qPCR experience is required.
Job Summary/Operations Involvement:
- Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.
- Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols.
Specific Biochemistry Focus Areas:
- Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing.
- Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation.
The introduction of new equipment and technology to improve sustainability and compliance is expected.
Job Function and description
- 40-50% Testing execution, participate in training analysts, trouble shooting of methods
- 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
- 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
