Technology Transfer Scientist

Technology Transfer Scientist

Location:

Raritan, NJ - onsite to start, potential for hybrid later on

This is an exciting opportunity to join a global company in the medical devices industry. The individual is responsible for the execution of process transfers and launch implementation activities associated with moving production of Transfusion Medicine Products from their current manufacturing location to alternate sites. The individual must ensure that key project milestones are met to ensure the overall project goals are met and continuity of supply to customers is maintained.

• 30% - Author Technology Transfer deliverable checklists to ensure that all prerequisite requirements are in place prior to manufacturing the verification (Transfer), Validation and launch lots of products. Ensure all objective evidence and supporting evidence is obtained and meets requirements.
• 30% - Ensure receiving site protocols and reports are aligned to the manufacturing transfer plans and that transfer and validation lots meet requirements.
• 25% - Author/Update Manufacturing Transfer Plans and Reports related to the alternate site(s)
• 10% - Serve as liaison between the current and new manufacturing locations as required.
• 5% - Ensure that all documentation and any updated versions are provided to the alternate manufacturing locations.
• Working relationships across Internal Operations, Quality, Supply Chain, Raw Material Supply, Engineering, R&D.

• Degree in Chemistry, Biochemistry, Biology or similar discipline preferred or minimum of 5 years’ experience in a Tech Transfer, Operations or Product Development/Support role within a GMP manufacturing facility.
• Minimum of 5 years’ experience in an Operational or Technical environment. Demonstrated ability to successfully deliver against project timelines. Track record of contributing to cross-functional teams within a regulated environment.
• Required travel:
  Predominantly site based, less than 5% domestic or international travel per year.
• Can be flexible with start times; however there will be some meetings with 3rd party suppliers located internationally across Europe and Australia, so may need some flexibility to take earlier morning EST calls or later afternoon calls for Australia.

Pay Rate: $35-$45/hour