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.
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
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.
Proactively plan, organize, and manage complex Executive schedules/calendars using Microsoft Outlook, including prioritizing and managing conflicting responsibilities in a fast-paced environment.
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
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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.
Qualifications and Experience:
Additional Experience Desired:
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
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.
Voyager Therapeutics is an Equal Opportunity Employer
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To apply or learn more about career opportunities at Voyager Therapeutics, please email firstname.lastname@example.org.
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