working on products in development specifically relating to clinical and nonclinical regulatory aspects of the project
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Knowledge of GCPs and GLPs
  • Excellent communication (written and verbal) and influencing skills
  • Strong organizational skills, including the ability to prioritize workload
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively, Specifically, an ability to provide viable approaches to problem-solving based upon an ability to interpret current Regulations and Guidances for unique applications for innovative gene therapy products
To apply, email careers@voyagertherapeutics.com

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Voyager Therapeutics is developing life-changing gene therapies for fatal and debilitating diseases of the central nervous system. Our founders include scientific and clinical leaders in the fields of adeno-associated virus (AAV) gene therapy, expressed RNA interference and neuroscience. Our management team has deep expertise and a track record of building exceptional life science companies.

The Talent Coordinator will be a member of Voyager’s Human Resources team and will be responsible for the recruiting coordination for all roles across Voyager Therapeutics. The Talent Coordinator will orchestrate all stages of a candidate’s journey, ensuring a positive experience for the candidate while communicating closely with hiring managers and the Human Resources team throughout the process.  The coordinator will also work with Voyager employees to assist with onboarding, set up of benefits and employee data, and help communicate Voyager programs, benefits and initiatives.   The ideal coordinator is personable, extremely organized, keeps calm under pressure, and thrives in a fast-paced environment. This role provides the right candidate with the opportunity to take on substantial ownership within Voyager’s Recruiting and HR functions.

Key Responsibilities

  • Orchestrate movement of all candidates through the recruiting process, with a focus on scheduling interviews, tracking progress, and coordinating interview/travel logistics
  • Serve as the primary candidate touchpoint throughout the recruiting process, leveraging excellent communication skills and customer-service mentality to ensure a positive candidate experience
  • Coordinate with all levels of management and the respective administrative team(s) to provide white-glove service for candidates
  • Proactive approach to candidate development, including creating and sending interview itineraries, company information, and providing updates on timelines and next steps in process
  • Support onboarding efforts by assisting the team with offer letter generation, initiating background screenings, verifying I9s and maintaining employee personnel files.
  • Keep recruiters and hiring managers informed on feedback and next steps
  • Interact with agencies and vendors, setting expectations and keeping them updated on process
  • Partner with Talent Acquisition and HR team to track updates on all candidates, provide leverage on searches, and assist with gathering information on onboarding new employees
  • Coordinate administration of employee benefits changes, including enrollments, terminations and provide general benefits support to employees as needed.
  • Partner with HR Operations team to insure employee onboarding is complete, and new employees are introduced to Voyager programs and benefits.
  • Work on communications and interactions to support a variety of employee changes including role changes and promotions.
  • Maintain HR team group calendars and meeting schedules.
  • Contribute to a range of HR initiative including new hire welcomes, learning programs, communications initiatives, outings and events.
  • Provide back-up support/coverage for reception desk or other team members as needed.

Skills & Qualifications

  • Excellent interpersonal and written and verbal communication skills
  • Strong organizational skills and ability to multitask
  • Able to quickly gain employee trust and handle confidential candidate and employee information
  • Must work well under pressure and be able to problem-solve in a fast-paced environment
  • Able to speak comfortably with employees and candidates of all levels
  • Able to read situations quickly and facilitate cooperation

Requirements

  • A minimum of a Bachelor’s degree is required
  • A minimum of 1 year of co-op and/or professional work experience, ideally in recruiting coordination, Human Resources administration, or similar function
  • Interest in a career in Recruiting/Human Resources
  • Advanced computer skills in MS Office Suite and related applications a must
  • Experience with Applicant Tracking Systems (ATS) highly preferred
  • Experience with HR database or similar systems strongly preferred
To apply, email careers@voyagertherapeutics.com

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 Manager, Lab Operations

 Voyager Therapeutics is a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the central nervous system. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. The company’s pipeline is focused on severe CNS diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease and spinal muscular atrophy (SMA). Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School. Our founders include scientific and clinical leaders in the fields of adeno-associated virus (AAV) gene therapy, expressed RNA interference and neuroscience. Our management team has deep expertise and a track record of building exceptional life science companies.

 Voyager is seeking a highly motivated and experienced Manager, Lab Operations to provide support functions to ensure a smooth progression of our research programs and scientific staff at multiple locations in Cambridge. The primary responsibilities require a high level of customer service, while delivering strategic and tactical execution of lab operations. The ideal candidate will be responsible for, but not limited to scientific staff support, purchasing & inventory management, equipment/maintenance, metrology and vendor management. The successful candidate will embrace change, innovation and initiate process improvements by creating sustainable, value – add propositions.

Responsibilities: 

  • Demonstrated experience establishing/negotiating and managing/supervising effective relationships with range of external vendors and service providers, including on-site contract personnel
  • Manage/oversee the maintenance and repair of laboratory equipment, including daily upkeep, routine quality control and troubleshooting, and scheduling of preventive maintenance
  • Serve as the primary contact for equipment maintenance/repair and all purchasing activities for Capital expenses, consumable orders and ample stock of lab reagents
  • Identify and implement continuous improvement projects.
  • Partner with EHS to ensure safe working environment for all scientific staff
  • Develop and maintain accurate and user-friendly inventory management program
  • Work with Finance to track and manage capital assets
  • Assist internal and external audits and inspections
  • Lead management of alarm systems, including restoration and routine checks
  • Manage storage and pick up for all lab waste
  • Establish and document industry best practices, negotiate schedules and contracts to maximize efficiencies
  • Coordinate daily/weekly shipping/receiving activities to include BL2 samples
  • Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results

Requirements: 

  • Bachelor’s degree highly preferred
  • A minimum of 5 – 8 years of experience either in an academic or industry setting; or equivalent combination of education, training and experience
  • Experience interacting with various regulatory agencies
  • Proficiency with computer-based data management and Microsoft Office is required. Knowledge of LIMS, CMMS, BioProcure, Oracle systems a plus
  • IATA Shipping Certifications and/or Wastewater Treatment Grade 2 license a plus

Additional Skills:

  • Outstanding customer service and attention to detail is required
  • Ability to see tasks through to completion, deliver successful results, and instill confidence across the organization is vital
  • Excellent organization, written and verbal communication skills
  • Ability to work well within a fast-paced environment across multi-disciplinary teams
  • Strong multi-tasking and sound time management skills
  • Live Voyager’s core values of Passion, Pioneering, Integrity and Collaboration in every aspect of his/her work life
To apply, email careers@voyagertherapeutics.com

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Senior Scientist/Engineer – Upstream Process Development

Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

Voyager Therapeutics is developing recombinant adeno-associated virus (rAAV) vectors for treating neurological diseases. Developing robust and reliable vector production processes is central for establishing successful gene therapy applications.  Voyager is seeking a highly motivated Senior Scientist and/or Engineer to join the Upstream Process Development Group.  The qualified candidate will be a leader within the group with a strong background and expertise in cell culture manufacturing of biologics.  Primary responsibilities will include carrying out upstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products, participating in and leading internal productions, writing appropriate documents and carrying out technology transfer to assorted CMOs, and finally participating in cGMP manufacture person in plant activities.  The ability to independently organize and design experiments, analyze data and report the results of their and other’s work in a concise and well documented manner, and to take the initiative to successfully drive Voyager’s projects and manufacturing process are all important aspects of the position.  

