CMC Analytics Lead NBE
ProClinical is working with a clinical-stage Swiss Biotech company that is seeking a highly qualified Analytical Project Leader to support its CMC product development programs.
The candidate must possess a strong scientific background in Analytical Chemistry and must have drug development experience, preferably for monoclonal antibodies and within a CMC and QC setting. He/she must have a clear record of scientific accomplishments and ability to interact across functions within a dynamic matrix organization. Job description Analytical Project Leader (NBE)
- Lead and manage the analytical-related activities (release, stability, characterization, method development/transfer/validation, specification setting, etc) of Drug Products, APIs and raw materials
- Coordinate and/or perform the analytical-related activities to support Research and Manufacturing in house and at third parties
- Depending on project needs and growth, supervise and coach technician(s)
- Prepare, review and evaluate internal and third party scientific and technical protocols and reports as well as QC documents, including data consolidation and analysis
- Support Analytical Development and QC department in designing and monitoring the strategy, timelines and budget for assigned projects
- Support QA, Regulatory and Manufacturing departments in monitoring and evaluation of quality-related events (e.g. OOS, deviations, change controls)
- Ensure high quality analytical documentation for submission to Health Authorities
- Present data at international scientific conferences and publishing in scientific peer-reviewed journals
Skills and Requirements:
- Ph.D. or equivalent in Analytical Chemistry, Biochemistry, Biology or a related discipline applied to large molecules
- Analytical, QC or research related expertise (≥ 5 years) in the pharmaceutical/biotech field of New Biological Entities, preferably interacting within multi-disciplinary teams
- Successful industrial experience in physico-chemical methods, protein characterization and analytical project management for monoclonal antibodies
- Excellent knowledge and hand-on expertise on a wide variety of physicochemical and bioanalytical techniques (eg HPLC/UPLC, LCMS, SEC, electrophoresis, MALDI, IR, CD, ELISA, etc)
- Strong understanding of CMC analytical strategy for NBE (e.g. antibodies, therapeutic proteins and protein conjugates) at all clinical phases is an asset Analytical Project Leader (NBE)
- Experience in Regulatory Affairs and Quality applied to analytics (i.e. Ph.Eur./USP monographs and chapters, and ICH/FDA guidelines) is a plus
- High level of analytical troubleshooting and problem-solving skills
- Proactive and flexible team player, with ability to manage parallel activities, within different projects in a fast-paced environment
- Advanced communication (including scientific/technical) skills, both verbal and written
- Fluency in English; French and a third language are assets
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 +44 207 440 0671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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