CMC Project Lead (mAbs/Biologics/Proteins)
Our client, a global leading biotechnology company with a strong presence in the biosimilars field, is currently seeking to hire a CMC Project Lead - Biologics/Biosimilars to be based in Switzerland.
Key job responsibilities for this role include:
- Manage CMC product development for products going into and through clinical development stages
- Manage projects from development to IMP administration for a given clinical phase and ensure detailed timelines are established/respected through negotiation with project stakeholders and work package owners
- Coordinate with functional leads/line managers (R&D groups, PD, MFG, Quality, IMP) and external consultants to ensure timely execution of work packages
- Act as point of contact for CMOs/CROs as well as for external consultants
- Manage all aspects of project management, process technology transfer and scale up procedures (if appropriate) to CMOs (DS and DP)
- Assemble RFP in collaboration with functional leads, CMO identification, technical/quality agreements in collaboration with QA
- Co-manage work-package conceptualization, timelines, execution, closeout (up to finalized report) alongside CMO representative
The ideal candidate will be able to demonstrate the following minimum criteria:
- MSc/PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline
- Relevant biologics R&D and CMC experience in an industrial setting
- Knowledge of current GMP guidelines, familiarity with regulatory authority submissions
- (IMPD/IND/BLA), quality and technical agreement drafting (CMO)
- Experience (hands on or theoretical) in process/analytical technology transfer and process scale up/validation
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 (0)207 4400 671 or upload your CV on our website www.proclinical.jobs . Full job description available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.