Ref No.: 18-15863
Location: Emeryville, California
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 Grifols ethics and compliance guidelines.
Must meet the two (2) mission critical competencies:
Customer Focus
Technical Skills
Occupational Demands:
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.