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.
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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.
* Voyager is not accepting agencies, search firms or external candidates for this role*To apply, email firstname.lastname@example.org
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.
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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.
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.
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.
Voyager Therapeutics is an Equal Opportunity EmployerTo apply, email firstname.lastname@example.org
To apply or learn more about career opportunities at Voyager Therapeutics, please email email@example.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