Responsibilities

  • Design, development, and optimization of cell growth, transfection, viral infection, and rAAV manufacturing using shake flasks, small-scale and large-scale bioreactors in an Sf9 / baculovirus production system
  • Assemble, sterilize, prepare, and maintain bioreactors, ancillary materials and equipment for cell culture, viral infection and harvest experiments
  • Perform monitoring of cell viability and growth, cell culture metabolites, and other measurements from cultures
  • Develop protocols for viral genome / capsid production in shake flasks, wave bioreactors and stirred tank bioreactors
  • Generate, manage, and maintain critical methods and data in a highly organized manner
  • Assist with and lead the production of nonclinical materials at Voyager
  • Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents
  • Provide support for and lead the transfer of developed protocols and upstream processes to internal and external manufacturing parties
  • Lead innovation, development and optimization of the Voyager upstream platform manufacturing process
  • Be the Voyager point person for and maintain various external relationships with partners, vendors and CMOs/CROs
  • Be highly involved with and help lead the Process Development group’s IP, conference and publication strategy

Qualifications

  • Degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, or related fields
  • PhD degree in relevant subject matter (e.g. cell culture production of biologics) with 5+ years industrial experience in process development
  • Previous experience working with protein biologics or vaccines is a must, prior experience working with rAAV products desired
  • Proficient with aseptic techniques and the use of shake flasks, wave based bioreactors, and stirred tank bioreactors at various scales
  • Strong desire to learn multiple new techniques and willingness to work as part of and help lead a larger team
  • Significant attention to detail and accuracy in developing, reviewing and following protocols, SOPs, batch records and technology transfer documents
  • Ability to be highly productive in a fluid, fast-paced and teamwork oriented environment
  • Prior experience with tech transferring to a cGMP facility is a must, prior experience working with external CMOs desired
  • Prior experience managing a team, co-ops or direct reports is desired
To apply, email careers@voyagertherapeutics.com

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Senior Associate Scientist / Engineer – Upstream Process Development

Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

Voyager Therapeutics is developing recombinant adeno-associated virus (rAAV) vectors for treating neurological diseases. Developing robust and reliable vector production processes is central for establishing successful gene therapy applications.  Voyager is seeking a highly motivated Sr. Associate Scientist / Engineer to join the Upstream Process Development group.  The qualified candidate will carry out process development activities for the manufacture of pre-clinical and cGMP grade rAAV products.  In addition, the candidate will also participate in internal production activities, writing appropriate documents, assisting with technology transfer activities, and participating in cGMP manufacture person in plant activities. The ability to independently organize and design experiments, analyze data and report the results of their work in a concise and well documented manner are important aspects of the position. 

Responsibilities

  •  Design, development, and optimization of cell growth, transfection, viral infection, and rAAV manufacturing using shake flasks, small-scale and large-scale bioreactors in an Sf9 / baculovirus production system
  • Assemble, sterilize, prepare, and maintain bioreactors, ancillary materials and equipment for cell culture, viral infection and harvest experiments
  • Perform monitoring of cell viability and growth, cell culture metabolites, and other measurements from cultures
  • Develop protocols for viral genome / capsid production in shake flasks, wave bioreactors and stirred tank bioreactors
  • Generate, manage, and maintain critical methods and data in a highly organized manner
  • Assist with and lead the production of nonclinical materials at Voyager
  • Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents
  • Provide support for and lead the transfer of developed protocols and upstream processes to internal and external manufacturing parties

Qualifications 

  • Bachelor’s or Master’s degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, and related fields
  • Minimum B.S. degree with 3+ years of relevant industrial experience or a M.S. degree in relevant subject matter (e.g. cell culture production of biologics) with 2+ years of industrial experience
  • Previous experience working with protein biologics or vaccines is a must, prior experience working with AAV and/or in a process development group is desired
  • Technical proficiency and experience for aspects of cell line growth optimization and production of biological products using bioreactors is required
  • Strong desire to learn multiple new techniques and willingness to provide support to more senior research personnel as required
  • Significant attention to detail and accuracy in developing and following protocols
  • Ability to be highly productive in a fluid, fast-paced and teamwork environment
To apply, email careers@voyagertherapeutics.com

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Scientist / Engineer – Upstream Process Development

Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

Voyager Therapeutics is developing recombinant adeno-associated virus (rAAV) vectors for treating neurological diseases. Developing robust and reliable vector production processes is central for establishing successful gene therapy applications.  Voyager is seeking a highly motivated Scientist / Engineer to join the Upstream Process Development group.  The qualified candidate will carry out process development activities for the manufacture of pre-clinical and cGMP grade rAAV products.  In addition, the candidate will also participate in internal production activities, writing appropriate documents, assisting with technology transfer activities, and participating in cGMP manufacture person in plant activities. The ability to independently organize and design experiments, analyze data and report the results of their work in a concise and well documented manner are important aspects of the position. 

Responsibilities

  •  Design, development, and optimization of cell growth, transfection, viral infection, and rAAV manufacturing using shake flasks, small-scale and large-scale bioreactors in an Sf9 / baculovirus production system
  • Assemble, sterilize, prepare, and maintain bioreactors, ancillary materials and equipment for cell culture, viral infection and harvest experiments
  • Perform monitoring of cell viability and growth, cell culture metabolites, and other measurements from cultures
  • Develop protocols for viral genome / capsid production in shake flasks, wave bioreactors and stirred tank bioreactors
  • Generate, manage, and maintain critical methods and data in a highly organized manner
  • Assist with and lead the production of nonclinical materials at Voyager
  • Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents
  • Provide support for and lead the transfer of developed protocols and upstream processes to internal and external manufacturing parties

Qualifications

  •  Bachelors, Masters or Ph.D. degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, and related fields
  • Minimum experience:
    • S. degree with 8+ years of relevant industrial experience
    • S. degree in relevant subject matter (e.g. cell culture production of biologics) with 7+ years of industrial experience
    • D. degree in relevant subject matter (e.g. cell culture production of biologics)
  • Previous experience working with protein biologics or vaccines is a must, prior experience working with AAV and/or in a process development group is desired
  • Technical proficiency and experience for aspects of cell line growth optimization and production of biological products using bioreactors is required
  • Strong desire to learn multiple new techniques and willingness to provide support to more senior research personnel as required
  • Significant attention to detail and accuracy in developing and following protocols
  • Ability to be highly productive in a fluid, fast-paced and teamwork environment
To apply, email careers@voyagertherapeutics.com

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Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases.  Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

Voyager is seeking a highly motivated leader to manage its expanding Analytical Development team.

