Biotherapeutics are fast becoming a highly effective form of therapy for treatment in oncology and other disease states. My client, an award winning, clinical stage Biotechnology company in the Cambridge region is currently seeking the expertise of a CMC Program Manager to be progressing their exciting portfolio of drug candidates to the clinic. The successful applicant shall have the opportunity to implement a manufacturing and scale up strategy, as well as managing the companies outsourced manufacturing and development activities.
CMC Program Manager Key Responsibilities:
The successful candidate will be expected to take on the day to day management and oversight of specific CMC programs, to include:
- Support ongoing outsourced manufacturing and development operations, with a particular focus on cGMP production of IMP for clinical trial supply
- Contractor evaluation, selection and management for product development activities
- Provide process development oversight and expertise for small molecule and solid phase peptide synthesis and scale-up.
- Oversee drug product formulation development and stability studies
- Review and approve MBRs, protocols, technical data output and status reports for formulation, analytical and manufacturing activities.
- Develop appropriate specifications and analytical methodology for the characterization and release of both drug substance and drug product
- To support regulatory submissions by providing appropriate CMC quality modules.
- Maintain and compile IMP product specification files
- Participation in cross-functional project team meetings, providing CMC representation and communication of key timelines and issues.
CMC Program Manager Key Responsibilities
- An appropriate chemistry degree/PhD or equivalent, with accompanying significant experience of working in a CMC function through a project focused role.
- Excellent knowledge of cGMP and related regulatory guidelines governing the manufacture of APIs and DP in the UK, EU & USA, with a particular focus on synthetic peptides and highly potent cytotoxic agents
- Proven track record of managing CDMOs to ensure optimal delivery to time, cost and quality
- Experienced in writing and reviewing Quality modules for regulatory submissions such as INDs and CTAs
- Strong interpersonal skills and experienced in presenting to senior management. Highly organised, able to prioritise work, work well under pressure and meet deadlines.
- Candidates with a synthetic and/or medicinal chemistry background will be favoured