Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research. With clinical development activities in the United States, China, Europe, and Australia, and operations in those geographies as well as Hong Kong, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.
The Director of CMC Biologics will oversee efforts to develop and manufacture drug substance and drug product and to track clinical drug supply. This position reports directly into the Vice President of CMC and will have two direct reports in separate locations.
- Act as a supporting contact to oversee production activities at CMOs and provide technical support and troubleshooting.
- Establish PFS device development plan and mange on time execution.
- Collaborate with other functions at Connects to develop and implement specifications for drug substance and drug product specifications and if needed, collaborate with QA and other functions to manage out of specifications, deviations and investigations.
- Collaborate with Clinical Operations to ensure that drug supplies are available on-time for support of clinical studies.
- Author and/or review batch records, change controls, and other technical documents.
- Oversee the development and validation of analytical methods according to ICH guidelines to ensure effective characterization and release of clinical batches.
- Design and oversee formulation development and stability studies for drug substance and drug product for multiple compounds.
- Develop BLA strategy, manage selection of commercial launch site, negotiate contract, and manage on time execution.
- Collaborate with QA, Regulatory Affairs and other functions towards timely generation of regulatory documents.
- Propose and manage US CMC group budget. Manage all contracts and follow the invoices and execution.
- Manage US CMC team to reach the group goals of the CMC function
- Support a collaborative, global CMC team in technical and managerial processes.
- MS/PhD in Biology, Bioengineering, Biochemistry, or Pharmaceutical related fields is required.
Qualifications And Requirements
- 10+ years of related industry experience in drug substance and/or drug product development, production, and analysis.
- An in-depth knowledge and drug development experience in biologics, preferably monoclonal antibodies, is strongly desired, from early to BLA stage development.
- Familiarity with protein purification, protein analytical and characterization techniques.
- Familiarity and working knowledge of GMP/ICH regulations required, with experience of commercial product development preferred.
- Prior PFS experience is a plus.
- Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.
- Team oriented professional with excellent organizational, communication, leadership and problem-solving abilities.
- Previous management experience in leading a team of people to deliver an objective
- Experience managing multiple remote employees.
- Ability to deal with time demands, incomplete information or unexpected events
- Excellent attention to detail
- Excellent time management skills with proven ability to manage multiple tasks and associated deadlines
- Ability to work in a geographical and culturally diverse environment, across multiple time zones.