Quality Control Manager - Cell Therapies
Vertex Pharmaceuticals
3 days ago
On-site
Cambridge, MA
Operations
Key Duties and Responsibilities:
- Manage laboratory program(s)/processes (assay readiness, training, sample management, data review and reporting) and serve as QC contact/representation for Quality Events.
- Coordinate and facilitate laboratory activities to meet on-time commitments.
- Ensure lab personnel have appropriate training.
- Assist in troubleshooting analytical methods and/or equipment.
- Author, review, and/or approve data and SOPs.
- Monitor, track, and publish lab metrics.
- Ensure laboratory records adhere to cGMP/GDP expectations.
- Lead sub-teams focused on continuous improvement.
- Lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence (as required).
- Provide guidance to reports; coach and develop reports.
- Serve as T1D Cell QC representative in cross-functional teams and/or with outside vendors.
Knowledge and Skills:
- Strong knowledge of US/EU cGMP regulations/guidance; some regulatory agency inspection experience.
- Strong knowledge of analytical methodologies: flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin; applying/interpretation of GMP requirements.
- Effective verbal and written communication.
- Ability to prioritize across projects, meet timelines with attention to detail.
Education and Experience:
- Bachelor’s degree in science or related discipline required; 8 years of pharmaceutical/biopharmaceutical industry experience (or equivalent combination of education/experience).
Pay Range:
- $117,800 - $176,800
Flex Designation:
- On-Site (five days per week on-site with ad hoc flexibility).
- Manage laboratory program(s)/processes (assay readiness, training, sample management, data review and reporting) and serve as QC contact/representation for Quality Events.
- Coordinate and facilitate laboratory activities to meet on-time commitments.
- Ensure lab personnel have appropriate training.
- Assist in troubleshooting analytical methods and/or equipment.
- Author, review, and/or approve data and SOPs.
- Monitor, track, and publish lab metrics.
- Ensure laboratory records adhere to cGMP/GDP expectations.
- Lead sub-teams focused on continuous improvement.
- Lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence (as required).
- Provide guidance to reports; coach and develop reports.
- Serve as T1D Cell QC representative in cross-functional teams and/or with outside vendors.
Knowledge and Skills:
- Strong knowledge of US/EU cGMP regulations/guidance; some regulatory agency inspection experience.
- Strong knowledge of analytical methodologies: flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin; applying/interpretation of GMP requirements.
- Effective verbal and written communication.
- Ability to prioritize across projects, meet timelines with attention to detail.
Education and Experience:
- Bachelor’s degree in science or related discipline required; 8 years of pharmaceutical/biopharmaceutical industry experience (or equivalent combination of education/experience).
Pay Range:
- $117,800 - $176,800
Flex Designation:
- On-Site (five days per week on-site with ad hoc flexibility).