Tech Transfer Specialist

Proclinical is seeking a dedicated Tech Transfer Specialist with a focus on ophthalmology. The successful candidate will be responsible for transferring manufacturing processes, compiling regulatory documentation, managing deviations and change control, and maintaining information on manufacturing equipment and CMO knowledge. This role is ideal for someone who is self-motivated, results-focused, and comfortable working in a matrix environment.

Responsibilities:

• Transfer of the manufacturing method/process to the CMO, including providing all necessary details and specifications.
• Compilation of transfer protocols and reports in cooperation with the CMO.
• Compilation of regulatory documentation on manufacturing process and primary packaging materials.
• Management of process and filter validations of the transferred manufacturing processes.
• Management of deviations and change control.
• Maintenance of information on manufacturing equipment and CMO expertise.
• Participation in the Global Tech Transfer Project (GTTP) process.
• Other duties as assigned.

Key Skills and Requirements:

• Degree in pharmacy, medical, or life sciences.
• Understanding of GMP requirements and knowledge in the manufacturing of sterile products.
• Ability to operate and communicate effectively both internally and externally.
• Experience in product support and/or technology transfers.
• Ability to work cross-functionally and cross-culturally.
• Self-motivated and results-focused.
• Excellent writing, editing, and computer skills, including proficiency in MS Office.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.salh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.