This position will focus on, and be responsible for, the development of scalable protein purification processes, method development, qualification and release of products, for research and Tox studies, and for scale up and transfer of processes to GMP facilities for clinical manufacturing.
What You Will Be Primarily Responsible For:
- Design and develop downstream protein purification process and perform process optimization of large molecule/recombinant proteins from traditional cell culture, microbial fermentation, or new and unconventional bioprocesses.
- Execute process scale up and transfer at or to CMOs for cGMP production, perform PIP for production support and troubleshooting.
- Take lead role in CQA identification and extended molecular characterization of candidate drug and draft the BLA section for elucidation of structure. Work closely with CRO/CMO to ensure that analytical method SOPs are scientifically sound and aligned with industry best practices.
- Build internal analytical laboratories and expertise as appropriate. Analyze testing and characterization data. Oversee appropriate validation and analytical transfer activities in the appropriate GxP environment
What We Are Looking For:
- Ph.D., M.S. in biochemistry, analytical and biological sciences or relevant discipline
- Minimum 2-5 years (Ph.D.) or > 8 years (M.S.) of industrial protein purification/downstream process and / or analytical development experience in production of recombinant therapeutic proteins
- Experience in early stage development, and some experience of late-stage development &/or product approval
- Good understanding of GxP requirements and the demands of assay validation
- Hands-on experience with downstream process development, operations, process scale-up and technology transfer and associated analytical methods.