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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

CMC Project Manager

Voyager is seeking a CMC Project Manager who will proactively manage multiple CMC projects with CMOs.

This role coordinates, supports, and assists cross-functional interaction among the internal development team and the CMO and is responsible for the interaction with CMO project manager.  S/he develops CMC project budgets, timelines, and risk assessments and is responsible for performance against these parameters.  The individual actively monitors, owns and reports on timelines and   project status, and 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.This position reports to the Vice President, Program Management and is located on-site in Cambridge Massachusetts.

Responsibilities

  • Coordinate the interaction of the CMC cross-functional projects or programs among Voyager personnel and between Voyager and partner CMOs for defined, managed CMC timelines.
  • Develop CMC project plans for multiple existing and envisioned projects.
  • Create, manage and monitoring scope, milestones, dependencies, risks, and costs associated with each project and CMO.
  • Interact with program core teams to ensure alignment of CMC with overall program strategy
  • Interact with finance to appraise them of changes in risks, cost and assignment of work orders to specific functions and tasks
  •  Maintain these inputs and create comprehensive risk management plan against these risks and provide that information to the team and senior management
  • Develop a standard CMC plan for Voyager to provide guidance on cost and FTEs requirements related to Research projects which move into Development
  • Create project communication tools, such as project dashboards, CMC team meeting minutes and summaries, resource and time line plans and staffing to accomplish these plans
  • Solidify and maintain relationships with key customers (within and outside Voyager), vendors, and suppliers. Manage key stakeholder and project manager commitment levels and communication. Assist in coordinating key vendor and supplier evaluations, particularly those supplying services related to storage, manufacturing and raw material release and characterization.
  • Ensure projects follow company and departmental policies, procedures, and standards, particularly focused on storage of data related to projects.
  • Identify and highlight project risks and issues related to tasks and timelines and escalate appropriately. Working with the CMC team, provide effective mitigation and escalation strategies for projects to address risks and issues.
  • Follow project governance structures and processes to drive and manage the project. Manage implementation of project management methodology and governance tools, particularly defined project goals for transition from research to development and from early stage to late stage. Drive projects through project goals to ensure compliance to defined schedule and staffing goals
  • Lead regular CMC project and program reviews with Program Managers and key stakeholders.

 

Qualifications

  • Minimum Bachelor’s degree, Masters preferred
  • Minimum 4 years of Project Management experience and 5-7 years active Biotech CMO Management. Experience with planning and managing all phases of biopharmaceutical development
  • Experience in managing projects focused on biologics or proteins within smaller company environment
  • Familiarity with trends and developments in that field and is able to translate those to the specific business context.
  • Excellent communication skills with the ability to provide, clear, persuasive arguments expressing CMC Project Management concepts and information appropriate to the audience communicated in an open and honest manner.
  • 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.
  • Results oriented and demonstrates a focus on getting (business) results and works effectively towards targets, milestones and priorities.
  • Has demonstrated the ability to organize resources to maximize quality and efficiency. Maintains an overview of the entire process when planning a project, setting both short and long-term goals.
  • Able to achieve goals in a timely manner despite obstacles by organizing and prioritizing tasks and building contingency. Beating targets, going beyond what was set, or defining own higher goals.
  • Proficiency with Microsoft Office suite (e.g. Word, Excel, PowerPoint, Project, Outlook).

 

 

To apply, email careers@voyagertherapeutics.com

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Scientist I, Process Development (Downstream Focus)

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 to join the Process Development Group with a downstream purification focus.  The qualified candidate will primarily carry out downstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products.  In addition, the candidate will participate in and lead internal productions, technology transfer to assorted CMOs and cGMP manufacture person in plant activities.  The ability to independently organize and design experiments while analyzing data and reporting the results of their individual work in a concise and well documented manner are important aspects of the position.  

