Duties will include:
1. Responsible for technical activities for the commercial manufacturing process at the CMO Partner, which includes authorship of change control, management of process improvement projects, and analysis of process performance.
2. Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
3. Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
4. Translate understanding of GMP requirements and current regulations and develop standardised work to meet these requirements by partnering with Operations, Quality, and External Partners.
5. Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
Requirements:
6. Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
7. Must Have Drug Substance Technical Transfer Experience for this role (4/5 Years).
8. Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
9. Travel will be a requirement of this position at approximately 25%
10. Strong communication and teamwork skills
11. Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
12. Demonstrated ability to independently manage projects/work to schedule/deadlines
13. Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
14. Experience in deviation management and/or change control and/or equipment support, and/or project management.
Apply now to discuss this role in further detail.
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