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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

Principal Research Scientist/Associate Director, Tau/Neuroscience

Voyager is seeking a highly motivated neuroscientist and leader with substantial experience and demonstrated success with early stage drug discovery for Alzheimer’s Disease and tau protein-related neurodegeneration to provide biology leadership for advancing our AAV gene therapy tau program. 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

  • Biology leadership for the tau program.
  • Development of preclinical program plans in research, communication of changes and progress, and sharing of expertise with others.
  • Management of a small team of scientists and research associates.
  • Attendance of relevant scientific conferences to network with academia and industry, and to stay current in relevant research.

 Requirements:

  • Ph.D. in Neuroscience with 8-12 years industry experience.
  • Minimum of 5 years experience in a supervisory role in industry
  • Extensive experience with tau and neurodegeneration
  • Significant experience with drug discovery and development for neurological disorders, including neurodegenerative diseases
  • In-depth familiarity with target validation and lead identification and optimization using molecular, cellular, and in vivo methodologies
  • Outstanding problem-solving skills
  • Ability to be highly productive in a fluid and fast-paced work environment
  • Strong publication record and experience in presenting research
  • Ability to independently analyze and present data to scientific team

Strongly Preferred

  • Experience with antibody drug discovery and development for neurodegenerative diseases
  • Experience on cross-functional therapeutic program team
  • Experience within a start-up or small biotech environment
To apply, email careers@voyagertherapeutics.com

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Director, Research Vector Production (Scientific Leader)

Voyager is seeking a highly motivated scientist and leader with substantial experience and demonstrated success with rAAV vector production to contribute to our research team.

The Director of Research Vector Production will lead a team in the 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 supervise the upstream and downstream processing of small- to medium-scale research-grade batches of rAAV vectors using multiple production systems,and will oversee in-process testing and process development, 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. The candidate will interact extensively with the research-stage program teams and manage the production schedule and capacities to meet vector needs for both programs and novel capsid discovery work.  Additionally, this individual will be responsible for the authorship of protocols, reports, operating procedures, and other documents. 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.

Job Responsibilities:

  • Manage a vector production group focused on production of 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
  • Work closely with program teams and novel capsid discovery teams to understand and prioritize vector needs and timelines, and effectively communicate production schedule and plan to the teams
  • Streamline vector production processes and ensure timely delivery of vectors to the program teams
  • 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 complications during upstream and downstream processes and QC
  • Optimize multiple cell culture platforms for rAAV vector production including mammalian and insect cells
  • May participate in lab work related to vector production and QC
  • Ensure adequate use of electronic tracking system for documenting and tracking vector production requests, status and inventory
  • Review and approve production and QC records

Requirements:

  • M.S. or Ph.D. in a biological science or chemical engineering (vectorology or bioprocessing focus) with minimum of 5 years of subsequent research, vector manufacturing, or process development experience
  • Minimum 3 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
  • Minimum 2 years of experience within a start-up or small biotech environment
  • Excellent organizational skills and attention to detail
  • Strong commitment to accountability for self and departmental staff 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 complex manufacturing strategies and find timely solutions
  • Must have strong written and oral communication skills

Strongly Preferred:

  • Experience and knowledge of biologics and/or gene therapy vector manufacturing
  • Experience in managing a vector core group
To apply, email careers@voyagertherapeutics.com

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Director, Informatics / IT

Voyager is seeking a customer-centric, Information Technology/ Informatics professional to lead and improve   business processes through the design, implementation and growth of our information architecture.  This individual will own and manage infrastructure and resources to meet organizational needs and will be responsible for working cross-functionally with all departments to identify long-term, scalable, practical solutions for research and operations as the organization grows.   He/she will act as a close business partner, to establish close partnerships with colleagues accross multiple disciplines to translate business needs into state-of-the-art informatics solutions.

