Formulate and execute comprehensive Chemistry, Manufacturing, and Controls (CMC) strategies across all drug development stages to support pipeline progression and commercialization goals.
Oversee timelines, budgets, and resource allocation for process development, analytical method validation, tech transfer, and clinical/commercial batch manufacturing.
Direct the evaluation, selection, and oversight of external CMO/CDMO partners and vendors to ensure deliverables meet stringent project, quality, and regulatory standards.
Oversee the preparation and submission of CMC technical and regulatory documentation (e.g., IND/NDA/BLA modules), support patent/IP filings, and drive organizational knowledge management.
Lead CMC-related decision-making, collaborate closely with cross-functional stakeholders (R&D, QA, Regulatory Affairs), and ensure project milestones are achieved on schedule.
Build, mentor, and lead a high-performing CMC team, fostering a culture of technical excellence and handling key ad-hoc initiatives aligned with organizational goals.
Qualifications:
Bachelor's degree or above in Pharmacy, Pharmacology, Biotechnology, Life Sciences, Veterinary Medicine, or a related biopharmaceutical field. Ph.D degree preferred.
Minimum of 5 years of relevant experience in pharmaceutical R&D or CMC drug development; proven experience in large-molecule (biologics) veterinary or companion animal drug development is strongly preferred.
Demonstrated experience in building, mentoring, and leading scientific or technical R&D teams.
Strong foundational knowledge in immunology, biologics, or recombinant protein/antibody therapeutics is a plus.
In-depth understanding of CMC regulatory requirements, tech transfer workflows, and external CDMO/CMO governance.