Responsibilities

  • Perform benchtop and preparative separations of rAAV particles from an insect cell line using various filtration, TFF, centrifugation and chromatographic techniques
  • Develop protocols for viral genome\capsid purification using column chromatography / Akta protein purification systems
  • Complete concentrations and diafilitrations using hollow fibers and small plate and frame TFF systems
  • Carryout Pmax and Vmax studies for depth and sterile filtration development
  • Make reagents and solutions required for production protocols
  • Perform viral removal / inactivation steps and qualification studies
  • Provide support for and lead the transfer of developed protocols and downstream processes to internal and external manufacturing parties
  • Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents

Qualifications

  • Degree in biology, biochemistry, chemistry, biotechnology, chemical engineering or related fields
  • Bachelor’s degree with a minimum 8 years of laboratory experience or PhD degree with 2-4 years laboratory experience
  • Previous experience working with protein biologics or vaccines is a must, prior experience working with rAAV products desired
  • Proficient with the use of Akta and other chromatography systems, UF\DF systems, and cell filtration devices
  • Strong desire to learn multiple new techniques and willingness to work as part of 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
To apply, email careers@voyagertherapeutics.com

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Scientist I, Process Development (Upstream Focus)

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 to join the Process Development Group with an upstream production focus.  The qualified candidate will primarily carry out upstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products.  In addition, the candidate will participate in and lead internal productions, technology transfer to assorted CMOs and cGMP manufacture person in plant activities.  The ability to independently organize and design experiments while analyzing data and reporting the results of their individual 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 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 in the production of nonclinical materials
  • 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

  • Degree in biology, biochemistry, chemistry, biotechnology, chemical engineering or related fields
  • Bachelor’s degree with a minimum 8 years of laboratory experience or PhD degree with 2-4 years laboratory experience
  • 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 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
To apply, email careers@voyagertherapeutics.com

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Research Associate I, Process Development (Upstream Focus)

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 Research Associate to join the Process Development Group with an upstream focus.  The qualified candidate will be responsible for maintaining various insect cells lines, monitoring cell growth, nutrient and metabolite trends, and determining productivity of said cultures.  Additionally, the candidate will assist with staging, monitoring and analyzing bench-top and large-scale stir tank bioreactors for upstream optimization and scale up / scale down experiments.  Finally, the candidate will also assist with various viral banking activities within the group.  Work activities will also include following / preparing protocols, SOPs and final study reports, as well as assorted laboratory maintenance duties.

This position is located in Cambridge, Massachusetts

Responsibilities

  • Maintain various insect cell line cultures for use by the Process Development Group
  • Perform monitoring of cell viability and growth, cell culture metabolites, and other measurements from bioreactors and shake flasks
  • Assemble, sterilize, prepare, and maintain bioreactors, ancillary materials and equipment for cell culture and harvest experiments
  • Carryout, monitor and assist with various viral banking and optimization activities
  • Generate, manage, and maintain critical methods and data in a highly organized manner
  • Assist in the production of nonclinical rAAV materials
  • Prepare / follow protocols, SOPs, batch records, and reports

Qualifications

  •  Bachelor’s degree in biology, biochemistry, chemistry, biotechnology, chemical engineering or related fields
  • A minimum of 1 year of cell culture / aseptic technique experience is required; preferred that experience is in either an industrial, process development or pharmaceutical co-op setting
  • Strong writing, verbal, and organizational skills
  • Highly motivated and a self-driven individual with the ability to work in a fast-paced, start-up environment
  • Previous experience working with the upstream production of protein biologics, vaccines, rAAV viral vectors and/or baculovirus in mammalian or insect systems desired
To apply, email careers@voyagertherapeutics.com

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Executive Assistant to Chief Financial Officer (C- Level)

Voyager is seeking a highly-motivated and proactive executive administrative professional to join our rapidly growing organization. The successful candidate will provide dedicated C-Level administrative support to the CFO and Voyager’s Senior Leadership Team ( Legal, Finance ). Good judgment and discretion are required while working with sensitive and confidential information. This role requires the ability to manage multiple priorities and work collaboratively with other administrative staff to ensure that all support needs are met in keeping with company objectives, deadlines and rapidly changing priorities. This position is located on-site at Voyager’s headquarters in Cambridge, Massachusetts.

Responsibilities:

Proactively plan, organize, and manage complex Executive schedules/calendars using Microsoft Outlook, including prioritizing and managing conflicting responsibilities in a fast-paced environment.

