Job Description
Who We Are:
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.
Core Values:
- Put Patients First: Every day is an opportunity to improve the lives of those living with cancer.
- Act with Integrity: We commit to transparency, honesty, and always doing what’s right.
- Build Trust: Trust is earned through candid, open communication and a collaborative approach.
- Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people.
- Drive Results: We are accountable to each other and deliver success together.
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.
Responsibilities
- Enterprise Manufacturing Sciences Leadership
- 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.
- CMC & Technical Strategy
- 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.
- Process Development & MSAT Execution
- 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.
- Analytical & Product Sciences
- 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.
- CMS / CDMO Manufacturing Sciences
- 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
- Cross‑Functional Leadership
- 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.
- Regulatory & Compliance
- 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.
- People & Organizational Leadership
- 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.
Qualifications
Education 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.
Working Conditions and Physical Requirements:
- Travel as needed to manufacturing sites, partners, and regulatory interactions.
- Limited use of laboratory equipment, chemicals and biological materials.
- Ability to sit or stand for extended periods of time.
- Intermittent walking to gain access to work areas.
- Finger dexterity sufficient to use a computer and to complete paperwork activities
- Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
- Hearing sufficient to communicate with individuals by telephone and in person.
- Ability to lift up to 25 pounds. Limited exposure to (2C – 8C); (-20C).
- Job performed in a lab, office, or utility (noisy) environment.
- Must have the ability to work around laboratories, manufacturing areas and equipment. with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
