Commercialization Technical Lead - Sesto Fiorentino, Italia - Eli Lilly

Descrizione

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 35,000 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.

Position description- The TSMS Technical Lead of Drug Products External Manufacturing (DPEM) Commercialization is responsible for providing technical leadership 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 all commercialization assets, including DPs and devices- This role serves as a role model and mentor within DPEM commercialization teams.

- A key part of this role is ensuring that there is consistency in approach and processes, up through and including submission- The TSMS Technical Lead can be involved on clinical trials and supports all the commercialization activities up to first submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Global Quality Standards (GQS) and Lilly Quality Standards (LQS)- The TSMS Technical Lead is also responsible for providing technical oversight and mentoring of DPEM primary and secondary loop TSMS resources to ensure the appropriate handover to commercial manufacturing

Main responsibilities

• Drug Product Commercialization Technical Leadership_

The DPEM Technical Lead provides technical guidance to Tech Transfer teams (including CM team members) to ensure that:

• appropriate Critical Quality Attributes are identified
• the process design is established based on knowledge gained from development studies and experience in similar manufacturing platforms
• input of process variability (including materials and components) is well characterized and communicated to commercial manufacturing operations
• potential issues are identified, documented, assessed, reduced/controlled/resolved or accepted
• product knowledge, process understanding, and a robust control strategy are developed, documented, and ultimately delivered to commercial manufacturing operations
• relevant internal and regulatory requirements are met, and appropriate data are generated and documented to support regulatory submissions

The DPEM Technical Lead collaborates with the Project Managers as well as cross-functional tech transfer team members and Chemistry, Manufacturing and Controls (CMC) development team to commercialize new products into CMs as follows:

• support DPEM Commercialization Project Managers to create commercialization timelines that include key milestones related with technical transfer and commercialization deliverables
• serve as technical interface with CMC development team, Lilly Molecule Stewards and DPEM Join Process Teams
• understand the scientific principles required for manufacturing DPs, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
• ensure the technical transfer of robust processes and establish appropriate critical and operational process parameters, in-process controls and specifications
• ensure that an accurate PFD describes the manufacturing process, including product and operational control strategies
• provide technical support to develop process monitoring to assess process variability and capability
• provide direction on tech transfer activities of drug product such as PV strategy, Stability strategy, Regulatory strategy, Submission Authoring, Regulatory Responses up through approval
• provide technical support to prepare, review and approve all relevant technical documents, such as change controls, Tech Transfer Plans, PFMEA, risk assessments, as required
• provide technical 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
• provide technical support for technical investigations and CAPAs, as needed
• provide data to support regulatory submission requirements
• if required, provide technical support to review submission Regulatory documentation

The DPEM Technical Lead supports (DPEM and DMS) gate reviews, Manufacturability Reviews (MRs), and other technical meetings as required

• DPEM Drug Product Commercialization Stewardship_
• Identify opportunities for best practices and improvements of commercialization and tech transfer processes
• Drive technical consistency in tech transfer deliverables: provide technical input/support across multiple product types, platforms and CMs, to ensure