Quality Control Manager - Cell Therapies
Vertex Pharmaceuticals
11 days ago
On-site
Boston, MA
Operations
Key Duties And Responsibilities:
- Oversee QC analytical functions supporting in-process, release, and stability testing and reporting; ensure efficient, cGMP-compliant operations.
- Manage lab programs/processes (assay readiness, training, sample management, data review/reporting); act as QC point of contact for Quality Events and triage.
- Coordinate/facilitate lab activities to meet on-time commitments.
- Ensure lab personnel training is appropriate.
- Troubleshoot analytical methods and/or equipment.
- Author, review, and/or approve data and SOPs.
- Monitor, track, and publish lab metrics.
- Ensure lab records meet cGMP/GDP expectations.
- Lead sub-teams toward continuous improvement.
- Lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence.
- Provide guidance, coach, and develop direct reports.
- Serve as T1D Cell QC representative in cross-functional teams and with outside vendors.
Knowledge And Skills (Required):
- Strong US/EU cGMP knowledge; some experience with regulatory inspections.
- Strong analytical methods knowledge (flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin) and applying/interpreting GMP requirements.
- Effective verbal and written communication.
- Ability to prioritize multiple projects, meet timelines, and maintain attention to detail.
Education And Experience:
- Bachelor’s degree in science or related discipline required; 8 years’ experience in pharmaceutical/biopharmaceutical industry (or equivalent).
Pay/Compensation (as stated):
- $117,800–$176,800; eligible for annual bonus and annual equity awards.
Benefits (as stated):
- Medical/dental/vision; paid time off; educational assistance (student loan repayment); commuting subsidy; 401(k) and other benefits.
Work Location:
- On-site; five days per week on-site with ad hoc flexibility.
- Oversee QC analytical functions supporting in-process, release, and stability testing and reporting; ensure efficient, cGMP-compliant operations.
- Manage lab programs/processes (assay readiness, training, sample management, data review/reporting); act as QC point of contact for Quality Events and triage.
- Coordinate/facilitate lab activities to meet on-time commitments.
- Ensure lab personnel training is appropriate.
- Troubleshoot analytical methods and/or equipment.
- Author, review, and/or approve data and SOPs.
- Monitor, track, and publish lab metrics.
- Ensure lab records meet cGMP/GDP expectations.
- Lead sub-teams toward continuous improvement.
- Lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence.
- Provide guidance, coach, and develop direct reports.
- Serve as T1D Cell QC representative in cross-functional teams and with outside vendors.
Knowledge And Skills (Required):
- Strong US/EU cGMP knowledge; some experience with regulatory inspections.
- Strong analytical methods knowledge (flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin) and applying/interpreting GMP requirements.
- Effective verbal and written communication.
- Ability to prioritize multiple projects, meet timelines, and maintain attention to detail.
Education And Experience:
- Bachelor’s degree in science or related discipline required; 8 years’ experience in pharmaceutical/biopharmaceutical industry (or equivalent).
Pay/Compensation (as stated):
- $117,800–$176,800; eligible for annual bonus and annual equity awards.
Benefits (as stated):
- Medical/dental/vision; paid time off; educational assistance (student loan repayment); commuting subsidy; 401(k) and other benefits.
Work Location:
- On-site; five days per week on-site with ad hoc flexibility.