Manager Quality Control Analytical (Wednesday - Saturday)
$112,605–$168,907 year
On-site · Rockville, Maryland, United States
Job Summary
Manager, QC Analytical for a cell-therapy lab (Wed-Sat, 4x10h). Lead and oversee routine QC testing (flow cytometry, ELISA, PCR, cell-based assays) to ensure right‐first‐time analytical assay execution per cGMP/GDP and ALCOA+ data integrity. Responsible for laboratory operations, documentation, SOPs, audits, and training of analysts. Drive continuous improvement (LEAN/5S, standard work, deviation trend reviews), coordinate testing schedules, and collaborate with MSAT/AD, QA, Manufacturing, and Supply Chain to meet patient lot-release timelines. On-site leadership of a QC team with hands-on testing and instrument qualification; ensure readiness for internal/external inspections.
Required Qualifications
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline; advanced degree (MS/PhD) preferred
- At least 5 years' experience in pharmaceutical/biotech QC with emphasis on laboratory operations/management in a cGMP setting
- Hands-on experience with qualification and maintenance of key QC instruments and with lab informatics (LIMS/ELN/LES, instrument data systems); strong command of data integrity controls and computerized systems compliance
- Ability to design and deliver effective training; mentor analysts on safe, compliant, and efficient lab practices; cultivate a culture of quality and continuous improvement
- Excellent cross-functional collaboration with Manufacturing, QA, Supply Chain, Facilities, and EHS; capable of working on-site in a lab-based role
- Experience in preparing for audits/inspections and ensuring readiness
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