Leadership

  • Execute with strong Project Leadership and influence communications utilizing business acumen, with data, analytical skills and relationship-building capabilities to inspire the organization around common goals, vision and values for IT and informatics
  • Define, implement and own data architecture achieving company-wide strategy for data storage, processing, analysis, mining and security
  • Serve as champion for global data management, governance, quality and vendor relationships across the company
  • Establish an architecture and a collection of integrated decision-support applications and databases, providing the company easy access to corporate data.
  • Grow the breadth and depth of department expertise to meet short and long-term corporate objectives

Information Technology

  • Oversee contingency planning and IT security and compliance by establishing controls and processes in support of data security, PHI, SOX and other relevant regulatory requirements
  • Manage vendors, consultants and overall budget for data management and IT
  • Lead the planning and estimation of IT & Informatics projects such as ELN, LIMS, mobile data migration, Quality/CMC workflow, security initiative:, document rights, multi-factor
  • Regularly and effectively communicate with key project stakeholders, keeping them advised of project progress and generally making IT activities transparent to stakeholders
  • Set strategy for IT infrastructure and software capabilities for current and future organizational needs
  • Maintain ongoing knowledge of industry trends and ability to utilize that knowledge to determine the most efficient ways to meet business needs
  • Communicate strategy to scientific personnel, operations and senior management to ensure alignment
  • Measures availability, performance, capacity, and utilization of IT and Informatics services
  • Detects, monitors, reports, manages, escalates and ultimately prevents service failures and/or degradations.
  • Takes ownership of security across the board and lead IT related compliance for the Company.
  • Collaborate with others to facilitate business needs definition, workflow design and integration of scientific processes and technology into effective IT solutions

Research Informatics

  • Work with R&D team to develop and implement computational biology strategy, goals and evolution of the team
  • Implement and maintain key research systems, including ELN, LIMS and Results Management
  • Grow and effectively maintain cloud-based computing environment
  • Develop and implement data integration and analytics strategy

Minimum requirements:

  • Advanced degree in life sciences, plus minimum 10-15 years of relevant experience working in IT within Biotech/Bio Pharma industries
  • Minimum 5-7 years of experience managing and implementing informatics and IT solutions in a start-up, biotech environment
  • Ability to identify impediments to complex business and research issues and provide timely and cost-effective solutions
  • Solid scientific/ technical knowledge to be able to successfully ensure project scope and fit technology for applications, networking and information systems strategic roadmap and execution of all Informatics solutions and IT services
  • Experience with evaluating, implementing and managing scientific data management platforms, cloud computing (AWS), Egnyte, Benchling, document control/electronic lab notebook software, on-site storage solutions and IT vendor services
  • Prior experience and record of accomplishment leading cross functional teams and delivering on schedule in a start-up biotech environment
  • Prior experience in successfully implementing, utilizing and leveraging outsourcing strategies
  • Practical understanding of relational database design and development
  • Demonstrated understanding of the software development lifecycle
  • Ability to adapt to increasing scope and complexity of work brought on by growth/change and helps others manage through change
  • Strong written, oral and public speaking communication skills.

 

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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Principal Research Associate / Scientist – Biology

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.

Requirements

  • BS./ 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 Scientist/Engineer, Process Development (Upstream Focus)

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 Process Development Group with a focus on upstream production.  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
  • Lead as Voyager point person for and maintain various external relationships with partners, vendors and CMOs/CROs
  • Highly engaged/ involved, leading 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

 

Ref# 18TO-CM002

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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Director/Senior Director, Antibody Platform (Scientific Leader)

Voyager is seeking a highly motivated scientist and leader with extensive experience in therapeutic antibody discovery and development to contribute to our research team and build the Antibody Platform at the company.

This individual will build and lead a platform effort on antibody discovery and engineering including but not limited to AAV-vectorized antibodies, integrating both internal and external resources.  Incumbent will also play an important role in business development opportunities and ongoing and future partnerships. The candidate should have substantial working familiarity and demonstrated success with state-of-the-art approaches for generating, selecting, humanizing and optimizing human antibodies and antibody fragments against targets of interest. These approaches include tools and systems such as transgenic mouse strains that produce human antibodies, high throughput hybridoma and B-cell cloning from immunized animals and from human samples, and display technologies for affinity maturation. Responsibilities will include the development of a strategy and implementation of plans for rapid advancement of the vectorized antibody platform, and oversight of a group responsible for activities that include hybridoma screening, antibody gene cloning and sequencing, recombinant antibody expression, antibody humanization, lead antibody identification, antibody optimization including affinity maturation, and antibody characterization. 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.

