This position will support the biopharmaceutical research and development of scalable protein purification and characterization processes, scale up and transfer of processes to GMP facilities for clinical manufacturing, qualification of robust assays for routine and release testing of DS and DP, and preclinical toxicity studies.
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.
- Lead technology/process transfer to internal or external manufacturers.
- Develop robust and scalable protein purification processes for Ocugen biologics candidates.
- Execute process scale up at and/or transfer 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
- Work with Protein Science colleagues to seamlessly move development candidates from research to development stage.
- Write technical reports and present data/results to the project teams.
- Provide process and analytical SME input into the writing and review of regulatory submissions.
- Provide analytical SME input into due diligence initiatives as required.
- Collaborating with colleagues within Research and Development group to meet project goals.
- Maintain accurate, detailed and traceable notebook and documentations
- Management of projects with CROs and CMOs through recurrent project meetings and use of project management tools
What You Need to Apply:
- PhD., M.S. in biochemistry, analytical and biological sciences or relevant discipline with 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 with following instrumentations and procedures: FLPC, HPLC, CE, gel electrophoresis, spectroscopic based techniques (e.g., UV-Vis and Fluorescence), interaction based (EMSA, SPR, protein-protein, protein-DNA interaction methods), and cell culture-based bioassays. Work is expected to be done in a compliant manner according to SOPs and GMP guidelines when applicable.
- 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.
- Familiarity with wide range of biosensors, mass spectrometers and other characterization tools such as ITC, DSC, UV/Vis/IR spectroscopies, etc. is desirable
- Acute attention to detail and strong organizational and prioritization skills
- Superior communication skills
- Strong problem-solving skills
- Superior project management skills
- Ability to work independently and effectively as a team member with multidisciplinary project teams.