Title: Associate Director/ Director CMC Operations
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
Forty Seven Inc. is seeking a highly motivated biopharma/biotech industry professional with experience in coordinating CMC development plans and CDMO manufacturing. The position will be responsible for managing budgets/invoices and assist in contract negotiation. Candidates will have the ability to partner with the CMC leads and multiple cross-functional team members to execute integrated project plans. The position will also be responsible for ensuring active communication of status, risk, risk management, and escalation of issue to stakeholders. This position will report to the VP, Technical Development and Manufacturing.
These may include, but are not limited to, the following; other duties may be assigned
- Facilitates the CMC project-planning process with input from technical lead and team members; drives execution and monitors progress.
- Leads the preparation of CMC project budgets, facilitates appropriate review, and maintains forecasts.
- Maintains high level and detailed timelines of the CMC project plan and ensures that the functional timelines are aligned with overall development program timelines.
- Prepares CMC project progress updates, identifies issues associated with project timeline and/or budget.
- Regularly interacts with functional areas beyond CMC, such as Regulatory, Quality, Supply Chain and Clinical for project timeline alignment
- Coordinate with CMOs on contract/SOW negotiation; co-leads meetings; follows up on action items; organizes timely technical review of external meeting minutes.
- Prepares and maintains CMC project dashboards; assists CMC leads with compilation of data packages to support business development, licensing, and partnership.
- Actively works to foster an environment of effective and collaborative working relationships amongst CMC team and external partners
Education & Experience:
- University degree and a minimum of 12 years related experience or Ph.D. with a minimum 6 years relevant experience. Broad pharmaceutical lifecycle management experience desirable. BLA experience is highly desired.
- Ability to lead through example and to establish an environment fostering effective and collaborative working relationships.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Proficient in managing budget, timeline and alignment.
- Proven personnel management skills.
- Strong oral, written and listening skills.
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international.