The qualified candidate will be a leader within Voyager Technical Operations with a strong background and expertise in analytical development for biologics or vaccines.

Primary responsibilities will include oversee the scientific development, qualification, transfer and execution of new state-of-the-art analytical methods to be used for release and characterization of Voyager’s clinical and commercial products. This individual will also manage the team responsible for process assay support to other Development groups within the company. Ability to lead and provide guidance to a growing team of over 10 scientists is required.

Additionally, the individual will key leader in the writing and review of IND and BLAs.

This position is located in Cambridge, MA, reporting to the Chief Technical Operations Officer.

Voyager is internalizing the scientific development of most critical assays, but externalizes all GMP activities. Thus, the candidate will be required to travel, as needed, to CROs in US or overseas.

Responsibilities:

  • Lead overall analytical development and testing project plans for existing and envisioned projects
  • Develop analytical methodologies and strategies needed to progress products in the pipeline including method development, process support, formulation and stability support, product characterization and method qualifications
  • Partner with other Technical Operations functions (process development, external manufacturing and Quality) to enable aligned goals and achievement of deliverables
  • Manage and participate in tech transfer of analytical methods to CMO’s/CRO’s
  • As member of CMC team meeting, provide estimates for the resources, cost, timeline tasks, and alternative options to accomplish desired schedule
  • Coordinate the interaction of the CMC cross-functional projects among Voyager personnel, and between Voyager and the CROs.
  • Partner with External oversight team and work closely with CROs used to test GMP material, using site visits and frequent communication with CRO team members to update status of projects
  • Interact with program core teams to ensure alignment of CMC analytical development and testing plan with overall program strategy, and the requirements of pre-clinical and clinical teams
  • Monitor scope, milestones, dependencies, and costs associated with CRO project and the timelines for CRO deliverables.
  • Drive projects through project goals to ensure compliance to defined schedule.
  • Interact with finance to appraise them of changes in cost and assignment of work orders to specific functions and tasks
  • Create and maintain comprehensive risk management plan for product testing
  • Working with the CMC team, provide effective mitigation and escalation strategies for project risks and CMC issues.
  • Manage short and long-term analytical development and testing needs for projects and impact into supply of drug substance and drug product and communicate levels to internal project teams.
  • Develop and update standard internal CMC plans, based on process and historical data, to provide guidance on cost and Analytical Development FTEs required for new Development projects
  • Manage transition of CMC project from research to development and from early stage to late stage production at a CRO.
  • Strengthen and maintain relationships with key Voyager project team employees and outside vendors and suppliers of CMC services.
  • Ensure project teams adhere to company and departmental policies, procedures, and standards for storage of data related to product production
  • Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings
  • Execute all aspects of people leadership, including performance evaluations, mentorship, and ensure effective development plans for all employees

Requirements:

  • PhD or Masters in Virology, analytical chemistry, biotech, biochemistry or a related field
  • Minimum 8+ (with a PhD) or 15+ years (with an MS) of analytical development experience in industry
  • In-practice knowledge of the ICH for assay qualification and validation
  • Demonstrated ability to efficiently develop an assay from conception to a qualified/pre-validated state
  • Experience with bioassay development for biologics/vaccines/gene therapy
  • Experience managing outsourced analytical development
  • Strong project management skills
  • Candidate should be detail-oriented, self-motivated, goal driven, and should be able to work effectively on teams to progress projects.
  • Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment
  • Experience leading teams of at least 6 people
  • Ability to write and communicate effectively with cross-functional teams

Preferred Skills:

  • Experience in developing methods and performing the analysis of AAV or other similar viral vectors
  • Strong expertise in bioassay development for viral vectors
  • Industrial experience and an understanding of the biologics/vaccines drug development process is desired
  • Experience leading assay development in support of approved BLAs
To apply, email careers@voyagertherapeutics.com

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Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain. Voyager Therapeutics is developing recombinant adeno-associated virus (rAAV) vectors for treating neurological diseases. Developing robust and reliable vector production processes is central for establishing successful gene therapy applications.

Voyager is seeking a highly motivated Associate Director/Director to lead Cell Culture Development and Baculovirus Vector Engineering activities for the production of rAAV. Level commensurate with experience.

The qualified candidate will be a leader within Voyager Technical Operations with a strong background and expertise in cell culture manufacturing of biologics or vaccines. Primary responsibilities will include leading upstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products, participating in and leading internal productions, approving appropriate documents and leading technology transfer to assorted CMOs, as well as provide oversight to cGMP manufacturing activities. Additionally, the individual will also lead Voyager’s Baculovirus Vector Engineering team, tasked with the goal of developing GMP-source baculovirus vectors and optimize Voyager Sf9/baculovirus platform for production of rAAV.

Strong expertise with cell culture engineering discipline and knowledge in molecular biology is required. The ability to lead and organize multiple projects in parallel and manage and provide strategic direction to a group of ~ 10 FTEs. Excellent communication skills and ability to take the initiative to successfully drive Voyager’s projects and manufacturing process are all important aspects of the position.

Responsibilities:

  • Lead the design, development, and optimization of cell culture process conditions for rAAV manufacturing at small- and large-scale bioreactors with Sf9 / baculovirus production system
  • Design new baculovirus vectors expressing AAV for gene therapy in support of Voyager’s product pipeline
  • Lead the development of optimized constructs and improving AAV expression platform through baculovirus and/or insect cell genetic engineering
  • Author, review and approve experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents
  • Provide support for and lead the transfer of developed protocols and upstream processes to internal and external manufacturing parties
  • Drive partnerships with other TechOps and/or Research team members in in advancing Voyager’s platform and product pipeline
  • Lead as Voyager point person for and maintain various external relationships with internal and external partners, vendors and CMOs/CROs
  • Lead innovation, development and optimization of the Voyager upstream platform manufacturing process
  • Present work routinely at internal meetings and industry leading conferences, and to drive patent applications and peer-review publications

Qualifications:

  • A minimum of a Bachelor’s Degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, or related discipline is required
  • PhD degree in relevant subject matter (e.g. cell culture production of biologics) with 8+ years of industry experience in process development, or BS/MS degree with 15+ of industry experience
  • Track record of leading cell culture development for biologics and/or vaccines
  • Previous experience working with protein biologics or vaccines is a must, prior experience working with rAAV products desired
  • World-class expert in Cell Culture Engineering field. Good understanding of molecular biology
  • Excellent communication skills, and strong partnering skills and follow-up
  • Prior experience with tech transferring to a cGMP facility is a must, prior experience working with external CMOs desired
  • Prior experience managing a team of at least 5 direct and indirect reports is required. Ability to lead a diverse group of both experienced and more junior BS/MS and PhD level scientists/engineers
To apply, email careers@voyagertherapeutics.com

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Voyager Therapeutics is developing life-changing gene therapies for fatal and debilitating diseases of the central nervous system. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. The company’s pipeline is focused on severe CNS diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Huntington’s disease, Friedreich’s ataxia, Alzheimer’s Disease and neuropathic pain.

