Vice President/Senior Vice President, Manufacturing Sciences

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    "description": "<h2>Overview</h2>\n<p><strong><u>Who We Are:</u></strong></p>\n<p> </p>\n<p>At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, <strong>PROVENGE® (sipuleucel-T)</strong>, was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.</p>\n<p> </p>\n<p>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.</p>\n<p> </p>\n<p><strong><u>Core Values:</u></strong></p>\n<p><strong> </strong></p>\n<ul>\n <li><strong>Put Patients First: </strong>Every day is an opportunity to improve the lives of those living with cancer.</li>\n <li><strong>Act with Integrity: </strong>We commit to transparency, honesty, and always doing what’s right.</li>\n <li><strong>Build Trust: </strong>Trust is earned through candid, open communication and a collaborative approach.</li>\n <li><strong>Raise the Bar: </strong>We embrace continuous improvement and innovation, always striving to elevate our people.</li>\n <li><strong>Drive Results: </strong>We are accountable to each other and deliver success together.</li>\n</ul>\n<p><strong><u>Job Summary:</u></strong></p>\n<p>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.</p>\n<p>This role is responsible for leading and integrating:</p>\n<ul>\n <li>Analytical Sciences</li>\n <li>Antigen / Cellular Product Sciences</li>\n <li>Process Development & Process Sciences</li>\n <li>MSAT (Manufacturing Science & Technology) / Tech Transfer</li>\n <li>CMS (Contract Manufacturing Sciences)</li>\n</ul>\n<p><strong>NOTE:</strong><em> <strong>Title will be commensurate with experience, scope, and demonstrated leadership capability.</strong></em></p>\n<h2>Responsibilities</h2>\n<p> </p>\n<ul>\n <li><strong>Enterprise Manufacturing Sciences Leadership</strong>\n  <ul>\n   <li>Lead and integrate all Manufacturing Sciences functions across commercial and CMS programs.</li>\n   <li>Establish technical strategy, organizational structure, and operating model to support both internal pipeline and CDMO growth.</li>\n   <li>Ensure alignment of Analytical, Process Development, MSAT, and Antigen functions with corporate and manufacturing objectives.</li>\n  </ul></li>\n <li><strong>CMC & Technical Strategy</strong>\n  <ul>\n   <li>Own end‑to‑end CMC strategy for PROVENGE® lifecycle management and new programs.</li>\n   <li>Drive development and commercialization of next‑generation cell therapies, including:\n    <ul>\n     <li>mRNA-based platforms</li>\n     <li>CAR‑T and other engineered T-cell therapies</li>\n     <li>Dendritic cell (DC) therapies</li>\n     <li>Solid tumor applications</li>\n    </ul></li>\n   <li>Lead IND, BLA, and post‑approval technical strategy and regulatory interactions.</li>\n  </ul></li>\n <li><strong>Process Development & MSAT Execution</strong>\n  <ul>\n   <li>Oversee process development, scale‑up, validation, and tech transfer across internal and external manufacturing sites.</li>\n   <li>Ensure successful technology transfer into GMP manufacturing environments.</li>\n   <li>Drive continuous process improvement, robustness, and lifecycle optimization.</li>\n  </ul></li>\n <li><strong>Analytical & Product Sciences</strong>\n  <ul>\n   <li>Ensure development and execution of analytical strategies supporting release, stability, and comparability.</li>\n   <li>Maintain scientific leadership in cell therapy characterization, potency, and mechanism of action.</li>\n   <li>Support regulatory filings with high‑quality analytical packages.</li>\n  </ul></li>\n <li><strong>CMS / CDMO Manufacturing Sciences</strong>\n  <ul>\n   <li>Lead Manufacturing Sciences support for Dendreon’s CMS/CDMO business, including: \n    <ul>\n     <li>Client onboarding and technical diligence</li>\n     <li>Program feasibility assessments</li>\n     <li>Process development and tech transfer for external partners</li>\n     <li>Partner with BD and Operations to ensure technical readiness and successful execution of client programs</li>\n    </ul></li>\n  </ul></li>\n <li><strong>Cross‑Functional Leadership</strong>\n  <ul>\n   <li>Partner across Manufacturing, Quality, Regulatory, R&D, and Commercial functions.</li>\n   <li>Ensure alignment between scientific innovation and operational execution.</li>\n   <li>Serve as a key technical advisor to executive leadership.</li>\n  </ul></li>\n <li><strong>Regulatory & Compliance</strong>\n  <ul>\n   <li>Ensure all activities comply with cGMP and global regulatory requirements.</li>\n   <li>Lead responses to FDA and global regulatory inspections.</li>\n   <li>Maintain inspection readiness across all Manufacturing Sciences functions.</li>\n  </ul></li>\n <li><strong>People & Organizational Leadership</strong>\n  <ul>\n   <li>Build and lead high‑performing, multidisciplinary teams, including senior scientific leaders.</li>\n   <li>Develop organizational capabilities to support growth in advanced modalities and CDMO services.</li>\n   <li>Drive talent development, succession planning, and leadership readiness.</li>\n  </ul></li>\n</ul>\n<h2>Qualifications</h2>\n<p><strong>Education Requirements:</strong></p>\n<ul>\n <li>PhD in a relevant scientific discipline (e.g., Immunology, Cell Biology, Bioengineering, Biochemistry, or related field) or equivalent.</li>\n <li>15+ years (VP) / 20+ years (Sr. VP) in biopharma/biotech within cGMP environments.</li>\n <li>Deep experience in: \n  <ul>\n   <li>Cell therapy (required), including dendritic cell platforms</li>\n   <li>mRNA technologies</li>\n   <li>CAR‑T or engineered cell therapies</li>\n   <li>Solid tumor therapeutic applications</li>\n  </ul></li>\n <li>Demonstrated leadership in: \n  <ul>\n   <li>Process development and MSAT</li>\n   <li>Tech transfer into GMP manufacturing</li>\n   <li>IND/BLA filings and regulatory interactions</li>\n  </ul></li>\n <li>Proven track record of leading large, complex scientific organizations.</li>\n</ul>\n<p> </p>\n<p><strong><u>Working Conditions and Physical Requirements:</u></strong></p>\n<ul>\n <li>Travel as needed to manufacturing sites, partners, and regulatory interactions.</li>\n <li>Limited use of laboratory equipment, chemicals and biological materials.</li>\n <li>Ability to sit or stand for extended periods of time. </li>\n <li>Intermittent walking to gain access to work areas.</li>\n <li>Finger dexterity sufficient to use a computer and to complete paperwork activities</li>\n <li>Vision sufficient to use a computer, to read written materials and to complete paperwork activities.</li>\n <li>Hearing sufficient to communicate with individuals by telephone and in person.</li>\n <li>Ability to lift up to 25 pounds. Limited exposure to (2C – 8C); (-20C).</li>\n <li>Job performed in a lab, office, or utility (noisy) environment.</li>\n <li>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.</li>\n</ul>",
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