  • Liaise with cross functional departments with courtesy and professionalism to facilitate and coordinate meetings with internal / external partners, alliances and resources
  • Coordinate complex U.S. and international travel arrangements and anticipate alternative solutions as needed.
  • Ensure internal and external guest meetings/ events run efficiently and on time
  • Prepare and proactively maintain complex itineraries
  • Track individual travel expenditures and prepare and submit expense reports
  • Prepare, coordinate and execute verbal and written communications with meticulous detail and accuracy
  • Maintain discretion and open lines of communication that represent Voyager effectively with internal and external groups
  • Partner (as back up) toward design and delivery of presentations, as needed, with EA Team peers. This may include documents/reports for meetings, seminars, and special projects using the Microsoft Office Suite (particularly with Outlook, PowerPoint, Word, and Excel)
  • Contribute to and take pride as, an ambassador for Voyager company culture
  • May assist Administrative Team with ad hoc projects as needed

 Requirements: 

Bachelor’s degree with minimum 10 years of professional executive administrative   Prior experience in a C-Suite support role in biotech/ life sciences industry preferred

 

Additional Skills:

  • Superior organizational, administrative and time management abilities in a fast- paced environment
  • Ability to work effectively with multiple leaders and manage and prioritize multiple priorities and projects with strong attention to detail 
  • Demonstrated team player while also able to operate independently
  • Able to handle sensitive situations and confidential information with professionalism, good judgement and discretion 
  • Superior business judgment making decisions pertaining to expenses, travel, and priorities in accordance with executive direction and Voyager Best Practices
  • Strong analytical and critical thinking skills
  • Positive interpersonal skills (enthusiastic, upbeat) with the ability to interface effectively with a wide variety of internal and external clients 
  • Excellent verbal and written communication skills 
  • Proactive, self-motivated and flexible, with an ability to learn and adapt to new systems as they evolve 
  • Advanced proficiency with Outlook, Excel, PowerPoint, and Word 
  • Proficiency with A/V online meeting/conference tools for meeting scheduling  

To Apply: Please send update CV to careers@voyagertherapeutics.com

 

 

 

 

 

To apply, email careers@voyagertherapeutics.com

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Senior Quality Assurance Specialist

The Senior Quality Assurance Specialist will conduct GMP and other GxP audits as directed, have oversight and responsibility for GMP compliance for the production of Clinical Trial Material (CTM), and Contract Manufacturing Organizations (CMOs) inclusive of the review of Master Batch Documentation and completed batch documentation for product release.  The Senior Quality Assurance Specialist will be involved in the implementation and maintenance of the Quality Systems Manual including support of training activities. Provide assistance in the audit and oversight Contract Research Organizations (CROs) as directed and necessary.  The incumbent will work directly with the Director, Quality Assurance to ensure that company goals and objectives are met and that compliance risks are identified and communicated to senior management. This position is located in Cambridge, MA.

  • Primary reviewer of CMO Master Batch Records (MBRs) and executed batch records, and approve as delegated by the Director, Quality Assurance.
  • Participate with Manufacturing Sciences in investigations of deviations ensuring the development of Corrective Actions and Preventative Actions (CAPA), as necessary.
  • Review and approve Technical Transfer Documents and CMO Protocols & Reports.
  • Lead the development of Technical Quality Agreements for CMOs and CROs.
  • Develop, review and contribute to Policies and SOPs in support of the Quality Systems Manual.
  • Review and approve Policies and SOPs authored and developed by other functional areas.
  • Conduct GMP audits of suppliers and CMOs. Assist in audits of Contract Research Organizations (CROs) and clinical sites, as necessary.
  • Conduct and maintain New Employee Quality Orientation and Quality Refresher Training with primary responsibility for the Training System including documentation.
  • Assist Clinical Operations in the development of Clinical Protocols, Investigator Brochures, Pharmacy Manuals, and other clinical documents as requested and directed by the Director, Quality Assurance.
  • Participate in the company internal compliance audit program.
  • Represent Quality in assigned cross-functional Program Teams.
  • Participate in the preparation of Chemistry and Manufacturing Control (CMC) sections inclusive of data verification and audits.
  • Participate in the development of Regulatory Authority inspection strategies.
  • Assist in the development and implementation of Quality Metrics and overall Quality Compliance Strategy.
  • Develop and maintain tracking logs and files, as applicable
  • Effectively communicate progress and issue resolution to the Director, Quality Assurance and key stakeholder of the Program Teams.