We are seeking an experienced and highly motivated neurobiologist to contribute to our research team at our facility in Cambridge, Massachusetts. This is an ideal position for an individual with a strong background in in vivo and ex vivo methods, who thrives in a team-oriented, fast-paced, and cross-disciplinary start-up biotech environment. The individual will work in the laboratory and be responsible for experimental execution and data analysis for research studies supporting cutting edge therapeutic programs and platform discovery research in neurodegenerative disease areas.   We are looking for a candidate with extensive prior experience in drug discovery in neurodegenerative diseases and with hands-on techniques in rodent in vivo studies, CNS tissue dissection, and downstream analysis (tissue sectioning, immunohistochemistry, RT-qPCR, western blot and ELISA). This position is located in Cambridge, MA and reports to a Senior Scientist.

Requirements:

  • A minimum of a Bachelor’s degree in Biology or related discipline with 5+ years of professional work experience or a Master’s degree with 2+ years of professional work experience in Biology or related discipline
  • Extensive hands-on experience in experimental execution and data analysis
  • Outstanding problem-solving skills
  • Ability to be highly productive in a fluid and fast-paced work environment
  • Hands-on experience with rodent handling, drug administration, tissue dissection and analysis
  • Experience with design, documentation and execution of experiments
  • Ability to independently analyze and present data to scientific team

Strongly Preferred:

  • Familiarity with stereotaxic brain injections
  • Working knowledge of rodent safety/tolerability assessments
  • Familiarity with molecular and biochemical methods, such as ELISA, western, and immunohistochemistry
  • Experience with participation on cross-functional therapeutic program teams
  • Experience within a start-up or small biotech environment
To apply, email careers@voyagertherapeutics.com

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Voyager Therapeutics is developing life-changing gene therapies for fatal and debilitating diseases of the central nervous system. Our founders include scientific and clinical leaders in the fields of adeno-associated virus (AAV) gene therapy, expressed RNA interference and neuroscience. Our management team has deep expertise and a track record of building exceptional life science companies.

Voyager Therapeutics seeks an experienced and highly motivated biologist to contribute to its research team at its facility in Cambridge, Massachusetts. This is an ideal position for an individual with a strong background in behavioral/system neuroscience, who thrives in a team-oriented, fast-paced, and cross-disciplinary start-up biotech environment. The individual will work at the bench and be responsible for experimental execution and data analysis for research studies supporting therapeutic programs and platform discovery research.  The successful candidate will have extensive prior experience in drug discovery and in neurodegenerative diseases.  S/he will have extensive prior hands-on expertise in performing survival surgeries including stereotaxic or direct intraparenchymal injection, pharmacological administration, rodent (mouse and rat) behavioral testing, brain and tissue collection, and downstream analysis (RT-qPCR, western blot and ELISA).

Responsibilities:

  • Drive the planning strategies to include designing and executing rodent in vivo experiments: animal handling, test article dosing via various administration routes including stereotaxic surgeries
  • Performing behavioral assays of rodent models for various neurodegenerative diseases to assess motor and cognitive dysfunction
  • Performing perfusion, tissue dissection and collection
  • Conducting ex vivo tissue analysis (ELISA, western blot, RT-qPCR, etc.)
  • Performing data analyses and delivering data presentation to the research team
  • Ensuring maintenance of industry-quality records to provide documentation

Requirements:

  • A Bachelor’s Degree with a minimum of 8 years of experience, a Master’s Degree with a minimum of 5 years of experience, or a PhD with a minimum of 1-3 years of experience in neuroscience or related discipline is required
  • At least 5 years of hands-on experience with performing survival surgeries including stereotaxic or direct intraparenchymal injection, rodent (mouse and rat) behavioral testing to assess motor dysfunction
  • Outstanding problem-solving skills and ability to multi-task
  • Experience with relevant molecular biological techniques (i.e. (RT-qPCR, western blot and ELISA)
  • Self-motivated, able to work independently, highly organized with strong attention to detail
  • Experience in rodent pharmacology experiments and blood/tissue collection
  • Competency with database, spreadsheet and presentation applications (i.e. Excel, PowerPoint, Data entry systems, or similar)

Strongly Preferred:

  • Working knowledge with neurological disease models
  • Cross-functional communication skills highly preferred
  • Experience within a start-up or small biotech environment
To apply, email careers@voyagertherapeutics.com

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Voyager is seeking a highly motivated research associate scientist with significant experience and demonstrated success with rAAV vector production to join our research team.

This research associate scientist will contribute hands-on to manufacturing and QC of diverse, in-house research-grade rAAV vectors for in vitro and in vivo research studies.  In this role, the individual will participate in upstream and downstream processing of small- to medium-scale research-grade batches of rAAV vectors using multiple production systems, as well as QC of these batches. Since multiple novel AAV capsids will be evaluated, development of new production methods will be a key component of the work. This individual will play an important role assisting the head of the group in prioritizing and planning the vector production work and implementing the plan. This is an ideal position for an individual who is energetic and thrives in a team-oriented, fast-paced, and cross-disciplinary small biotech company environment. This role is located in Cambridge, MA.

Responsibilities

  • Produce rAAV vectors using triple transfection and baculovirus/sf9 systems including generation of baculovirus expression vectors (BEVs) and baculovirus infected insect cells (BIICs), and vector QC
  • Develop and optimize protocols for production of rAAV vectors using triple transfection and baculovirus/sf9 systems, especially for novel vectors
  • Identify and apply effective resolutions to any technical challenges during upstream and downstream processes and QC
  • Optimize multiple cell culture platforms for rAAV vector production including mammalian and insect cells
  • Ensure adequate use of electronic tracking system for documenting and tracking vector production requests, status and inventory

Requirements

  • B.S in a biological science or chemical engineering (vectorology or bioprocessing focus) with minimum of 2-3 years of subsequent research, vector manufacturing, or process development experience
  • A minimum of 2 years of relevant experience in the production of biologics with a focus on rAAV viral vectors, including familiarity with different rAAV production systems, especially triple transfection and baculovirus/sf9 systems
  • Excellent organizational skills and attention to detail
  • Strong commitment to accountability for completion of objectives in accordance with established plans
  • Ability to be highly productive and flexible in a fluid and fast-paced work environment
  • Ability to troubleshoot manufacturing issues and find timely solutions
  • Strong written and oral communication skills

Strongly Preferred

  • A minimum of 2 years of experience within a start-up or small biotech environment
  • Experience in downstream processing technologies
  • Experience and knowledge of biologics and/or gene therapy vector manufacturing

 #18KG

To apply, email careers@voyagertherapeutics.com

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Principal Research Associate, Histology /Biology

Voyager Therapeutics is developing life-changing gene therapies for fatal and debilitating diseases of the central nervous system. Our founders include scientific and clinical leaders in the fields of adeno-associated virus (AAV) gene therapy, expressed RNA interference and neuroscience. Our management team has deep expertise and a track record of building exceptional life science companies.

