Director, QC & Analytical Operations (Gene Therapy)
3M HEALTHCARE
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Benefits offered by this job
Job summary
Genezen in Fishers, Indiana, seeks a senior leader to manage the Analytical and Microbiological Quality Control Laboratories, providing scientific and technical leadership for QC activities and supporting Analytical Development in method qualification/validation.
The role includes overseeing the environmental monitoring program, EM trending, and LIMS development, with responsibility for environmental monitoring, instrument systems, data integrity, and timely testing of clinical-grade
Qualifications
- BS in a scientific/technical discipline - Essential
- MS in a scientific/technical discipline - Preferred
- 7+ years of experience in a QC leadership position within the biological industry - Essential
- Proven leadership in bioanalytical methods (development/validation/transfer) including ELISA, PCR/qPCR, ddPCR, cell-based assays, flow cytometry - Essential
- Familiarity with viral vector release assays - Preferred
- 3+ years of cGXP experience - Preferred
Responsibilities
- Lead all QC activities in analytical and microbiological labs
- Provide scientific and technical expertise for method qualification/validation
- Oversee environmental monitoring program and EM trending
- Manage lab equipment systems, data integrity, and performance qualifications
- Support tech transfer of bioassays to cGMP QC testing labs
- Represent QC in client meetings and regulatory inspections
Skills
Education
Tools
Job description
Genezen in Fishers, Indiana, seeks a senior leader to manage the Analytical and Microbiological Quality Control Laboratories, providing scientific and technical leadership for QC activities and supporting Analytical Development in method qualification/validation.
The role includes overseeing the environmental monitoring program, EM trending, and LIMS development, with responsibility for environmental monitoring, instrument systems, data integrity, and timely testing of clinical-grade
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