A super exciting Bay Area CDMO in the Richmond,CA is currently looking to add a Sr. Scientist, Analytical Development to the team! This position will be a 12 month contract to hire!
Sr. Scientist, Analytical Development will lead the development, optimization, and transfer of analytical methods to support our process development and quality control.
- Establish and oversee a high performing team capable of supporting analytical development activities with an emphasis on physicochemical, biological, and compendial methods.
- Evaluate and implement new technologies within the Analytical Development group, with a particular emphasis on separation techniques (HPLC/UPLC and CE), and binding based assays.
- Write/review SOPs, test method protocols, assay development and qualification plans/reports.
- Write/review analytical sections of IND/IMPD filings.
- Provide mentorship and training of junior level scientists in the laboratory.
- Coordinate activities of outside resources such as consultants and vendors.
- Represent analytical development group in project meeting
- Ph.D. in Biochemistry, Analytical Chemistry or a related discipline with a minimum of 2 years of relevant industry work experience or a Master's or Bachelor's degree with a minimum of 6 years of relevant industry experience.
- Experience in developing and qualifying/validating analytical methods to support product development and QC batch release, for biologic products is a PLUS
- Strong background in (UPLC/HPLC, CE) and bioassays (ELISA, qPCR)
- Understanding of regulatory requirements for early-stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.
- Working experience in biologic formulation development is a plus.
If you are interested in learning more about this opportunity, please Apply Now!