Voyager Therapeutics seeks an experienced and highly motivated biologist to contribute to its research team at its facility in Cambridge, Massachusetts. This is a hands-on position for a person committed to conduct innovative drug discovery research while meeting deadlines and company goals. We are seeking a person who is enthusiastic about biomedical research, is capable of working independently, as well as collaboratively with other scientists and team members. This is an ideal position for an individual with extensive hands-on experience in tissue analysis such as histology, in-situ-hybridization, special stains for neuronal cell death and degeneration and immunohistochemistry methods. The applicant thrives in a team-oriented, fast-paced, and cross-disciplinary start-up biotech environment. Experience in automated image analysis, multiplexed immunohistochemistry and in-situ-hybridization, and laser capture microdissection is highly desirable. Strong knowledge of neuroanatomy would be a plus. The candidate should also be able to independently execute experiments and have good communication and interpersonal skills.

Key responsibilities

  • Highly collaborative oversight, management and execution of the daily workflow in histology to meet project and company goals
  • Own the preparation of animal specimens for histology analyses including fixation, processing, embedding, microtomy and routine/special/IHC staining.
  • Effectively and independently perform routine histology instrument operations with working knowledge of maintenance and troubleshooting.
  • Develop, validate and execute single or multiplex IHC/ISH assays with fresh frozen or fixed CNS tissues with chromogenic and Immuno-fluorescence methods to characterize the expression of transgenes, distribution and cell tropism localization of AAV in CNS tissues from difference species.
  • Perform routine/special stains for CNS tissue to evaluate the neuronal cell death and degeneration in CNS tissues
  • Execute and troubleshoot standard protocols, adapt new protocols into practice with little assistance, and query literature to incorporate additional assays as needed
  • Analyze the data and present results from studies to the group/team and train others for histology

Requirements

  • B.S./ M.S. in life sciences or related field
  • Minimum eight years of hands-on experience with excellent tissue handling, histology and multiplexed immunohistochemistry techniques. In situ hybridization and laser capture microdissection experience strong plus
  • Self-motivated, able to work independently, highly organized with a strong attention to detail
  • Good communication and presentation skills

 Strongly Preferred

  • Basic knowledge of neuroanatomy and neuroscience
  • Existing experience in pharmaceutical/ biotechnology industry
  • Experience in cross-functional therapeutic program team
  • Experience within a start-up or small biotech environment
To apply, email careers@voyagertherapeutics.com

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Senior Translational Biomarker Scientist

This is an exciting multi-faceted senior scientist role, reporting to the Senior Director, Clinical Development, in a fast-paced, innovative and dynamic environment.  The core focus of the role is to support biomarker development and utilization for multiple exciting pipeline programs as they progress into early phase clinical trials. This role will partner and work collaboratively with cross-functional team members to ensure alignment on project goals, milestones and deliverables.

Roles and Responsibilities

  • Design and deliver biomarker strategies to enable informed and efficient early clinical development.
  • Identify candidate pharmacodynamic and response biomarkers based on target biology, mechanism of action, and patient population.
  • Identify and document assays for clinical trials (primary endpoints, secondary endpoints and exploratory assays)
  • Identify and document assays for exploratory research to support Biomarker development plans
  • Collaborate with project teams, external investigators and contract research organizations to evaluate candidate biomarkers in nonclinical models and patient samples and select optimal assays for clinical evaluation
  • Oversee development, qualification, and execution of innovative assays for clinical biomarker analysis internally and with contract research organizations.
  • Identify and help qualify appropriate clinical vendors to perform all clinical assays required for a trial
  • Communicate patient sample requirements for all clinical assays and exploratory research purposes to the Clinical Scientist and/or Trial Manager
  • Transfer novel assays to the contracted clinical vendor
  • Develop “sample journey” plans for all samples required for clinical assay and exploratory research
  • For samples requiring biorepository storage, ensure that sample logistics are in place with the biorepository
  • Ensures that assays are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO)
  • Manage the progress and logistics related to the conduct of clinical assays during the trial Identify and manage close relationship with CROs in outsourcing biomarker analysis of clinical trial samples.
  • Work closely with Trial Operations in setting up logistics, tracking sample, performing data analysis and data transfer for statistical analyses.
  • Coordinate closely with Clinical Operations to develop clinical trial laboratory manuals, train clinical site staff, monitor sample collection and manage relationships with clinical trial site contacts
  • Responsible for authoring biomarker sections of clinical trial related documents including IB, IND, CSR, as well as regulatory submission.
  • Ensures appropriate decisions are made in a timely manner at the appropriate levels to drive biomarker deliverables.
  • Evaluate, interpret, and communicate clinical biomarker data to guide project decisions
  • Communicates key biomarker program information, risks, and milestones, and manages information flow across team members and senior management.

Requirements

  • Knowledge and experience operating in drug discovery and development
  • An understanding of clinical drug development and requirements for associated clinical assays
  • A PhD or PharmD in a health-related field.
  • 10+ years of experience in clinical trials and/or clinical assay development/management in a biotech or pharmaceutical setting
  • Experience in biomarker and/or genomic-related assay development or research in the pharmaceutical/biotech setting
  • Understanding of the evolving regulatory requirements for cell and gene therapy (OTAT) products in the US or ATMP products in Europe.
  • Experience with development of Cell and Gene Therapy or ATMP products, and development requirements.
  • Experience in clinical assay development
  • Strong interpersonal skills with demonstrated ability to work well in a collaborative and dynamic team environment
  • Strong analytical and problem-solving skills; ability to combine attention to detail with big picture perspective
  • Excellent written and oral communication, including presentation, negotiation, team building, and facilitation skills
  • Excellent organizational skills, able to work independently and proactively, prioritize and manage multiple tasks simultaneously
  • Proven effectiveness in a quick-changing, fast-paced environment, a strong team player with high energy and a can-do attitude.
To apply, email careers@voyagertherapeutics.com

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Senior Manager, Marketing & Commercial Development

This is an exciting multi-faceted, newly created, commercial role, in a fast-paced, innovative and dynamic environment.  The core focus of the role is to support advancement of market and commercial development in advance of the launch of Voyager’s lead program, VY-AADC, gene therapy for Parkinson’s Disease, and as such requires a broadly capable “utility player” to both help shape and develop commercial strategy in a nascent team setting while personally owning implementation of the strategy through tenacious day-to-day tactical execution.  This role will partner and work collaboratively with internal and external, cross-functional team members to ensure alignment on project goals, milestones and deliverables. The ideal candidate will possess a broad view of the healthcare system, the ability to think creatively when introducing new therapies and a proven track record of getting things done.

This position offers an extraordinary opportunity in a therapeutic area with high unmet needs, translating market insights into actionable activities to make treatment available to all appropriate patients.

