CMC External Supply Manager
- Experience Level
Hobson Prior are looking for a CMC External Supply Manager for an exciting opportunity to join a top biotechnology organisation in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.
- You will assist with technology transfers to external parties & ensure ongoing compliant supply, maintaining timelines.
- Ensure secure compliant supply of critical materials for the organisation's portfolio (both internal & external GMP production).
- You will act as Technical/Supply Lead for post-tech transfer processes with Emphasis on fill/finish projects including Person in Plant and Batch record documentation review.
- Identification, documentation of potential risks and mitigations and monitoring of progress and manufacturing with emphasis on aseptic processes and fill/finish progress.
- Oversee activities focused on manufacturing support & trouble-shooting across all stages of manufacturing including aseptic processing and fill/finish for investigation of process failures, quality incidents, deviations, corrective/preventative action plans, and change controls
- Plan and optimise critical material supply across the portfolio.
- Develop systems and lead interactions with 3rd parties to achieve this
- Complete root cause investigations and work with multidisciplinary teams in developing and implementing solutions; identification of potential timeline & project challenges
- Oversee outsourced aseptic drug product manufacture i.e. fill-finish, providing guidance on best practices to improve aseptic processes and procedures.
- Review CMO batch documentation for all stages of manufacturing including aseptic drug product manufacture and provide company oversight of deviations etc.
- Any other assigned tasks.
- Demonstrable ability to work in and lead multi-disciplinary, multi-cultural teams and work effectively with partners.
- Bachelor's degree, (Masters/PhD/EngD) in either life sciences, biotechnology, chemical engineering, or related discipline.
- A minimum of 2-3 years' experience in aseptic processes manufacturing with emphasis on Fill/finish manufacturing process.
- Knowledge and experience of bioprocess development, scale-up and GMP manufacturing would be desirable (including large scale mammalian cell culture support).
- Experience in biopharmaceutical/biologics manufacturing and/or process development/scale-up.
- Experience of developing robust and scalable GMP compliant processes for either gene therapy, viral vectors, vaccines, or biological products; including knowledge spanning upstream; downstream with emphasis on fill/finish technologies.
- Experience of technology transfer, management of CRO's/CMOs and/or GMP manufacturing, providing technical expertise to assist troubleshooting issues, during technical transfer or routine production.
- Knowledge of quality management and regulatory requirements.
- Experience in pharmaceutical industry with a minimum of 2-3 years in GMP Manufacturing.
- Experience working in a cross-functional CMC team on a gene therapy, biopharmaceutical or vaccines project and demonstrable understanding of the technology and technical challenges.
- Experience of CMC development or regulatory affairs would be an advantage.
- Comprehensive understanding of the drug development process from development through to market.
- Ability to travel to work partners in Globally as the role requires.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.