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Manager, Qc Analytical Jobs
Company | BioSpace |
Address | Baltimore, MD, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-07-25 |
Posted at | 10 months ago |
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
- Provides mentoring and Conducts Performance Management of direct reports.
- Responsible for generating management review metrics and KPIs.
- This position is also responsible for the day-to-day coordination and execution of in-process, release and stability testing at the Bayview site (EMOB).
- Regularly monitor QC reagent sample inventory.
- Accurately track and maintain outstanding QC data throughout the testing lifecycle and ensure that scheduled testing is initiated within the scheduled test period.
- Assists in creating and maintaining the unit budget.
- Manage the analysts / specialists who perform the activities related to biochemistry testing, method transfers and support execution of transfer protocols and reports.
- Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
- Performs managerial duties, as assigned, in support of QC operations such as resource management, routine data and investigation review.
- Monitor laboratory equipment and coordinate with other groups to ensure all equipment is maintained in a calibrated and qualified state.
- Works with the QC Sr. Manager and QC Director to ensure that QC operations are appropriately staffed, training is complete, and the operation meets both internal and external compliance (GMP) requirements.
- Demonstrated strong organizational and technical writing skills.
- Review current laboratory practice to identify alternative strategies or cost saving measures for laboratory improvement.
- Manage the Biochemistry Group operations in support of production by ensuring the timely execution of QC testing.
- Experience in assay method transfer, product release, and raw material testing and release.
- Must possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, Viral and Cell-based assays, SDS-PAGE, Western Blot, UV, sub-visible particle analysis, Bioassay.
- Ability to apply statistical analysis to QC monitoring and trending.
- Previous experience with vaccines and cell bank stability is preferred.
- Experience in laboratory control including sample accessioning and product testing.
- Experience in oversight of QC laboratory investigations including root cause analysis, OOS, and invalid assay investigation.
- Must be highly organized, detail oriented and able to manage multiple projects.
- Advanced knowledge of cGMPs, safety and data integrity.
- Previous LIMS experience is required, and LIMS administrator experience is highly desired.
- Must possess skills and knowledge of implementing and managing a compliant stability program.
- B.S. degree in microbiology, Biochemistry, or closely related scientific discipline with at least 10 years of relevant experience or M.S. degree with a minimum of 5-8 years of relevant experience.
- Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
- Solid communication and presentation skills required.
- Ideal candidate will have laboratory skills that include compendial testing such as appearance and fill volume, container closure integrity testing, and simple analytical instrumentation.
- At least 3 years prior supervisory experience in a GMP laboratory required.
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