Associate Director, Operations - GMP

📋 Description

• Lead managers, supervisors, and scientific teams responsible for GMP laboratory operations, with
• Oversee GMP sample analysis supporting lot release, stability, characterization, and other
• Provide technical and operational oversight for validated and transferred analytical methods
• Evaluate assay performance and lead the resolution of complex scientific and operational issues.
• Lead or oversee laboratory investigations involving deviations, out-of-specification and
• Review and approve GMP laboratory documentation, which may include raw data, analytical data

🎯 Requirements

• Bachelor’s degree in scientific discipline, life sciences, operations, quality, or a related field.
• Eight (8) or more years working in a regulated laboratory, pharmaceutical, biotechnology, CDMO
• Six (6) or more years of people leadership, including responsibility for managers, supervisors, or
• Technical and operational leadership of GMP sample analysis supporting lot-release, stability
• Client support or internal scientific stakeholder management within a regulated environment.
• An equivalent combination of directly relevant education, training, and experience may be

🎁 Benefits

• Medical Insurance (HDHP with HSA; PPO)
• Dental Insurance
• Vision Insurance
• Flexible Spending Account (medical; dependent care)
• Short Term Disability | Long Term Disability Life Insurance
• Paid Time Off (4 weeks per year)