Senior Manager, Laboratory Operations Support
Teva Pharmaceuticals
5 days ago
On-site
West Chester, PA
Operations
Our Team, Your Impact
- Manage Quality Control (QC) Laboratory Operations and Stability programs, including GxP-compliant lab equipment/computerized systems ownership.
- Develop, improve, and execute stability programs for clinical product(s), supporting transition to Teva Global Operations upon commercialization.
- Oversee QC sample management (release, stability, in-process, reference standards, assay controls, etc.).
- Assess, improve, and maintain local/regional/global regulatory compliance (ICH, GMP, EPA, OSHA, DEA).
How You’ll Spend Your Day
Essential Duties & Responsibilities:
- Maintain up-to-date knowledge of regulations/standards (FDA, EMA, OSHA, DEA; WHO, ICH) and Teva policies.
- Oversee/manage computerized systems for QC testing (e.g., LIMS, EMPOWER) and instrument/network systems to ensure SDLC compliance from initiation through retirement (incl. modernization/continuous improvement).
- Oversee/manage stability studies: protocols, sampling, data review/trending, shelf-life (expiry/retest), temperature excursion assessments; serve as QC SME and SRC representative.
- Oversee/manage QC sample management: chain of custody and inventory/CTUs; internal/external transfers of release, in-process, stability, reference standard, and assay control materials.
- Support QC compliance: SOP/work instruction/protocol/report management; laboratory investigations; provide data for IND/BLA/MAA and regulatory information requests; advise on data integrity and GMP compliance; support OSHA/EHS compliance.
- Develop staff and growth in QC expertise.
Additional:
- Participate in budget planning (capital/annual ops) and execute purchases.
- Other assigned projects.
Qualifications / Education Requirements:
- Minimum BS in life sciences.
- 5–7+ years pharmaceutical industry experience in life sciences/biologics drug development.
- 2+ years supervisory experience.
- Knowledge of LIMS programming.
- Working knowledge of SDLC.
Benefits (explicitly stated):
- Generous annual leave, reward plans, flexible schedules (role dependent), access to tailored health support, community giving.
Application Instructions:
- Apply via Teva’s internal career site on Twist (for internal candidates).
- Manage Quality Control (QC) Laboratory Operations and Stability programs, including GxP-compliant lab equipment/computerized systems ownership.
- Develop, improve, and execute stability programs for clinical product(s), supporting transition to Teva Global Operations upon commercialization.
- Oversee QC sample management (release, stability, in-process, reference standards, assay controls, etc.).
- Assess, improve, and maintain local/regional/global regulatory compliance (ICH, GMP, EPA, OSHA, DEA).
How You’ll Spend Your Day
Essential Duties & Responsibilities:
- Maintain up-to-date knowledge of regulations/standards (FDA, EMA, OSHA, DEA; WHO, ICH) and Teva policies.
- Oversee/manage computerized systems for QC testing (e.g., LIMS, EMPOWER) and instrument/network systems to ensure SDLC compliance from initiation through retirement (incl. modernization/continuous improvement).
- Oversee/manage stability studies: protocols, sampling, data review/trending, shelf-life (expiry/retest), temperature excursion assessments; serve as QC SME and SRC representative.
- Oversee/manage QC sample management: chain of custody and inventory/CTUs; internal/external transfers of release, in-process, stability, reference standard, and assay control materials.
- Support QC compliance: SOP/work instruction/protocol/report management; laboratory investigations; provide data for IND/BLA/MAA and regulatory information requests; advise on data integrity and GMP compliance; support OSHA/EHS compliance.
- Develop staff and growth in QC expertise.
Additional:
- Participate in budget planning (capital/annual ops) and execute purchases.
- Other assigned projects.
Qualifications / Education Requirements:
- Minimum BS in life sciences.
- 5–7+ years pharmaceutical industry experience in life sciences/biologics drug development.
- 2+ years supervisory experience.
- Knowledge of LIMS programming.
- Working knowledge of SDLC.
Benefits (explicitly stated):
- Generous annual leave, reward plans, flexible schedules (role dependent), access to tailored health support, community giving.
Application Instructions:
- Apply via Teva’s internal career site on Twist (for internal candidates).