DPEM Commercialization TSMS Rep

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities

The TSMS Representative of Drug Products External Manufacturing (DPEM) Commercialization is responsible for providing technical support to commercialization activities within DPEM. DPEM is responsible for the commercialization of drug products (DPs) at selected contract manufacturers (CMs) located globally.

The scope of the role includes technical support for all commercialization assets. A key part of this role is supporting each commercialization project to ensure consistency in approach and processes, up through and including submission.

The DPEM TSMS Commercialization Representative is also responsible for providing process oversight, according to the product control strategy and governing documentation, to ensure the appropriate handover to the commercial manufacturing unit.

Key Objectives/Deliverables:

• Understanding of the scientific principles required for manufacturing DPs, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Understanding of secondary packaging and device assembly processes.
• Preparation and contribution or review of commercialization deliverables (e.g. change controls, Tech Transfer Plans, PFMEA, risk assessments, etc., as required).
• Support in writing and implementing new SOPs according to the DPEM requirements and cGMPs.
• Guarantee the technical transfer process parameter such as critical and operational process parameters, in-process controls and specifications are followed.
• Serves as technical support interface between CM and DPEM.
• Provide support for the execution of activities and key commercialization deliverables (such as PV protocol, technical and engineering studies, demo batch protocols) to enable batch manufacture and tech transfer activities of drug products.
• If required, provide technical support for technical investigations and CAPAs, as needed.
• Support collecting the data to support regulatory submission requirements.
• Assist the process monitoring implementation to monitor process variability and capability.
• Be able to identify/document/assess potential issues.
• Ensure that all transfer docs are aligned and consistent agreeing with the PFD describing the manufacturing process, including product and operational control strategies.
• Transition with DPEM primary and secondary loop organizations according to the handover plan.

Relationships:

• Contract Manufacturing leadership and functions.
• All relevant functions at the Lilly Networks (such as M&Q central functions, Product Development and Regulatory Affairs).
• DPEM and Lilly External Manufacturing teams (API, IDM).

Basic Qualifications

• Bachelor’s Degree or higher in science or science related field such as Pharmacy, Chemistry, Engineering, Biological Science, or related Life Sciences.
• Experience with DP manufacturing technologies/processes.
• Experience with DP technical transfers and commercialization of new drug products.
• Experience with qualification of DP manufacturing equipment, utility, and facility.
• Self-management and organizational skills to produce quality deliverables within established time frames.
• Demonstrated ability of collaboration to operate cross functionally and hold technical/process discussions with third parties.
• A thorough understanding of cGMPs.