Job Description
We are seeking a Senior Tech Transfer Specialist to join our team.
Key Responsibilities
* Collaborate with stakeholders on late-stage clinical and PPQ transfer requirements.
* Lead tier meetings to coordinate activities between local and international groups.
* Support development of process descriptions, models, and facility fits for continuous and fed-batch processes.
* Deliver GMP documents related to TT, such as risk assessments and change controls.
* Improve local TT procedures while maintaining compliance.
* Assist in developing future business solutions to reduce effort and risk.
* Ensure quality, compliance, and safety standards.
Required Skills and Qualifications
* Minimum 5 years pharmaceutical or biotech industry experience
* Bachelor's degree in Biotechnology, Engineering, Chemistry, or related field
* Project management and team collaboration experience
* Upstream and downstream Unit Operations knowledge for mAb manufacturing
* Quality management and compliance systems experience
Why Choose Us
This is an excellent opportunity to develop your skills and experience in tech transfer and work with a dynamic team. We offer a supportive and collaborative environment that fosters growth and success.