Requirements

  • PhD in Immunology, Cell Biology, Molecular Biology, Biochemistry or related fields and with at least 10+ years industry experience, or equivalent
  • Track record of leading successful antibody drug discovery and candidate selection for transition to development
  • In-depth knowledge and expertise with designing workflows for hybridoma screening and antibody gene isolation and characterization
  • Substantial working experience with antibody affinity maturation and humanization methods
  • Outstanding problem-solving skills
  • Ability to be highly productive in a fluid, fast-paced, team-oriented work environment
  • Proven experience with leading and managing a small group, with minimum of 7 years in a leadership and supervisory role in industry
  • Experience on cross-functional therapeutic program team
  • Outstanding organizational skills
  • Extensive experience working with CROs
  • Strong publication record and experience in presenting research

Strongly Preferred

  • Experience with drug discovery for neurodegenerative diseases
  • Experience within a start-up or small biotech environment

 

To apply, email careers@voyagertherapeutics.com

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Senior Research Associate, Neuroscience

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 Alzheimer’s Disease.

Voyager is seeking a highly motivated biologist 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 vitro and in vivo experimental 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 extensive prior hands-on in with techniques such as cell culture, in vitro assay development and execution, CNS tissue preparation, qRT-PCR, western, and ELISA. This position is located in Cambridge, MA and reports to a Principal Research Scientist.

Requirements:

  • B.S. or M.S. in Biology or related discipline
  • Outstanding problem-solving skills
  • Ability to be highly productive in a fluid and fast-paced work environment
  • At least 5 years of hands-on experience with in vitro and in vivo
  • Experience with design, documentation and execution of experiments
  • Ability to independently analyze and present data to scientific team

Strongly Preferred:

  • Working knowledge of AAV, cell culture and cellular biology
  • Familiarity with molecular and cell biology methods
  • Experience with drug discovery for neurodegenerative diseases
  • Experience on cross-functional therapeutic program team
  • Experience within a start-up or small biotech environment
To apply, email careers@voyagertherapeutics.com

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Director, Program & Alliance Management ( Late Stage )

The Director of Program Management will play a critical role in advancing Voyager’s emerging portfolio of life-changing gene therapies for severe neurological disease.   Serving as a focal point for cross-functional collaboration, this role will bridge strategy at the corporate, portfolio, and program level to operational priorities, effective processes, and efficient execution of drug development.  This individual demonstrates a high degree of business acumen,  a highly collaborative, trust-building style, and laser-focus on driving results through effective communication, decision making, and follow-through. This position is located in Cambridge, Massachusetts.

Key Responsibilities

  • Serve as the central point of operational leadership and cross-functional coordination for Voyager’s exciting Parkinson’s Disease Program as it advances into a registration enabling Ph2/3 clinical trials
  • Drive development, evolution and execution of aggressive global development plans, including deliverables, timelines, budgets, contingency plans and stakeholder engagement
  • Partner effectively and fluidly with functional leaders and team-representatives to ensure effective program-function communication, alignment, and decision making
  • Participate as core team member in due diligence, collaboration definition, and operationalization of ex-US collaboration.
  • Ensure strong integration, relationship building, and operational execution with external Device / Delivery partners
  • Drive and instill continuous process improvement initiatives/mindset across the organization to build capability, streamline processes and improve communication and flow of information up/down across the business.
  • Develop and implement effective operational processes for tracking and reporting progress in an integrated way across timelines, resources, and key milestones.
  • Create and monitor (KPI’s) key performance indicators at the portfolio and program level, highlighting progress, risks, and mitigation options.
  • Assist with the formation and leadership of various sub teams; (Research, CMC, Pre- Clinical, Commercial) within program team umbrella to ensure alignment and efficient delivery against overall program goals
  • Foster high-performing team cultures with clear expectations, effective use of time, clear accountability, and efficient follow-up.
  • Play a highly visible and impactful role in linking Corporate Resource Planning with portfolio strategy, operational planning, and resource prioritization trade-offs
  • Partner with leaders in Commercial and Medical Affairs to ensure development and delivery of an innovative “Go-to-Market” strategy that sets the stage for a highly-successful launch Prepare and deliver presentation materials for Portfolio Management Committee, Management Team, and Board of Director meetings

 

Minimum Qualifications

  • Bachelor of Science or degree in Lifesciences required, MBA or equivalent preferred.
  • Minimum of 10 years work experience in Program/ Alliance leadership/ drug development, consulting, project or operational management roles
  • Skilled communicator, equally comfortable with written and verbal interaction across business, clinical and scientific content
  • Ability to think creatively, integrate different perspectives, and build alignment towards a shared sense of purpose.
  • Significant experience in biotech/life sciences and medical device industries highly preferred.
  • Experience working in a fast-paced, growing (start- up) environment.
  • Strong independent and Team oriented contributor
  • Highly organized and disciplined in approach.
  • Demonstrated ability to roll-up sleeves and work in a collaborative, scalable fashion.

 

 

To apply, email careers@voyagertherapeutics.com

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Associate Director, Program & Alliance Management ( Early Stage )

The Associate Director of Program Management will play a critical role in advancing Voyager’s emerging portfolio of life-changing gene therapies for severe neurological disease.   Serving as a focal point for cross-functional and scientific collaboration, this role will bridge strategy at the corporate, portfolio, and program level to operational priorities, effective processes, and efficient execution of drug development.  This individual demonstrates a high degree of business and scientific acumen, a highly collaborative, trust-building style, and laser-focus on driving results through effective communication, decision making, and follow-through. This position is located in Cambridge, MA.

Key Responsibilities

  • Drive advancement of Voyager’s Early Stage Pipeline Programs and help accelerate differentiation and translation of platform capabilities into new programs and partnerships
  • Lead multiple early-stage Program Teams in developing appropriately ambitious development plans, including articulation of Target and Minimum Product Profiles, timelines, budgets, and overall value proposition
  • Partner effectively with senior leaders in Research, Clinical Development, Technical Operations, and Regulatory to ensure effective program-functional communication and alignment
  • Work closely with Commercial, Business Development, and Investor Relations to translate scientific and clinical potential into compelling product profile concepts supporting engagement with investors and potential partners.
  • Play a highly visible and impactful role in linking R&D Resource Planning with portfolio strategy, operational planning, and resource prioritization trade-offs
  • Serve as Alliance Manager for partnered programs, ensuring seamless communication and effective discussions/decisions as needed
  • Develop and implement effective operational processes for tracking and reporting progress in an integrated way across timelines, resources, and key milestones.
  • Create and monitor (KPI’s) key performance indicators at the portfolio and program level, highlighting progress, risks, and mitigation options.
  • Assist with the formation and leadership of various sub teams; (Research, CMC, Pre- Clinical, Commercial) within program team umbrella to ensure alignment and efficient delivery against overall program goals
  • Foster high-performing team cultures with clear expectations, effective use of time, clear accountability, and efficient follow-up.
  • Prepare and deliver presentation materials for Portfolio Management Committee, Management Team, and Board of Director meetings

Minimum Qualifications

  • Bachelor of Science or degree in Lifesciences required, Master’s/ Ph.D preferred.
  • Minimum of 10 years work experience in Program/ Alliance leadership/ drug development, consulting, project or operational management roles
  • Skilled communicator, equally comfortable with written and verbal interaction across business, clinical and scientific content
  • Ability to think creatively, integrate different perspectives, and build alignment towards a shared sense of purpose.
  • Significant experience in biotech/life sciences and medical device industries highly preferred.
  • Experience working in a fast-paced, growing (start- up) environment.
  • Strong independent and Team oriented contributor
  • Highly organized and disciplined in approach.
  • Demonstrated ability to roll-up sleeves and work in a collaborative, scalable fashion.

 

To apply, email careers@voyagertherapeutics.com

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Vice President, Regulatory Affairs

Reporting to the Senior Vice President of Regulatory Affairs, the Vice President of Regulatory Affairs will work closely with Regulatory staff and 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 including broad-based applications including PD, ALS, Huntington’s disease, Friedreich’s ataxia, Alzheimer’s disease, chronic pain and vectorized antibodies. Responsibilities include actively leading 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 or supervisor 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 incumbent will require demonstrated leadership capabilities in the following areas; lead and manage BLA submissions, self-motivated/ independent, manage and mentor staff, work collaboratively with Senior Management, as needed, and when called upon, collaboration partners in a fast-paced evolving gene therapy biotechnology environment. This position is located in Cambridge, MA.

