Senior Director, CMC Operations
Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com
This role works within the Technical Operations function at Voyager and is responsible for Internal and External Manufacturing and Supply Operations, and CMC project management across Voyager’s internal and partner programs. This role leads the internal non-GMP manufacturing team for material production for IND enabling studies, collaborates with other Technical Operation functional areas to develop CMC project plans, and provide external manufacturing support to our contract development and manufacturing (CDMO) partners. This role is also responsible to set the tech transfer polciies and protocols and oversee tech transfers to CDMOs.
The role reports into the Head of Technical Operations and is a hybrid role with primary office being Lexington, MA.
Position Specific Responsibilities:
- Provide CMC project leadership across internal and partner programs
- Lead the internal manufacturing team to provide material for IND-enabling studies in a timely manner
- Collaborate with process development to develop tech transfer protocols and documents to support TT at CDMOs
- Lead the development of CMC project plans for new and/or advancing programs , with input from other Technical Operations functions (process development, analytical development, and Quality)
- Provide CMC representation for program team meetings and update the team on resources, cost, timeline tasks, and alternative options to accomplish desired schedule as needed
- Provide leadership for the interaction of the CMC cross-functional SMEs between Voyager and the CDMOs
- Work closely with CDMOs used to produce GMP material, using site visits and frequent communication with CDMO team members to update status of CMC project
- Setup supply chain across critical raw materials, packaging, labeling, shipping and distribution to the clinic working closely with facilities team
- Work closely with finance team to manage operations within approved budget
- Work closely with alliance manager for partner programs to setup and manage CMC working group, and provide project management leadership
- 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 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
- Support key vendor and supplier evaluations, working closely with quality, 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
Specialized Knowledge & Skills:
- Demonstrated experience with cross functional leadership
- Developing high performance teams
- Strong knowledge of GMPs and CMC regulatory requirements
- BS\MS\PhD degree in scientific field (Biology, Chemistry, Engineering) with 15+ 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 CDMO search, selection and management
- 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.
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