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Biologics Operations Leader
3 weeks ago
Job Summary
We are seeking a highly skilled and experienced Biologics Operations Leader to join our team. The ideal candidate will have a proven track record of leading new product introductions, managing teams, and ensuring compliance with regulatory requirements.
About the Role
- Lead and support the team in activities such as compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation, and processing to achieve operational goals.
- Coach and mentor the manufacturing team to enhance effectiveness through clear communication.
- Foster a culture of contamination control and adherence to aseptic best practices.
- Communicate departmental goals to ensure the production of cost-effective, quality-compliant products safely and efficiently.
Requirements
- At least 5 years of experience in batch processing, automation, commissioning, and validation in FDA/HPRA-regulated industries.
- Bachelor's degree in chemistry, pharmacy, engineering, or a related field (advanced degree preferred).
- In-depth knowledge of cGMP and pharmaceutical regulatory requirements.
- Strong understanding of contamination control and aseptic processing standards.
- Technical expertise in pharmaceuticals, biologics, or similar fields.
- Preferably, at least 1 year of supervisory experience in a team setting.
