Manager 2 - Technology Transfer

Pay Rate : $37 - $41 / Hour

12 months contract

This role is for an SME in aseptic drug product manufacturing who will be responsible to lead the coordination of activities to transfer the drug product fill-finish process to the manufacturing site. The process consists of compounding, filling, and optical inspection. In this role the incumbent is charged with leading complex Technology Transfers and Process Performance Qualification (process validation) that drive reliability and sustainability of our products at external manufacturers.

This person will provide the technical insight and team leadership role to effectively deliver qualification of equipment, methods, hold times, and manufacturing processes aligned with the supply chain network strategy. This role will partner with External Manufacturers and client Innovative Medicine Quality, Planning, and Partnership & External Supply. The team will ensure processes are flawlessly introduced into the supply chain network and ongoing production consistently satisfies quality and regulatory needs.

The incumbent must be able to :

• Work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in-depth evaluation of factors in multifunctional areas
• Communicate efficiently with their core team
• Influence other functions / levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties.
• Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during production of qualification batches.

The incumbent should be an expert in biologic drug product manufacturing processes. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.

Process validation knowledge for pharmaceutical ingredients or products is desirable.

Domestic travel to manufacturing site required, up to 25%. (Travel to Greenville, NC about 1x a month with short notice).

Tasks and responsibilities

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