Commercialization Technical Lead

1 settimana fa

Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno
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/suppor

  • Associate - Quality Assurance Assembly&device

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    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...

  • Ict Sector Lead Auditor

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia DNV A tempo pieno

    Local Unit & Position Description:The Lead Auditor is a function in DNV Business Assurance Italy with the objective of leading the audit team in performing audits/assessment according to DNV standards and protocols, international standards or equivalent national standards and according to the established DNV methodologies/rules. Plan and execute audits,...

  • Sr. Principal Associate-GQAAC

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're looking for people who are determined to make life better for people around the world. The Quality Auditor is part of the Lilly Global Quality Auditing and Compliance (GQAAC) division and assures quality assurance through the execution of internal and external audits in support of pharmaceutical development, product commercialization, for Lilly....

  • Process Expert

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    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...

  • Engineer - Project Manager, Global Packaging and Serialization

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're looking for people who are determined to make life better for people around the world. Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications,...

  • Manutentore Elettromeccanico

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia ADECCO ITALIA A tempo pieno

    Adecco Italia S.p.a ricerca un/a addetto/a alla MANUTENZIONE ELETTROMECCANICA per diretto inserimento presso società multinazionale leader nel settore dell'energia e dei multiservizi che dovrà gestire il servizio di manutenzione per azienda in provincia di Firenze.La risorsa, inserita all'interno del team di manutenzione, riporterà al Technical Lead e, in...

  • Sr. Principal Associate

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    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...

  • Sales Area Manager Florence

    1 settimana fa

    Sesto Fiorentino, Toscana, Italia DNV A tempo pieno

    Local Unit & Position Description: DNV Business Assurance Italy is seeking a Sales Area Manager, who will be responsible for crosselling and new sales for the assigned territory and customers list within the Tuscany region.Key responisibilities: Ensure the achievement of sales target for the assigned Area and Customer segment. Maintain and develop high level...

  • Technical Lead

    4 settimane fa

    Sesto San Giovanni, Italia Dgs S.P.A. A tempo pieno

    Posizione Per il nostro Centro di Competenza Open Square siamo alla ricerca di un Technical Lead da inserire sul processo di sviluppo del nostro prodotto proprietario, Open Square, Una suite gestionale e collaborativa, modulare, integrabile e personalizzabile per le PMI.Il candidato dovrà:coordinare il team di lavoro per lo sviluppo del prodotto;essere il...

  • Technical Lead

    3 settimane fa

    Sesto San Giovanni, Italia Dgs S.P.A. A tempo pieno

    Posizione Per il nostro Centro di Competenza Open Square siamo alla ricerca di un Technical Lead da inserire sul processo di sviluppo del nostro prodotto proprietario, Open Square, Una suite gestionale e collaborativa, modulare, integrabile e personalizzabile per le PMI.Il candidato dovrà:coordinare il team di lavoro per lo sviluppo del prodotto;essere il...

  • Technical Lead

    1 mese fa

    Sesto San Giovanni, Italia DGS S.p.A. A tempo pieno

    Posizione Per il nostro Centro di Competenza Open Square siamo alla ricerca di un Technical Lead da inserire sul processo di sviluppo del nostro prodotto proprietario, Open Square, Una suite gestionale e collaborativa, modulare, integrabile e personalizzabile per le PMI. Il candidato dovrà: coordinare il team di lavoro per lo sviluppo del prodotto; ...

  • Technical Lead

    3 settimane fa

    Sesto San Giovanni, Italia DGS S.p.A. A tempo pieno

    Posizione Per il nostro Centro di Competenza Open Square siamo alla ricerca di un Technical Lead da inserire sul processo di sviluppo del nostro prodotto proprietario, Open Square, Una suite gestionale e collaborativa, modulare, integrabile e personalizzabile per le PMI. Il candidato dovrà: coordinare il team di lavoro per lo sviluppo del prodotto; ...

  • Associate - Quality Assurance Assembly&device

    2 mesi fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    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...

  • QA Representative DPEM

    3 settimane fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. MAIN RESPONSIBILITIES Te position is opened in Fegersheim, Sesto or Alcobendas. To act as the primary Lilly (DPEM) quality contact for the following: Provide quality support for existing products / existing External Manufacturers (EM) The roles and...

  • QA Representative DPEM

    4 settimane fa

    Sesto Fiorentino, Italia Eli Lilly and Company A tempo pieno

    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...

  • QA Representative DPEM

    1 mese fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. MAIN RESPONSIBILITIES Te position is opened in Fegersheim, Sesto or Alcobendas. To act as the primary Lilly (DPEM) quality contact for the following: Provide quality support for existing products / existing External Manufacturers (EM) The roles and...

  • QA Representative DPEM

    3 settimane fa

    Sesto Fiorentino, Italia Eli Lilly and Company A tempo pieno

    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...

  • Ict Sector Lead Auditor

    3 settimane fa

    Sesto Fiorentino, Italia DNV A tempo pieno

    Local Unit & Position Description: The Lead Auditor is a function in DNV Business Assurance Italy with the objective of leading the audit team in performing audits/assessment according to DNV standards and protocols, international standards or equivalent national standards and according to the established DNV methodologies/rules. - Plan and execute audits,...

  • Ict Sector Lead Auditor

    2 mesi fa

    Sesto Fiorentino, Italia DNV A tempo pieno

    Local Unit & Position Description: The Lead Auditor is a function in DNV Business Assurance Italy with the objective of leading the audit team in performing audits/assessment according to DNV standards and protocols, international standards or equivalent national standards and according to the established DNV methodologies/rules. - Plan and execute audits,...

  • Engineer - Serialization (Track & Trace) Lead

    2 settimane fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. What You’ll Be Doing The Engineer – Serialization Lead (GSP - Global Serialization Program) is accountable for the delivery of the serialization system in new secondary packaging lines at existing and new sites as an automation engineering representative...

  • Process Expert

    3 giorni fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    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...

  • Sr. Principal Associate-GQAAC

    3 settimane fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. The Quality Auditor is part of the Lilly Global Quality Auditing and Compliance (GQAAC) division and assures quality assurance through the execution of internal and external audits in support of pharmaceutical development, product commercialization, for Lilly....

  • Sr. Principal Associate-GQAAC

    1 mese fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. The Quality Auditor is part of the Lilly Global Quality Auditing and Compliance (GQAAC) division and assures quality assurance through the execution of internal and external audits in support of pharmaceutical development, product commercialization, for Lilly....

  • Sub Category Lead I

    3 settimane fa

    Sesto San Giovanni, Italia TechnipFMC A tempo pieno

    TechnipFMC is a global leader in the energy industry, specialized in subsea and surface technologies integrated projects, products, and services. Our mission and vision: to enhance the performance and drive real change in the traditional and new energy industry. How we do it: by constantly challenging conventions, tackling some of the most complex technical...

  • Associate Director

    2 settimane fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    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...

  • Sr. Principal Scientist

    1 mese fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. Responsibilities DPEM TS/MS Sterility Assurance/Micro Secondary Loop Subject Matter Expert provides oversight, assistance, and guidance to CMs and other DPEM members for parenteral quality assurance activities. Secondary loop is responsible for improving...

  • Sr. Principal Scientist

    3 settimane fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. Responsibilities DPEM TS/MS Sterility Assurance/Micro Secondary Loop Subject Matter Expert provides oversight, assistance, and guidance to CMs and other DPEM members for parenteral quality assurance activities. Secondary loop is responsible for improving...

  • Engineer - Project Manager, Global Packaging and Serialization

    1 mese fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough...