Our client, a gene therapy biotech, spin-off of Genethon, is searching for his/her CMC Operational Manager.
Within a high growth, fast paced small organization, the CMC Analytical Scientist is responsible for providing analytical expertise and leadership in the development and manufacturing of recombinant- adeno associated virus vectors (rAAV).
ln this position, he/ she will manage the analytical development activities for the company’s programs through coordination of contract research organization (CROs) and contract development and manufacturing organization (CDMOs) to support all stages of the drug development, from preclinical to commercial.
This includes methods development/ re-evaluation/ optimization, troubleshooting of methodologies as requested, methods transfer and validation. The ability to be productive and successful in an intense work environment is critical.
Key activities :
- Work with the CMC Operational Manager and the CDMOs /CROs to define the Critical Quality Attributes (CQAs), conduct comprehensive rounds of testing on starting materials, raw materials, intermediates and final products,
- Propose new analytical methods or refine existing ones, in response to changing requirements during the pharmaceutical development.
- Oversee the analytical development for the pipeline products. Conduct transfer and validation for the methods’ official use,
- Oversee the stability studies for drug substance and drug product. Evaluate and monitor the data,
- Manage the company’s inventory for Reference Materials. Coordinate the manufacturing and characterization of new reference material as well as the stability studies and shelf-life extension of the existing one.
- Provide the CMC supportive data/documentation to prepare regulatory packages (IND/ IMPD/ MAA/ BLA). Review the CMC sections.
- Proactively maintain knowledge in CMC analytical sciences. Investigate advanced technology and research opportunities,
- Advanced degree in Biology Sciences, Molecular Biology is a plus (MD, PharmaD, PhD) with 5 to 10 years’ experience in analytics for Biological Products (Biotech, BioPharma, CRO, CDMO).
- Expertise in relevant analytical techniques, including but not limited to, qPCR/ ddPCR, RT-PCR, bioassays spectroscopy, chromatography (SEC, HPLC), electrophoresis, immunoassays, microbiology testing.
- Good comprehension of cGMP/USP/Ph. Eur and applicable FDA and EMA regulations.