Associate Director, Microbiology
Teva Pharmaceuticals
5 days ago
On-site
West Chester, PA
Operations
Our Team, Your Impact
This position manages Quality Control operations in a GxP-compliant laboratory, focusing on microbiological testing and corresponding investigations to support pre-clinical and clinical product manufacture and transition of testing programs to Teva Global Operations (TGO) upon commercialization.
How You’ll Spend Your Day
Essential Duties & Responsibilities:
- Maintain up-to-date knowledge and compliance with relevant regulations and standards (e.g., FDA, EMA, MHRA, OSHA, DEA; WHO/ICH) and Teva policies.
- Create, revise, manage, and implement SOPs, work instructions, protocols, and reports (including Corporate Gap Assessments and periodic reviews).
- Supervise a small team and multiple simultaneous projects.
- Oversee QC microbiology lab operations, including:
- Implement microbiological tests (e.g., TOC, conductivity, endotoxin, bioburden) for routine and non-routine testing.
- Manage QC microbiology investigations and support related micro investigations.
- Develop and execute specialty study strategies (e.g., Hold Time, Low Endotoxin recovery).
- Support review/approval of documentation as needed.
- Manage method suitability activities.
- Initiate and recommend improved methods and continuous improvement initiatives.
- Manage equipment/instruments (qualification, implementation, maintenance, retirement) per SDLC and regulations.
- Develop staff to maintain/increase expertise and improve departmental productivity.
Additional Responsibilities:
- Participate in budget planning (capital and annual) and execute purchases.
- Other duties as assigned.
Qualifications / Education Requirements:
- BS/MS/PhD with 10+ years’ microbiology experience in the pharmaceutical industry.
- 7+ years’ laboratory management experience.
- 4+ years’ supervisory experience.
- Strong microbiology background (regulations, GMPs, manufacturing processes).
Benefits:
- Generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, meaningful ways to give back.
Application Instructions:
- Apply through the internal career site on Twist (for internal candidates).
This position manages Quality Control operations in a GxP-compliant laboratory, focusing on microbiological testing and corresponding investigations to support pre-clinical and clinical product manufacture and transition of testing programs to Teva Global Operations (TGO) upon commercialization.
How You’ll Spend Your Day
Essential Duties & Responsibilities:
- Maintain up-to-date knowledge and compliance with relevant regulations and standards (e.g., FDA, EMA, MHRA, OSHA, DEA; WHO/ICH) and Teva policies.
- Create, revise, manage, and implement SOPs, work instructions, protocols, and reports (including Corporate Gap Assessments and periodic reviews).
- Supervise a small team and multiple simultaneous projects.
- Oversee QC microbiology lab operations, including:
- Implement microbiological tests (e.g., TOC, conductivity, endotoxin, bioburden) for routine and non-routine testing.
- Manage QC microbiology investigations and support related micro investigations.
- Develop and execute specialty study strategies (e.g., Hold Time, Low Endotoxin recovery).
- Support review/approval of documentation as needed.
- Manage method suitability activities.
- Initiate and recommend improved methods and continuous improvement initiatives.
- Manage equipment/instruments (qualification, implementation, maintenance, retirement) per SDLC and regulations.
- Develop staff to maintain/increase expertise and improve departmental productivity.
Additional Responsibilities:
- Participate in budget planning (capital and annual) and execute purchases.
- Other duties as assigned.
Qualifications / Education Requirements:
- BS/MS/PhD with 10+ years’ microbiology experience in the pharmaceutical industry.
- 7+ years’ laboratory management experience.
- 4+ years’ supervisory experience.
- Strong microbiology background (regulations, GMPs, manufacturing processes).
Benefits:
- Generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, meaningful ways to give back.
Application Instructions:
- Apply through the internal career site on Twist (for internal candidates).