Responsibilities

 

  • Lead and assist the SVP of Regulatory to drive project teams in early research and late stage clinical development for neurological diseases.
  • Partner with cross-functional organizations; Clinical Development and 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, supervise and develop staff in 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, regenerative medicine advanced therapy, 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.

Minimum 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). 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 manage and develop Regulatory staff members who are supervised and 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

 

 

 

To apply, email careers@voyagertherapeutics.com

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Research Associate, Process Development (Downstream/Formulation 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 a focus on downstream purification and formulation.  The qualified candidate will assist with and/or individually carry out chromatographic purifications, various filtration operations, formulation studies for Voyager’s various rAAV products, and conduct stability studies.  Work activities will also include following / preparing protocols, SOPs and final study reports, and general lab operations.  The ability to independently organize, design, carryout and analyze data and report the results of their work in a concise and well documented manner are important aspects of the position. This position is located in Cambridge, MA.

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 capsid purification using column chromatography / Akta protein purification systems
  • Complete concentrations and diafiltrations 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
  • Maintain and update databases for reagents
  • Execute studies for rAAV product formulation development
  • Carry out stability studies for DS/DP/IP pools
  • Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents
  • Assist with the production of nonclinical materials at Voyager

Qualifications

  •  Bachelor’s degree in chemical engineering, biology, biochemistry, chemistry, biotechnology, or related fields
  • A minimum of 1 year of downstream purification and/or formulation 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 quickly learn and work in a fast-paced, start-up environment
  • Previous experience working with the downstream purification or formulation of protein biologics, vaccines, or rAAV viral vectors desired

 

Ref # 18TOCM006

To apply, email careers@voyagertherapeutics.com

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Voyager is seeking a highly motivated scientist to contribute to the Analytical Development group. The qualified candidate will participate in development, qualification, and transfer of new state-of-the-art analytical methods to be used for characterization and release of Voyager’s products. This role is currently an individual contributor but may expand to having direct reports in the future. This position is located in Cambridge, MA.

Responsibilities

  • 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
  • Develop cell-based bioassays for AAV viral vector products
  • Revise, review, and author assay standard operating procedures
  • Act as subject matter expert in providing analysis and data interpretation both internally and externally with CMO’s/CRO’s
  • Manage and participate in tech transfer of analytical methods to CMO’s/CRO’s
  • 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.
  • Candidate should be detail-oriented, self-motivated, goal driven, and should be able to work effectively on teams to progress projects. The candidate’s ability to take initiative and manage projects is highly desirable.
  • 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
  • Developing cell-based bioassays for gene therapy viral vectors
  • Knowledge and interest in laboratory and equipment automation
  • Industrial experience and an understanding of the biologics drug development process is desired.
To apply, email careers@voyagertherapeutics.com

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Voyager is seeking a highly motivated Research Associate for a position within the analytical development group. The qualified candidate will maintain adherent cell culture and plate cells for bioassays using aseptic conditions. The candidate will also perform analysis of process development and pre-clinical grade materials. After product testing, the candidate will be responsible for data analysis as well as reporting of data. Responsibilities include, but not limited to the following. This position is located in Cambridge, MA.

Responsbilities

  • Maintain cell culture and plate cells for bioassays under aseptic conditions
  • Independently, conduct assays on in-process and final products
  • Perform routine assays on a weekly basis to determine product quality
  • Analyze data and record results into ELN/LIMS in a timely manner
  • Formulation and testing of buffers and materials needed for routine assays
  • Perform both qualitative and quantitative analysis of proteins (ELISA, Western blot, silver stain/PAGE) and DNA (qPCR, agarose gel electrophoresis)

Qualifications

  • BS in Biochemistry/Biology/Chemistry/Virology or a related field
  • 1-3 years of relevant experience in (Biotech/Biopharma) industry
  • Experience testing AAV or similar gene therapy viral vectors highly preferred
  • Experience with aseptic adherent mammalian cell culture maintenance is important for qualifying for this position
  • Strong desire to learn multiple techniques and willingness to provide support as required
  • Significant attention to detail and accuracy in following protocols
  • Demonstrated ability to be highly productive in a fluid, fast-paced and team work environment
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.

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

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