Technology Transfer Scientist II
Job Description
Job Summary:
- 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.
Duties & Responsibilities/ % of Time Tasks:
- Author Tech 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.30%
- Author /update Manufacturing Transfer Plans and Reports related to the alternate site(s).25%
- Serve as liason between the current and new manufacturing locations as required.10%
- Ensure that all documentation and any updated versions are provided to the alternate manufacturing locations. 5%
- Perform other work-related duties as assigned. 100% Total
Minimum Education or Equivalent:
- Experience Required/Preferred Degree in Chemistry, Biochemistry, Biology or similar discipline preferred or minimum of 5 years experience in an Tech Transfer, Operations or Product Development/Support role within a GMP manufacutring facility.
- Minimum Years of Related Knowledge.
Skills and Abilities Required/Preferred:
- Minimum of 5 years experience in an Operational or Technical environment Demonstrated ability to successfully deliver aProductst project timelines Track record of contributing to cross-functional teams within a regulated environment.
- Required travel % (identify if domestic and/or international) Predominately site based, less than 5% domestic or international travel per year.