CMC / Manufacturing
Reports to Title:
Chief Manufacturing Officer
This position is responsible for managing Downstream process development and subsequent manufacturing of biological products at Contract Development and Manufacturing Organizations (CDMOs). Management of CDMOs and CROs is a critical aspect of the job and will include frequent visits to the contractors depending on the intensity of the ongoing activities. The role involves significant cross-functional collaboration with other functions, including but not limited to – R&D Discovery, Upstream, Analytical, Quality Assurance, Toxicology, Regulatory, Project Management, and Executive Leadership.
These may include, but are not limited to, the following; other duties may be assigned:
- Manage and support Downstream Process development.
- Manage and support Downstream manufacturing, Tech Transfer of Processes, Scale-up within or between CDMOs.
- Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CDMO/CRO, including tracking of technical risks, issues and decisions taken.
- Contribute to preparation and submission of CMC sections of regulatory submissions and updates (IND, BLA, and post marketing commitments)
- Design, manage and support Late-Stage BLA activities – Downstream Process Characterization Studies, Develop control strategies for process validation, PAI support.
- Author, review and/or approve Downstream and Virus Clearance related documents, including Batch Records, SOPs, Protocols, sampling plans, development reports, qualification/validation reports and other technical reports.
- Support process investigations and help determine root cause of excursions in clinical manufacturing.
- Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and procedures.
Education & Experience
- PhD in Biochemistry / Biology / Chemical Engineering, with 7+ years of biological process development and manufacturing experience with a strong record of achievement; or BS/MS degree and 10+ years of relevant experience.
- Proven hands-on experience with purification processes such as Chromatography columns, membrane filtration systems, Ultrafiltration/Diafiltration, Final Fill etc.
- Proven hands-on experience managing and executing Virus Clearance studies.
- Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
- Technical team management experience.
- Experience of setting up a process development lab is a plus.
- The position can be outside China location (may require travelling to China)
- Position may require working with biological and/or chemical hazards.