VP, Late-Stage & Commercial Biologics Development

Job description

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. 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. **How you might spend your days** - 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 - 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 - Championing the drafting and review of relevant CMC sections for global regulatory submissions (BLA, MAA, NDS, IND amendments), ensuring data integrity and scientific rigor - 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 - Developing, mentoring, and leading a high-performing team of scientists and engineers, fostering a culture of scientific excellence, cross-functional collaboration, and continuous improvement - Navigating complex interactions with global health authorities (FDA, EMA) regarding process validation, comparability protocols, and combination product regulations during milestone meetings - 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 - 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 **W****e’d love to hear from you if** - 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 - You have a proven track record in taking biologics from late-stage development through successful PPQ, BLA submission, and commercial approval - You have extensive experience managing tech transfers with CDMO partners, and person-in-plant (PIP) oversight - You have demonstrated the ability to build, inspire, and manage high-performing technical teams in a fast-paced biotech environment - Technical and regulatory understanding of combination products (pre-filled syringes, autoinjectors), including design controls and device integration, is not new to you **W****hat we offer** AbCellera’s hiring range for this role is currently under review. Your base salary will be commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. **A****bout AbCellera** ***Creating medicines is the most important work we can do.*** We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. **To apply** Please submit your application through our website and refer to **Job ID 23400** in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.