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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

Clinical Data Manager ( Contract/ Part-Time )

Voyager is seeking a Contract, Part -Time Consultant for 20-25 hours per week. The ideal candidate will join us on-site a minimum of 2 days per week.

The successful candidate will provide operational leadership and take full accountability for the execution of all Data Management related duties to support the development of Voyager clinical programs with high quality and adherence to Regulatory and Industry guidelines. This role will report to the Associate Director, Clinical Operations.

Responsibilities

  • Manage the complete EDC system development process from initial set-up through database lock including; UAT Plan and testing of clinical study databases along with development of edit check specifications and manual data listings as required.
  • Supervise, review and manage, the surveillance of CRO and third party vendor performance activities regarding the quality and timeliness of the deliverables and ensure database is ready for lock. Provide justification for and perform direct negotiations with CRO. Observe and recommend opportunities for improvement and optimization.
  • Develop and maintain SOP’s and related control documentation.
  • Design or review creation and maintenance of all essential data management documents; including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Review Guidelines, Data Entry Guidelines, Data Transfer specifications and laboratory data handling.
  • Ensure clinical databases and external data files are designed in a consistent format to produce dataset that are conducive to analysis. Coordinate deliverables such a DMB reports, IND Annuals, safety listings. Coordinate data cuts/transfers and conduct data reviews.
  • Maintain all data management internal files, ensuring preparedness for regulatory inspections.
  • Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
  • Functional Lead on project teams, study teams, development teams including multi-disciplinary interactions by participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables.

Requirements

  • Advanced degree or BA/BS in Technical or Life Sciences (Biology, Chemistry, Biotech, or Computer Science).
  • Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered.
  • Minimum: 7 – 10 years experience in Data Management for the pharmaceutical/biotechnology industry.
  • Experience as lead DM of a Phase I-III studies required; ability to be primary DM representative with little oversight required.
  • Strong knowledge and understanding of regulations and industry adopted data standard: CDIC, SDTM, CDASH.
  • Biostatistics background helpful but not required
  • Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR Part 11 and their application to Data Management practice.
  • Knowledge of and experience with MedDRA and WHO Drug data dictionaries.
  • Skill and knowledge in ad hoc data reporting, data review listings and metrics reporting.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors with positive data management approach.
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Advanced level proficiency with relational databases (EDC) systems and technologies (e.g. RAVE, Medrio, Phase Forward InForm, Oracle Clinical) and CDISC data standards are desirable.
  • Advanced computer proficiency in MS Office products (e.g. Microsoft Project, Excel, MS Word).
  • Ability to thrive in a fast-paced, entrepreneurial environment with high-performiing colleagues.
  • Self-motivated, critical thinking and problem solving skills.
  • Possesses strong written and verbal communication skills.
  • Able to travel to off-site meetings or training seminars as needed.

 

To apply, email careers@voyagertherapeutics.com

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The Vice President, Corporate Counsel will report to the Chief Financial Officer, and will provide leadership, management and guidance on legal matters and risk management for Voyager. This key role will coordinate legal advice in the areas including business development/ licensing, corporate law, contracts, SEC, litigation, data privacy, regulatory/clinical law and intellectual property. This executive will have significant impact on the development of corporate programs, policies and actions, by advising on legal ramifications, requirements and legal actions critical to effective strategic business decisions. The VP, Corporate Counsel will work in close partnership with the CFO, and will frequently interact with CEO, executive leadership team and our Board of Directors. This newly created role will provide hands-on expertise as well as coordinate with specialized outside counsel as needed.

Responsibilities:

  • Manages current team of Contracts Manager, plus multiple external counsel relationships
  • Provide advice and direction to managers and employees on operational issues including, but not limited to: IP protection, legal risk, and regulatory compliance.
  • Analyze, facilitate, negotiate and draft complex transactions including but not limited to licensing agreements, sponsored research agreements, etc.
  • Oversees all contract work, including, but not limited to, drafting/reviewing/negotiating services agreements, vendor contracts, licensing agreements, leases, clinical trial agreements , sponsored research contracts, consulting agreements, and non-disclosure agreements
  • Responsible for training the organization on contracts practices, negotiation, compliance, intellectual property protection, and other contracts, legal and compliance topics.
  • Regulatory work, including researching and interpreting federal and state laws, regulations, interpretive guidelines, advisory opinions and court cases for corporate and healthcare issues.
  • Develop, review and/or revise corporate policies and procedures.
  • Act as corporate secretary, including documenting board and committee minutes and maintaining governance and contracts recordkeeping systems.
  • Review inquiries/complaints from state and federal administrative, regulatory and other governmental or accreditation agencies, perform necessary research of the law and internal practices, coordinate, draft, and negotiate the response and/or reviewing responses to the government agency.
  • Perform due diligence related activities in assigned areas in connection with business development activities.
  • Draft and present training programs on legal topics.

Qualifications:

  • JD from an accredited law school, with membership in good standing of the bar in the Commonwealth of Massachusetts.
  • 10+ years of legal experience, with at least 5 in biotech/life sciences industry
  • Skilled communicator who can concisely describe and articulate key legal issues and options.
  • Strong organizational skills, with demonstrated ability to manage a broad and varied workload and prioritize effectively
  • Strong results-orientation, with excellent strategic thinking abilities and demonstrated ability to advise on current needs and emerging considerations.
  • Experienced in selecting and managing outside counsel
  • Experience in training, educating and advising executives, employees, key business partners and others on key legal topics required
  • Ability to work independently and as a team player

* Voyager is not accepting agencies, search firms or external candidates for this role*

To apply, email careers@voyagertherapeutics.com

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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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 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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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