Manufacturing Operations Lead
2 days ago
About the Role
The Manufacturing Operations Lead will be responsible for leading investigations in a biotech/pharma manufacturing environment. This is a hybrid position, and the role requires strong technical knowledge of fill/finish operations.
Responsibilities
- Manage deviation investigations, including establishing investigation teams and developing comprehensive compliant documentation.
- Drive improvements to the investigation process and present findings to regulatory inspectors and internal auditors.
- Coordinate and lead cross-functional teams through complex investigations.
- Project management of the investigations end to end.
- Present complex topics to large and small groups at various levels.
Qualifications
- Bachelor's Degree in Science or Engineering with 5+ years of experience in a biotech/pharma manufacturing role.
- Detailed technical understanding of fill/finish operations and compliance regulations.
- Excellent technical writing and presentation skills.
- Ability to manage multiple priorities in a fast-paced environment.
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