Key Responsibilities

  •  Develop market and customer insights to shape critical success factors and initiatives, ensuring clarity on scenarios that are likely to impact successful commercialization
  • Co-lead the development and execution of brand and communication initiatives in support of both drug and delivery
  • Support strategic brand architecture and expression development and manage implementation
  • Co-lead development of market development plans and execute in support of global go-to-market strategy
  • Partner across functions to develop and maximize the value of Voyager commercial assessments
  • Coordinate global pricing strategy work
  • Co-lead communications efforts related to data readouts, product milestones, and key congresses

Minimum Requirements

  •  MBA/graduate degree
  • 8+ years of relevant marketing & commercial experience spanning at least two of: pharma/biotech, medical devices, hospital/IDN or payor/provider experience
  • 5+ years broad relevant professional experience
  • Pharmaceutical, biotech, or relevant consultant firm experience
  • Willingness & proven ability to personally produce high quality work as a hands-on individual contributor in a fast-paced small company setting
  • Proven ability to successfully manage multiple external agency and consultancy partners simultaneously
  • Strong analytical skills; ability to synthesize and evaluate information, draw conclusions and make recommendations
  • Exceptional communication and collaboration skills

 

Preferred Qualifications

  •  Smaller start- up company or entrepreneurial experience
  • Robust people management experience with a proven track record of talent acquisition and development

 

To apply, email careers@voyagertherapeutics.com

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Industrial Co-Op Opportunity on Insect cell/baculovirus production of AAV (Approx. 12 months Contract‐ Available October 2018, )

Project Title:
‐ Kinetics of adeno associated virus (AAV) production with the insect cell baculovirus expression
system

Scope:
‐ This project will develop processes and methods to monitor, characterize and understand the kinetics
of AAV production using an insect cell baculovirus system.
‐ The goal of this project is to first characterize the system dynamics and then develop rational
strategies for optimization of AAV production
‐ The individual will use established and will develop novel methodologies to enable qualitative and
quantitative measurements of cell parameters, critical metabolites, baculoviruses, and AAV products
in small scale systems, e.g. shake flasks, as well as fully instrumented bioreactors.
‐ Additionally, this project aims to find insights between different process conditions (e.g. pH, DO,
pCO2, nutrients, production scale, shear, etc…), their interplay and overall AAV production dynamics
Duration:

Candidate Qualifications:

– Currently enrolled in a PhD granting program in Chemical/Biochemical Engineering or similar areas.
‐ PhD thesis with emphasis on insect cell baculovirus bioprocessing (required).
‐ At least 2 years of hands-on experience with insect cell culture and baculovirus expression (required)
‐ Experience in AAV production with BEVS (preference, but not required)
‐ Undergraduate in Chemical/Biochemical Engineering or similar areas
‐ In-depth expertise of insect cell metabolism and baculovirus biology
‐ Hands-on experience with operating fully instrumented bioreactors and knowledgeable of bioreactor
scale-up principles
‐ Experience in multiple analytical techniques, such as ELISA, PCR, HPLC, Flow cytometry, etc..
‐ Good communication skills. Oral and writing.

To apply, email careers@voyagertherapeutics.com

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Position Summary

The Director, Human Resources will play an important role in the Voyager organization.   This new role will focus on organizational development, employee development and culture within our fast growing organization.   This new leader will build and maintain strong relationships with Voyager leadership, and and will provide advice and support on talent management, employee relations, communications and longer-term organizational planning.   The Director will focus on developing and implementing programs which build core skills, accelerate learning, provide real-time feedback and improve cross-functional information sharing and engagement.   This position will lead all business partner work, and will develop a team who can effectively build and scale our organization, while maintaining the critical elements of our culture and identity.

Responsibilities

  • Build relationships with organizational leaders to understand evolving needs for critical HR programs that helps align needs and program priorities.
  • Develop strong, real-time talent management system which links our people to critical company goals, and provides frequent feedback on performance and opportunities to grow and learn
  • Act as coach and advisor to managers at all levels on effectively managing people.   Help design key training and development solutions that strengthen manager capabilities
  • Enhance company communication vehicles across the organization in a way that promotes culture, key learning, effective information sharing and skill building.   Develop effective means to communicate basic program requirements such as policies, tools & templates, etc.
  • Manage rollout of annual engagement survey and follow up with communication of results and design and implementation of key action plans to maintain positive results, improve in opportunity areas
  • Review and improve company communications on job requirements, career paths, recruiting postings to establish compelling descriptions of our work with clear expectations on performance success
  • Promote strong culture through review and design of key organizational processes, from onboarding through all areas of employee experience.   With team, improve and redesign processes to enhance effectiveness while keeping process simple and scalable
  • Develop short and long-term goals at each functional level, and design solutions which fit both broad organizational needs and functional-specific solutions
  • Work with HR Operations Manager to design and share key metrics on organizational performance and employees, including talent management, talent acquisition, compensation competitiveness, retention, and other areas

Experience and Skills Desired

  • Bachelor’s Degree required, advanced study in relevant field desirable
  • Minimum of 10 years of progressive HR experience in business partner roles, with broad generalist knowledge in employee relations, compensation, organizational development, training and talent acquisition.
  • Biotech or pharma industry experience required
  • Strong relationship building and coaching skills at all levels of the organization
  • Excellent project management and organizational skills
  • Solid business acumen, with ability to analyze data, manage budgets and measure results and effectiveness of programs
  • flexible, resourceful, and with a great sense of humor, ability to work effectively on multiple tasks on deadline and under pressure with grace and success
  • Strong communication skills, both as an effective writer and presenter of information
  • Strong interpersonal and problem-solving skills are required
To apply, email careers@voyagertherapeutics.com

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Director of Talent Acquisition

Voyager seeks its first Director of Talent Acquisition to lead our ongoing efforts to attract and retain outstanding talent in our fast-growing organization.  

The Director will manage current talent acquisition efforts while building processes, brand, team and strategy to insure longer-term success and alignment with key organizational goals.   This role will oversee the full recruiting cycle from planning through successful onboarding, and will help develop the Voyager recruiting process to continue to deliver strong candidates with an effective process and positive candidate experience.

