Oakland-Fremont-Pleasanton Metro Area, CA
To provide expertise to their designated QC group, and to accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.
Perform assays for their designated laboratory:
- Routine in-process, final product (antigens) protein chemistry testing for release of product
- Routine in-process, final product (antigens) microbiological testing for release of product
- Routine testing for release of Raw Materials
- Routine testing for release of Seed Stock
- Antigen Stability, reference/reagent qualification testing
- Seedstock Stability testing
- Cleaning and or Process Validation testing
- Analytical Method Validation testing
- Product/Method development testing
- Comply Site Environmental Health & Safety (EH&S) requirements
- Timely execution and completion of release and stability testing for all antigen product lines
- Timely execution and completion of stability testing for all seedstocks
- Timely execution and completion of testing for RMs
- Training in new assays within the required time
- No safety incidents or HSE related observations.
- Must have one or more assay testing experience in one of the main areas listed:
- Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
- Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
- Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
- Environmental/Utility/facility Monitoring testing such as Sampling of and testing of manufacturing water by membrane filtration, viable and non-viable particulate testing of facilities and utilities, viable (surface) monitoring of manufacturing facilities, personnel and biological hoods, moisture and oil content testing of compressed gases
- Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods
- Assay trouble shooting experience in their expert area
- Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color and appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
- Proficient in MS Word, MS PowerPoint and MS Excel software
- Must have good time management, effectively prioritizing tasks for completion
- Individual must work in an ethical manner and ensure employees follow company ethics and compliance guidelines.
Must meet the two (2) mission critical competencies:
- Customer Focus
- Technical Skills
- Requires at least 2 hours of standing at a time.
- Must be able to lift at least 35 lbs.
- A valid California driver s license required.
- Bachelor s degree in Biochemistry, Molecular Biology, Immunology
- At least 1-2 years experience in a regulated GMP testing laboratory