Head of CMC
發佈於： 2026/8/24
Taipei Northern Taiwan
Permanent
生命科學、醫療保健、製藥
Responsibilities:
Qualifications:
- 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.