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- Routinely support the plate-based ELISA QC team in ELISA method testing for Antibody Intermediate, troubleshooting, and method lifecycle activities.
- Perform testing of analytical assays including HPLC, CE, icIEF, ELISA, Electrophoresis, UV spectroscopic based methods, and compendial methods required for the release and stability testing of antibody intermediates and raw materials.
- Support Method Transfer and Method Qualification act activities by protocol execution, and protocol/report authorship
- Perform raw data review, trending and LIMs entry
- Work with QC and AD teams in the completion of critical method optimization activities
- Collaborate with Quality Assurance to review and approve documents associated with all quality control activities.
- Draft and review QC-analytical documents (SOPs, Protocols, Reports etc).
- Perform raw material sampling and testing
- Develop and maintain critical reagent inventory necessary to complete analytical quality control activities.
- BS in chemistry, biochemistry, bioanalytical Chemistry, or scientific related field with a minimum of 5 years of industry related experience and at least 2-3 years of ELISA plate-based assay testing experience.
- Demonstrated expertise in the testing of QC analytical assays for Antibody Intermediates, at various clinical or commercial stages.
- Extensive knowledge ELISA, and compendial methods.
- Demonstrated experience in a GMP Quality Control environment.
- Excellent interpersonal, organizational, written, and oral communication skills
- Excellent interdepartmental collaboration skills
- Demonstrated expertise with cGMP applicable to pharmaceutical settings and with method verification/validation concepts.
- Positive team oriented can-do-attitude.
- Ability to operate in a fast-paced laboratory environment and adapt to changing assignments.
Quality Control Contract Consultant - San Carlos, United States - Sutro Biopharma
Sutro Biopharma
San Carlos, United States
1 month ago