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Biopharma Operations Manager
2 weeks ago
Job Overview:
This role is responsible for managing laboratory operations, overseeing daily activities, and ensuring quality and timeliness of projects. The Associate Group Leader will provide support to the Biopharma department by providing management and direction to a group of laboratory staff.
- Main Responsibilities:
- Management of laboratory staff
- Allocation, scheduling, and management of laboratory resources
- Preparation, review, and approval of study protocols, project status reports, final study reports, and other technical documents
- Designing experimental studies and participating in technical troubleshooting
- Reviewing data for technical quality and compliance to protocols, methods, and SOPs
- Assisting in client and regulatory authority audits
- Coordinating and prioritizing project activities with internal functional groups and support functions
Requirements:
- Bachelor's degree in a relevant area (e.g., chemistry, biochemistry)
- Previous experience in laboratory management or a related field (comparable to 5+ years) or equivalent combination of education, training, and experience
- Leadership responsibility for at least 1 year
- Management experience in the pharmaceutical, biotech, or analytical contract laboratory industries
- Knowledge of GMP requirements, client SOPs, ICH guidelines, EP, and USP requirements, EMA, and FDA guidance