Responsibilities

  • Lead the talent acquisition team, and manage staffing to support workforce needs.
  • Partner with business leaders to enhance current recruitment efforts and pipeline development. develop longer-range plans for recruiting readiness aligned with company’s plans
  • Develop effective recruitment strategy for each area of the organization, identifying current and future candidates from a variety of sourcing methods
  • Build competitive knowledge of gene therapy, neuroscience, both in industry and academic worlds,  and other key areas to accelerate sourcing of highly qualified talent for current and future needs.
  • Define Voyager recruitment process, establishing and training in best practices for sourcing, screening, interviewing, referencing and feedback, negotiation of offers, onboarding and all candidate interactions and communications
  • Enhance Voyager’s efforts on branding and messaging and develop plan for effective recruiting messaging with audiences including candidates and partners
  • Evolve company’s recruiting techniques to assess candidates on both skills and culture fit to maximize fast integration and likely retention.  Promotes company core values and importance of diversity and inclusion
  • Lead implementation of new applicant tracking system, train managers on Voyager process and use of new system and tools
  • Review and report on recruiting effectiveness using metrics which assess progress and success
  • Build relationships with key external partners for specialized staffing needs or for additional resourcing needed to attract and engage target candidates

Experience and requirements

  • Bachelor’s degree required, with 10+ years of recruiting experience, including some managing recruiters
  • Biotech work experience required, with demonstrated track record in recruitment
  • Highly organized, effectively multi-tasker who can build processes and organization
  • Excellent communicator and relationship builder who can develop talent, give effective feedback
  • Strong professional presentation who is a highly effective representative for Voyager
To apply, email careers@voyagertherapeutics.com

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Medical Writer

Voyager is seeking a Medical Writer to support a cross-functional team including Medical, clinical, CMC, and regulatory; the position will report to Medical Affairs. We are looking for a full-time contract writer for a minimum of 6 months with the potential to convert to a permanent position.

This individual will provide writing, editing, and project management support to the development of clinical documents, CMC, clinical, and medical publications and congress presentations, and regulatory filings as needed.

The ideal candidate will have a minimum of 3 years of writing experience for CMC, clinical, and/or regulatory clients and a desire to move into a more Medical Affairs-focused role.

Minimum requirements

  • Bachelor’s degree in a relevant scientific discipline; advanced degree strongly preferred
  • Three years of writing experience either in-house or as a contractor to biotech or biotech support (e.g. CRO, medical writing agency) organizations
  • Excellent writing and editing skills
  • Strong on-line database/literature search skills
  • Strong project management skills with proven ability to drive projects to completion on an agreed timeline
  • Intermediate MSWord and PowerPoint user
  • Ability to work effectively across disciplines and writing styles

Preferred qualifications

  • Understanding of statistics
  • Experience with early-stage clinical, CMC, and regulatory development
  • Experience working in or for a matrixed organization
  • Working knowledge of EndNote
  • Experience working with or managing support agencies

Must be local to Cambridge, MA. May work remotely if available on an as-needed basis to be in-house on short notice.

To apply, email careers@voyagertherapeutics.com

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Senior Scientist – Analytical Sciences Outsourcing

 Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases.  Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector optimization and engineering, dosing techniques, as well as process development and production. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia, Huntington’s disease, spinal muscular atrophy (SMA), frontotemporal dementia and Alzheimer’s disease and severe chronic pain.

Voyager is seeking a highly motivated scientist to manage the Analytical Development and Testing conducted at External Contract Research Organizations (CROs). The qualified candidate will be responsible, in collaboration with Voyager’s Analytical Development and Quality, to oversee the qualification, transfer and execution of new state-of-the-art analytical methods to be used for release and characterization of Voyager’s clinical and commercial products at external CROs. Additionally, the individual will partner closely with Manufacturing to ensure constantly update status of lot release and any pending investigation or other issues requiring speedy resolution.

This position is located in Cambridge, MA, reporting to the Director, External Manufacturing & Supply. The candidate is required to travel, as needed, to CROs in US or overseas. Travel requirements will vary but may be up to 50%, as needed.

 

Primary responsibilities

  •  Develop external analytical development and testing project plans for existing and envisioned projects, with input from other Technical Operations functions (process development, analytical development, manufacturing and Quality)
  • Manage and participate in tech transfer of analytical methods to CMO’s/CRO’s
  • Develop analytical methodologies and strategies needed to progress products in the pipeline including method development, process support, formulation and stability support, product characterization and method qualifications
  • As member of CMC team meeting, provide estimates for the resources, cost, timeline tasks, and alternative options to accomplish desired schedule
  • Coordinate the interaction of the CMC cross-functional projects among Voyager personnel, and between Voyager and the CROs.
  • Work closely with CROs used to test GMP material, using site visits and frequent communication with CRO team members to update status of projects
  • Interact with program core teams to ensure alignment of CMC analytical development and testing plan with overall program strategy, and the requirements of pre-clinical and clinical teams
  • Monitor scope, milestones, dependencies, and costs associated with CRO project and the timelines for CRO deliverables.
  • Drive projects through project goals to ensure compliance to defined schedule.
  • Interact with finance to appraise them of changes in cost and assignment of work orders to specific functions and tasks
  • Create and maintain comprehensive risk management plan for product testing
  • Working with the CMC team, provide effective mitigation and escalation strategies for project risks and CMC issues.
  • Manage short and long-term analytical development and testing needs for projects and impact into supply of drug substance and drug product and communicate levels to internal project teams.
  • Develop and update standard external CMC plans, based on process and historical data, to provide guidance on cost and FTEs required to manage and produce GMP material for new Development projects
  • Manage transition of CMC project from research to development and from early stage to late stage production at a CRO.
  • Strengthen and maintain relationships with key Voyager project team employees and outside vendors and suppliers of CMC services.
  • Ensure project teams adhere to company and departmental policies, procedures, and standards for storage of data related to product production
  • Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings

Minimum Qualifications

  • PhD or Masters in analytical chemistry, biotech, biochemistry or a related field
  • Minimum 5+ (with a PhD) or 15+ years (with an MS) of analytical development experience in industry
  • In-practice knowledge of the ICH for assay qualification and validation
  • Demonstrated ability to efficiently develop an assay from conception to a qualified/pre-validated state
  • Experience with bioassay development for biologics/vaccines/gene therapy
  • Experience managing outsourced analytical development
  • Strong project management skills
  • Candidate should be detail-oriented, self-motivated, goal driven, and should be able to work effectively on teams to progress projects.
  • Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment
  • Ability to write and communicate effectively with cross-functional teams

Preferred Qualifications

  • Experience in developing methods and performing the analysis of AAV or other similar viral vectors
  • Industrial experience and an understanding of the biologics drug development process is desired.
To apply, email careers@voyagertherapeutics.com

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Director, External Manufacturing and Supply

Voyager Therapeutics is developing recombinant adeno-associated virus (rAAV) vectors for treating neurological diseases. Developing robust and reliable vector production processes is central for establishing successful gene therapy applications. Voyager is seeking Director, External Manufacturing and Supply who will manage multiple CMC projects with CMOs, as well as the overall Supply Chain network for clinical material distribution.

This role leads external manufacturing function at Voyager and assists the cross-functional interaction among the internal development team (process development, analytical development and Quality teams) and the CMO, particularly being responsible for the interaction with the CMO project managers.  S/he develops CMC project budgets, timelines, and risk assessments, and is responsible for performance against these parameters.  The individual actively monitors and reports on project status, the financial status of the work within the CMOs, interacts regularly with the program core team and other functions as necessary to communicate the risks and decisions required and highlights assumptions associated with CMC timelines.

The role reports into the Voyager Chief Technical Operations Officer and supervises Manufacturing Sciences engineers in charge of CMO oversight. This position is located in Cambridge, MA and will travel 20-50% ( U.S. / Int’l ).

