- Establish plans and deliver on the established Production Operation’s annual goals and objectives.
- Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation.
- Instill a culture of continuous process improvement with a quality focus. Pursue industry “best practices” associated with clinical and commercial production operations.
- Manage daily production operations in late phase clinical, new product launch and commercial manufacturing.
- Review Master Batch Records, SOPs, Qualification/Validation protocols and reports, and other essential cGMP documents.
- Write and revise Standard Operating Procedures and other operational documents as needed.
- Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion.
- Provide appropriate coaching, development, and associated performance management for the production operations staff.
- Bachelor’s Degree in Scientific, Engineering or related discipline
- 3 years of experience in medical device or pharmaceutical drug product manufacturing with specific responsibilities in supervision and new product introduction or equivalent experience
- In-depth knowledge of cGMPs and working in a regulated environment
- Experience writing and developing SOPs and other regulatory documentation
- Proficiency in Microsoft Office Applications
- Excellent organization, communication and analytical skills are required
- Ability to develop and maintain department and cross-functional relationships and build effective manufacturing team
- Experience working in cleanroom environment
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