VP, Late-Stage & Commercial Biologics Development

<p>Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. </p> <p>We are looking for a creative, experienced and highly technical leader to shape the CMC strategy of our late-stage development programs through to commercialization. This is a rare opportunity to build and lead a late-stage Manufacturing Science and Technology (MSAT) function for high-impact antibody-based biologics. You will transition our lead asset from clinical manufacturing into a robust, commercially viable process and manage our late-stage CMC portfolio of combination products as our pipeline progresses through development.</p> <p><strong>How you might spend your days</strong></p> <ul> <li>Spearheading the overall late-stage process development strategy for upstream cell culture and downstream purification, starting with our lead antibody program and ensuring a seamless transition from Phase 2/3 clinical manufacturing to commercial readiness</li> <li>Overseeing the process characterization and PPQ studies and establishing robust control strategies and proven acceptable ranges (NORs/PARs) based on QbD principles and DoE statistical modeling</li> <li>Championing the drafting and review of relevant CMC sections for global regulatory submissions (BLA, MAA, NDS, IND amendments), ensuring data integrity and scientific rigor</li> <li>Steering technical process transfers, process scale-ups, and manufacturing troubleshooting activities across internal sites and our network of CDMOs and shaping technical workstreams to ensure cross-functional alignment on process interfaces</li> <li>Developing, mentoring, and leading a high-performing team of scientists and engineers, fostering a culture of scientific excellence, cross-functional collaboration, and continuous improvement</li> <li>Navigating complex interactions with global health authorities (FDA, EMA) regarding process validation, comparability protocols, and combination product regulations during milestone meetings</li> <li>Supporting drug product process characterization and the technical development and integration of the combination products, including human factors engineering interfaces and adherence to 21 CFR Part 4 design control requirements</li> <li>Partnering tightly with Quality Assurance, Regulatory Affairs, Supply Chain, Clinical and Commercial teams to ensure manufacturing strategies align with clinical timelines and program risk management strategies</li> </ul> <p><strong>W</strong><strong>e’d love to hear from you if</strong></p> <ul> <li>You have a post-secondary degree in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, or a related field and 18-20+ years of related experience in biopharmaceutical Process Development, MSAT, or CMC, with a minimum of 8 years in a leadership role and a heavy emphasis on mammalian cell culture and development of antibody therapeutics </li> <li>You have a proven track record in taking biologics from late-stage development through successful PPQ, BLA submission, and commercial approval</li> <li>You have extensive experience managing tech transfers with CDMO partners, and person-in-plant (PIP) oversight</li> <li>You have demonstrated the ability to build, inspire, and manage high-performing technical teams in a fast-paced biotech environment</li> <li>Technical and regulatory understanding of combination products (pre-filled syringes, autoinjectors), including design controls and device integration, is not new to you</li> </ul> <p><strong>W</strong><strong>hat w