CMC specialist with
GMP biologics manufacturing expertise
The Requirement
This role is required to direct, supervise and oversee GMP manufacturing biologics drug products (including ADCs) to support clinical development. Candidate must have strong knowledge and experience of CMC requirements and compliance aspects for biologics including process development (to support upstream and downstream biologics manufacturing, including cell culture and purification), manufacturing and testing methodologies and documentation (specifications, batch records etc). Familiarity and experience with ICH guidelines and FDA/HSA regulations to ensure compliance with global manufacturing standards is necessary. Prior experience in preparation/review of CMC dossiers for submission to US FDA, HSA and other health authorities is essential.
The Requirements
- Advanced degree in life sciences, biotechnology, pharmaceutical sciences or chemical engineering
- 8-10 years of experience in GMP manufacturing environment.
- Prior experience in outsourcing and supervision of contract development and manufacturing organisations (CDMO) for the development, scale-up, and manufacturing of biologic drug products including monoclonal antibodies, recombinant proteins, antibody-drug conjugates etc
- Oversight of release and stability testing activities, GMP storage and distribution of biologic products to support clinical trials in various locations
- Authoring and review of CMC dossiers for regulatory submission
- Collaboration with cross functional development teams to ensure compliance and timely and successful product delivery
- Excellent verbal and written communication skills and experience in working in agile team environments
