Vice President/Senior Vice President, Manufacturing Sciences
About The Position
At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease. If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation. The Vice President / Senior Vice President, Manufacturing Sciences, provides executive leadership for Dendreon’s Manufacturing Sciences organization across both commercial and CMS/CDMO operations. This role is responsible for end‑to‑end CMC strategy, technical execution, and organizational leadership across advanced therapy platforms. This role is responsible for leading and integrating: Analytical Sciences Antigen / Cellular Product Sciences Process Development & Process Sciences MSAT (Manufacturing Science & Technology) / Tech Transfer CMS (Contract Manufacturing Sciences) NOTE: Title will be commensurate with experience, scope, and demonstrated leadership capability.
Requirements
- PhD in a relevant scientific discipline (e.g., Immunology, Cell Biology, Bioengineering, Biochemistry, or related field) or equivalent.
- 15+ years (VP) / 20+ years (Sr. VP) in biopharma/biotech within cGMP environments.
- Deep experience in: Cell therapy (required), including dendritic cell platforms, mRNA technologies, CAR‑T or engineered cell therapies, Solid tumor therapeutic applications.
- Demonstrated leadership in: Process development and MSAT, Tech transfer into GMP manufacturing, IND/BLA filings and regulatory interactions.
- Proven track record of leading large, complex scientific organizations.
Responsibilities
- Lead and integrate all Manufacturing Sciences functions across commercial and CMS programs.
- Establish technical strategy, organizational structure, and operating model to support both internal pipeline and CDMO growth.
- Ensure alignment of Analytical, Process Development, MSAT, and Antigen functions with corporate and manufacturing objectives.
- Own end‑to‑end CMC strategy for PROVENGE® lifecycle management and new programs.
- Drive development and commercialization of next‑generation cell therapies, including: mRNA-based platforms, CAR‑T and other engineered T-cell therapies, Dendritic cell (DC) therapies, Solid tumor applications.
- Lead IND, BLA, and post‑approval technical strategy and regulatory interactions.
- Oversee process development, scale‑up, validation, and tech transfer across internal and external manufacturing sites.
- Ensure successful technology transfer into GMP manufacturing environments.
- Drive continuous process improvement, robustness, and lifecycle optimization.
- Ensure development and execution of analytical strategies supporting release, stability, and comparability.
- Maintain scientific leadership in cell therapy characterization, potency, and mechanism of action.
- Support regulatory filings with high‑quality analytical packages.
- Lead Manufacturing Sciences support for Dendreon’s CMS/CDMO business, including: Client onboarding and technical diligence, Program feasibility assessments, Process development and tech transfer for external partners.
- Partner with BD and Operations to ensure technical readiness and successful execution of client programs.
- Partner across Manufacturing, Quality, Regulatory, R&D, and Commercial functions.
- Ensure alignment between scientific innovation and operational execution.
- Serve as a key technical advisor to executive leadership.
- Ensure all activities comply with cGMP and global regulatory requirements.
- Lead responses to FDA and global regulatory inspections.
- Maintain inspection readiness across all Manufacturing Sciences functions.
- Build and lead high‑performing, multidisciplinary teams, including senior scientific leaders.
- Develop organizational capabilities to support growth in advanced modalities and CDMO services.
- Drive talent development, succession planning, and leadership readiness.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