Qualifications and Experience:

  • BS in chemistry, pharmacy, biochemistry or related discipline
  • Minimum of 10 years QA GMP experience in biotech/pharmaceutical environment required. GCP and GLP experience a plus.
  • Demonstrated experience working with CMOs and conduct of GMP compliance audits of CMOs and/or suppliers.
  • Demonstrated knowledge and understanding of quality compliance principals with specific focus on GMPs (CRO compliance knowledge a plus).

Additional Experience Desired:

  • Biological Drug Substance production
  • Production of Injectable Products
  • Developed and conducted employee training
  • Involvement with Clinical Operations (CROs desirable)
  • Excellent technical writing and problem-solving skills
  • Some domestic travel required (approximately up to 20%).
To apply, email careers@voyagertherapeutics.com

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 Associate Director, Regulatory Affairs CMC

The Associate  Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager’s gene therapy products. These responsibilities will be in line with corporate objectives and are to be achieved in coordination with key internal and external team collaboration partners. The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries/reports for CMC sections of INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and coordinate responses during the review/approval by Regulatory authorities. This role will also be responsible for the content of the CMC section of briefing documents for pre-IND, End of Phase 2, and pre-BLA meetings in the US and scientific advice in the EU plus supporting CMC materials for meetings with PMDA in Japan.  Ensure accuracy of CMC requirements for validated analytical testing and manufacturing of Phase 3 material, including commercial product specifications are met according to Health authority requirements and expectations to efficiently progress clinical trials, submissions and approvals on a global basis. During health authority inspections, the Associate Director of Regulatory CMC will provide relevant documentation, support and rationale concerning Regulatory CMC submissions.    This position reports to the Senior Vice President of Regulatory Affairs and Quality Assurance and is located in Cambridge, MA.                                                                                                                                                                                                    

Responsibilities

  •  Provide innovative and proactive regulatory strategy for CMC development of gene therapy products for all project teams in early research and all stages of clinical development.
  • Design and execute an effective global regulatory CMC strategy in alignment with the overall development plan and corporate goals that will meet all Health authority regulations and support registration and approval.
  • Work closely internally and with Alliance partners in Manufacturing and Quality Assurance including other disciplines to prepare and execute global submissions addressing the needs of each partner.
  • Lead, supervise and author all CMC sections of submissions throughout the product’s life cycle, including briefing documents, INDs, and various Health authority requests for additional information.
  • Prepare the team and lead negotiations with FDA and other health agencies regarding all manufacturing questions.

Qualifications

  • Bachelor of Science Degree and relevant experience, or MS, PhD degree preferred.
  • Minimum 10 years experience working in Regulatory Affairs; ideally 7 plus years in the biotech industry (gene therapy, monoclonal antibodies, vaccines, blood products, and/or cell products) including preferably experience in a small biotech company environment
  • Sound depth of knowledge and expertise in Regulatory Affairs, including all associated requirements
  • Pharmaceutical industry experience in successfully transitioning from Phase 1 clinical trial material to Phase 3 and commercial GMP quality material with a record of successful product approval in the US, EU, Asia and pre-approval inspection success.
  • Deep experience interfacing with the FDA and other Health authorities.
  • Gene therapy experience a plus

Skills /Competencies

  •  Extensive knowledge and understanding of global regulatory requirements for CMC and GMO environment.
  • Demonstrated strategic thinking and problem-solving for CMC issues in the rapidly developing field of manufacturing gene therapy products.
  • Must be detail-oriented, possess good analytical testing knowledge, including problem-solving skills.
  • Must have excellent verbal and written communication skills, including strong interpersonal skills.
  • Ability to work independently with minimal supervision, and to take ownership and responsibility.
  • Ability to work cooperatively and influence, internal cross-functional teams including alliance partners
  • Results focused with the ability to perform under pressure and meet deadlines.
  • Ability to win respect and gain credibility within the company and with alliance partners.
  • Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities.
  • Alignment with Voyager’s Core Values
  • Travel Expectations: Travel both Domestic/International: 10-15%

 

Voyager Therapeutics is an Equal Opportunity Employer

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 engineering and optimization, manufacturing and dosing and delivery techniques. 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, tauopathies including Alzheimer’s disease and chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School.

Vice President, Regulatory Affairs

Reporting to the Senior Vice President of Regulatory Affairs and Quality Assurance, the Vice President of Regulatory Affairs will work with cross-functional teams to develop and implement regulatory strategy and summarize scientific data and submission packages to US and international regulatory agencies. This individual will be responsible for filing and supervising submission of multiple INDs and determining the strategy for multiple projects. Responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks and pathways for expedited development and timelines, serving as the regulatory representative on project teams, active involvement in writing/review of regulatory submissions,  interfacing with Health authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements and expedited approaches worldwide. The role requires a highly self-motivated and independent leader with demonstrated capabilities in the following areas: leading and managing BLA submissions, managing and mentoring staff, and working collaboratively with Senior Management, the Board of Directors and collaboration partners in a fast-paced, rapidly evolving gene therapy biotechnology environment.

Responsibilities

  • Provide innovative and proactive strategic regulatory leadership to project teams in early research and late stage clinical development for neurological diseases.
  • Work proactively in a cross-functional organization to partner with various R&D areas to design and execute an effective global regulatory strategy in alignment with the overall development plan and corporate goals.
  • Present the overall Voyager Regulatory strategy and work closely with Alliance partners in Regulatory Affairs and other disciplines to prepare and execute global development programs addressing the needs of each partner.
  • Lead and supervise the planning, preparation (including authoring where relevant) and delivery of routine and complex submissions throughout the product’s life cycle, including briefing documents, INDs, and various expedited designation requests including breakthrough, orphan drug, fast track and rare pediatric disease where appropriate.
  • Lead the planning, strategy, content and execution of BLA filing and follow through to approval
  • Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks.
  • Prepare the team and lead negotiations with FDA and other health agencies.
  • Provide regulatory due diligence as required.
  • Supervise and mentor direct reports who will be managing other programs.

Qualifications

  • Bachelor of Science Degree; PharmD, PhD or MD degree preferred.
  • At least 15 years of experience working in Regulatory Affairs; ideally 10 plus years in the biotech industry (gene therapy, monoclonal antibodies, vaccines, blood products, and/or cell products) including preferably experience in a small biotech company environment. Regulatory device strategy and experience, a plus.
  • Sound knowledge and experience in Regulatory Affairs and associated requirements, plus pharmaceutical industry experience in clinical trial and drug development work with a record of successful drug development through product approval in the US, EU, Asia.
  • Thorough knowledge of the drug development process including all expedited pathways and orphan drug designations, INDs, CTAs BLAs and MAAs.
  • Experience in interfacing with FDA and other Health authorities. Gene therapy experience a plus.

Skills /Competencies

  • Deep knowledge and understanding of global regulatory requirements and environment.
  • Demonstrated strategic thinking and implementation in overall drug development.
  • Must be able and willing to work diligently in a high-visibility, fast-paced environment and exhibit passion for patients with debilitating neurological diseases.
  • Must be detail-oriented, and possess good analytical and problem-solving skills.
  • Excellent verbal and written communication skills and strong interpersonal skills.
  • Ability to work independently with minimal supervision, and to take ownership and responsibility.
  • Ability to work cooperatively with teams including alliance partners and influence cross-functionally.
  • Results focused and able to work under pressure and to set and meet deadlines.
  • Confident with the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
  • Demonstrated ability for innovative and flexible strategies.
  • Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities.
  • Complete alignment with Voyager’s Core Values

 

Voyager Therapeutics is an Equal Opportunity Employer

 

 

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