Biologics Manufacturing and Process Optimization Leader
6 days ago
We are seeking a highly skilled and experienced Technical Transfer Engineer to join our team. As a key member of our External Manufacturing (ExM) Technical Operation organization, you will be responsible for leading technical activities related to commercial manufacturing processes at our External Partners.
Main Job Duties:- Work closely with External Partners to achieve business objectives and establish a shared culture that benefits our company, partners, and patients.
- Develop and manage technical activities, including change control documents, process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Oversee technical transfer activities, including authorship and/or review of required GMP documentation and regulatory filings.
- Support Commercial and/or Technology Transfer Person-In-Plant Activities at External Partner sites.
- E nsure that External Partners are prepared for all routine inspections and/or inspections related to new product introductions or transfers.
- Partner with Operations, Quality, and Regulatory teams to develop standardized work to meet GMP requirements and current regulations.
- Contribute to the creation, sharing, and adoption of business process and best practices strategies.
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or other related science or engineering field.
- 4+ years of post-bachelor's degree experience in a GMP functional area or support of a GMP functional area.
- Excellent communication skills in English and teamwork skills.
- Approximately 25% travel requirement.
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