B.S. degree in a science field required
1-2 relevant experience
Proficient in PCR based methods
The Associate Biochemist I performs quality sampling, testing, and data review for in process and bulk biopharmaceutical ingredients, finished biopharmaceutical products.
- Coordinate routine in-process biopharmaceutical materials, bulk biopharmaceutical ingredient, finished biopharmaceutical product and stability sample testing with testing labs.
- Conduct and documents routine compendial, chemistry, immunology and molecular bilology analytical testing for in-process, release and stability samples per SOP.
- Operate and maintain QC laboratory equipment/instrument in a cGMP-compliant manner.
- Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
- Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develops or revises laboratory SOPs as required.
- Assist in investigation and assay trouble shooting.
- Assist in critical reagent qualification/re-qualification, in compendia methods and other analytical method qualification/validation/transfer.
- Meet lab safety requirements.
- Trained as an Self Inspector Auditor and participate in >25% of department's Self Inspections.
You may apply for this position online by selecting the Apply now button.
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