Responsibilities

  • Develops and implements overall strategy for External Manufacturing and Supply, in collaboration with other Technical Operations functions
  • Lead the development of external CMC project plans for existing and envisioned projects, with input from other Technical Operations functions (process development, analytical development, and Quality)
  • Manages overall External Manufacturing budget and spent, carefully balancing risk and cost
  • Responsible for external GMP warehouse and storage facilities for cell lines and virus banks, DS and DP, and the overall Supply Chain network for clinical trial material distribution
  • As member of CMC team meeting, provide estimates for the resources, cost, timeline tasks, and alternative options to accomplish desired schedule
  • Coordinate the interaction of the CMC cross-functional projects among Voyager personnel, and between Voyager and the CMOs.
  • Work closely with CMOs used to produce GMP material, using site visits and frequent communication with CMO team members to update status of CMC project
  • Interact with program core teams to ensure alignment of CMC plan with overall program strategy, and the requirements of pre-clinical and clinical teams
  • Monitor scope, milestones, dependencies, and costs associated with CMO project and the timelines for CMO deliverables.
  • Drive projects through project goals to ensure compliance to defined schedule.
  • Interact with finance to appraise them of changes in cost and assignment of work orders to specific functions and tasks
  • Create and maintain comprehensive risk management plan for product production
  • Working with the CMC team, provide effective mitigation and escalation strategies for project risks and CMC issues.
  • Manage short and long-term project commitments to supply of drug substance and drug product and communicate levels to internal project teams.
  • Develop and update standard external CMC plans, based on process and historical data, to provide guidance on cost and FTEs required to manage and produce GMP material for new Development projects
  • Manage transition of CMC project from research to development and from early stage to late stage production at a CMO.
  • Strengthen and maintain relationships with key Voyager project team employees and outside vendors and suppliers of CMC services.
  • Assist in coordinating key vendor and supplier evaluations, particularly those supplying services related to raw material supply, product manufacturing, release, storage, and characterization.
  • Ensure project teams adhere to company and departmental policies, procedures, and standards for storage of data related to product production.

Qualifications

  • Minimum PhD in Chemical Engineering with 10+ experience with processes to make biologics, viral vectors or vaccines, or BS\MS degree in Chemical Engineering with 20+ years of experience with processes making biologics, viral vectors or vaccines
  • Experience with planning and managing CMC aspects of biopharmaceutical development
  • Experience in process development and process transfer, focused on biologics or proteins, viral vectors or vaccines
  • Experience in CMO search, selection and management
  • Experience as person in plant (PIP) for production of biopharmaceutical products
  • Ability to travel ( U.S./ Int’l ) 25-50% of time, particularly when production campaigns are being done
  • Has demonstrated the ability to organize external resources to maximize quality and efficiency. Maintains an overview of the entire process when planning a project, setting both short and long-term goals.
  • Works effectively aligning actions to project targets, milestones, and priorities.
  • Excellent communication skills, with the ability to provide clear and audience-focused descriptions of CMC tasks and issues, and proposed solutions to schedule challenges, all done in an open and honest manner.
  • Able to achieve goals in a timely manner, despite obstacles, by prioritizing tasks and building in contingency planning. Results oriented and demonstrates a focus on getting (business) results.
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal (and sometimes external) stakeholders.
  • Familiar with current issues and Regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production
  • Familiar with trends and developments in the gene therapy field and able to translate those developments into specific business advantages and risks related to production.
  • Proficiency with Microsoft Office suite (e.g. Word, Excel, PowerPoint, Project, Outlook).
To apply, email careers@voyagertherapeutics.com

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Director, Patient Advocacy

Voyager Therapeutics is looking for a creative, energetic, compassionate, and clinically oriented person to manage programs, communications, and organizational relationships in patient advocacy.  This individual should be committed to supporting active programs and clinical development efforts within Voyager by building collaborative relationships with foundations and patient organizations. The role will report directly to the CMO and will work closely with multidisciplinary teams.

 The successful incumbent will establish and maintain strong relationships with key patient organizations that will provide:

  • Insight into unmet clinical needs, attitudes toward and understanding of gene therapy and route administration.A keen understanding of patient experience of current medical care including costs and barriers to treatment
  • A collaborative approach to implementation of Voyager’s preclinical and clinical stage programs, and potential commercialized products
  • An understanding of patient experiences broadly and specific perspectives on Voyager clinical studies.
  • Develop and implement a patient advocacy strategy that will support all stages of development in collaboration with key functions including clinical development, regulatory, commercial, medical affairs, market research and communications teams.
  • Develop and implement educational and outreach programs to inform and engage Voyager staff and build strong working relationships with patient groups across the organization.

Responsibilities

Develop and maintain strong relationships with key patient groups, foundations, and non-profit organizations, in the US and targeted international markets.

  • Work with relevant Voyager teams to build partnerships and initiatives with these organizations to support development efforts. These may include:
    • Epidemiology studies
    • Natural history studies and patient registries
    • Biomarker development
    • Recruitment and retention efforts in clinical studies
    • Product profile development
    • Education and communications strategy
    • Patient advisory board planning and implementation
  • Recruit and develop Patient/care giver, opinion leaders to lead and build patient support groups and communities both online and off-line.
  • Contribute patient/provider perspectives in preparation and planning of clinical studies, regulatory efforts, and other relevant initiatives within Voyager.
  • Build involvement of organizations in regulatory and advocacy efforts as appropriate.
  • Maintain and expand Voyager’s network of patient opinion leaders.
  • Coordinate internal Voyager events and education efforts regarding disease knowledge and patient perspective.
  • Maintain outreach efforts to connect with new organizations, including those relevant to new and/or potential programs and to broader areas relevant to Voyager’s mission.
  • Manage company commitment to organizations, including event sponsorships, employee involvement, and communications around ongoing organizational initiatives.

 Minimum Requirements

  • BA/BS degree in science or health related area. Degrees in medicine (MD), nursing (RN), public health (MPH), relevant advanced degree (PharmD, PhD), or significant relevant experience as a genetic counselor or similar medical professional are strongly preferred.
  • Minimum of 7 years in the pharmaceutical, biotechnology or healthcare industry required, with demonstrated ability to cultivate and manage strong relationships with key internal and external stakeholders.
  • Excellent oral and written English communication skills. 
  • Demonstrated strategic and critical thinking skills.
  • Ability to interact externally and internally across functions to support the clinical, scientific, and business strategy.
  • Ability to exercise judgment and address complex problems to create solutions across multiple stakeholders with varying interests and perspectives.

 

 

To apply, email careers@voyagertherapeutics.com

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To apply or learn more about career opportunities at Voyager Therapeutics, please email careers@voyagertherapeutics.com.

Note to Employment Agencies: Please do not forward agency resumes. Voyager Therapeutics is not responsible for any fees related to resumes that are unsolicited and out of executed contracts.

Voyager Therapeutics will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Equal Opportunity Employer M/F/D/V