Vice President/Senior Vice President, Manufacturing Sciences

Vice President / Senior Vice President, Manufacturing Sciences

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)

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.