Technology Transfer Scientist 2

Position 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.

Major Duties & Responsibilities:

• 30% Author Tech Transfer deliverable checklists to ensure that all prequisite 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 liason 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.
• Perform other work-related duties as assigned.

Qualifications:

Minimum Education or Equivalent:

• 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 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.