Cypress HCM · 1 day ago
Technology Transfer Scientist
Cypress HCM is a global company in the medical devices industry, seeking a Technology Transfer Scientist to oversee process transfers and launch implementation activities for Transfusion Medicine Products. The role involves ensuring project milestones are met to maintain continuity of supply to customers.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
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
Qualification
Required
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
Predominately site based, less than 5% domestic or international travel per year
Can be flexible with start times, however will have 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