Responsibilities
- Manage QC Chemistry or Microbiology laboratory operations; ensure GMP, protocol, and safety compliance.
- Manage QC personnel: organize/prioritize daily tasks, training, and performance reviews.
- Oversee day-to-day laboratory operations.
- Write/implement changes to controlled documents (SOPs, software specifications, methods).
- Follow technology changes; recommend and implement new technologies as appropriate.
- Lead/coordinate projects, initiatives, and investigations; solve complex issues with in-depth assessment.
- Select appropriate analytical methods/techniques/evaluation criteria using sound judgment.
- Provide QC Chemistry/Microbiology expertise and counsel.
- Lead training and career coaching for QC staff and manage Team Leaders, Chemists, Microbiologists, and Technicians.
- Perform data review, process trending, procedural updates, and support qualification protocol writing.
- Interact with senior management/executives; participate in regulatory audits as required.
- Direct team activities to meet schedule, budget, and resource requirements.
Required/Preferred Qualifications & Skills
- Excellent communication/interpersonal skills; effective teamwork.
- Critical/creative thinking; independent problem-solving; strong organizational/planning skills.
- In-depth GMP, pharmacopoeia, and regulatory knowledge for pharmaceutical testing/validation.
- Proven leadership and problem-solving; current industry knowledge; strong analytical and computer skills.
- Education/Experience: 8+ years + BS; or 6+ years + MS; or 2+ years + PhD; QC experience in a highly regulated manufacturing environment.
- Preferred: prior people management; biopharmaceutical/pharmaceutical experience.
Compensation/Benefits
- Salary range: $143,225.00β$185,350.00. May be eligible for discretionary bonus/long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Current employees/contractors: apply via the Internal Career Opportunities portal in Workday.