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 ).
- 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.
- 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).