Technology Transfer Scientist

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: 

• 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 alteranate manufacturing locations.
• Perform other work-related duties as assigned.

Education & Experience:

• 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.

Knowledge, Skills and Abilities:

• Demonstrated ability to successfully deliver a product 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.