-
Job Description
A highly motivated Technical Transfer Engineer is needed to manage technology transfers and support commercial production of large-molecule drug substances.
In this role, you will collaborate with manufacturing sites to ensure seamless process support, troubleshooting, and improvement initiatives.
Key Responsibilities:
- Lead technical activities for the manufacturing process at External Partners, including change control, process improvements, and investigations.
- Manage technical transfer activities by authoring/reviewing GMP documentation and ensuring regulatory compliance.
- Provide on-site support for commercial production and technology transfers.
- Develop standardized work processes, ensuring GMP requirements are met in collaboration with Operations, Quality, and External Partners.
- Participate in best practice sharing and support External Partners to ensure inspection readiness.
Qualifications:
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or related field.
- 4-5 years of Drug Substance Technical Transfer experience.
- Minimum of 4 years in a GMP functional area such as Operations, Technical Operations, or Engineering.
- Strong communication and teamwork skills.
- Willingness to travel (approximately 25% of time).
Preferred Skills:
- Experience in biologics upstream/downstream operations, process development, and tech transfer.
- Project management skills and experience with deviation management/change control.
- Proficiency in statistical analysis for process improvement.