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Responsibilities
The Parenteral Process Engineer of Drug Products External Manufacturing (DPEM) is responsible for providing engineering technical support to commercialization activities within DPEM.
DPEM is responsible for the commercialization of drug products (DPs) at selected contract manufacturers (CMs) located globally, but also is responsible for technology transfers of Drug Products that have been already approved
The scope of the role includes all parenteral assets. The scope can include technical transfer of newly launched products, products in the process of launching, but also products already approved that can require additional capacity.
A key part of this role is ensuring that there is consistency in approach and processes, up through and including first submissions and approval.
DPEM Parenteral Process Engineer can be involved with clinical trials and supports all the commercialization activities up to first submissions and approval of the DP by providing technical support to ensure processes are in alignment with Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and DPEM commercialization procedures.
The DPEM Parenteral Process Principal Engineer is also responsible for providing technical oversight of DPEM team members and to ensure the appropriate handover to commercial manufacturing.
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Basic Qualifications
Additional Skills/ Preferences
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Other Information:
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