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.

Job Summary:

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 endtoend 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.

• 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 endtoend CMC strategy for PROVENGE® lifecycle management and new programs.
  • Drive development and commercialization of nextgeneration cell therapies, including:
    • mRNA-based platforms
    • CART and other engineered T-cell therapies
    • Dendritic cell (DC) therapies
    • Solid tumor applications
  • Lead IND, BLA, and postapproval technical strategy and regulatory interactions.
• Process Development & MSAT Execution
  • Oversee process development, scaleup, 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 highquality 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
• CrossFunctional 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 highperforming, 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.

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
  • CART 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.

PI284600319