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Lilly TS/MS Representative - Drug Product External Manufacturing in Sesto Fiorentino, Italy

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.

Organization 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, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Drug Product External Manufacturing (DPEM) is responsible for making medicine at contract manufacturers located globally, selected by Lilly to make drug product that will bear the Lilly brand. DPEM manages technical, quality, supply and financial aspects of all issues with the contract manufacturers and alliances who supply product to Lilly to ensure risks to Lilly in manufacturing product outside Lilly is appropriate and provides optimum protection to the Lilly brand.

This role is responsible for all technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. This role is the process expert for the step(s) of the product(s) and process(es) for each contract manufacturing relationship. This role is a member of the joint process team and has direct responsibility for oversight of the day to day operations at the CM.

Key Objectives/Deliverables:

Support On-Going CM Operations by providing technical oversight

Understand the purpose and science of the process and have a thorough understanding of the entire process flow

Define, understand, and own the operational control strategy; including the key process parameters and critical quality attributes

Understand product history and potential failures modes for the process and the associate countermeasures

Generate, review, revise, and maintain as needed all the manufacturing and validation documentation (e.g. master production records and packaging orders, validation plans/protocols/reports, qualification protocols/reports, Process Flow Documents). Ensure those documents meet Lilly Global Quality Standards expectations.

Maintain awareness of issues & progress their resolution ensuring that senior management are notified through approved escalation procedures

Ensure planned changes and deviations are managed through the corresponding Lilly computer system. Respond in a timely manner and accurately to requests for information.

Ensure timely completion of annual product reviews (APRs) and Ongoing Process Verification (OPV), with action plans defined and monitored to ensure processes are in control, capable and in continuous improvement.

As required, represent DPEM in appropriate GPLOT (Global Post Launch Optimization Teams).

Ensure that Quality metrics are on target for the product/process supported: Deviation, Complaints, Quality Plan actions, Quality Backlog etc.

Relationship with CMO

Make regular communication with and visits to External Manufacturers to ensure current awareness of their operations and to maintain a strong working relationship with External Manufacturers, and the local affiliate if necessary.

Ensure Technical Agenda and discussion is agreed and executed in timely manner. Maintain technical visit and meeting minutes as required.

Identify training needs with the External Manufacturer. Arrange and conduct training during site visits if necessary.

Assist local affiliate with management of their product portfolio as required.

Support external and internal audits performed at the CM related to Lilly product portfolio.

Product Stewardship

Monitor critical process parameters, react to special/common cause and proactively generate improvement opportunities.

Ensure process control and capability. Establish metrics and incorporate them to daily process activity.

Understanding process and product regulatory commitments

As required be a source of technical information for other scientists and GLPOT. Active participation in Lilly Global Product Assessment, Site Compliance Report as any other request.

Resolve technical / quality issues, in conjunction with QA as required.

Lead Root Cause Analysis investigation and provide process expert knowledge in all deviations and complaints

Provide technical support on regulatory documents

Continuous Improvement

Analyze the process routinely in order to identify vulnerabilities and inefficiencies of the process and promote improvement projects

Monitor the status of processes to ensure they are consistent with, corporate standard expectations and the continuous improvement strategy.

Technical Transfer Projects

Liaise with engineering consultants, equipment suppliers, and others to define facility and equipment needs.

Provide help and guidance on development of appropriate manufacturing and quality systems, in conjunction with QA.

Develop and own the Technology Transfer Plan. Define (with the project lead and/or global molecule steward) the appropriate validation strategy according to the Regulatory and Lilly Standard expectation.

Review External Manufacturer qualification protocols and reports.

Supervise PQ, validation and manufacturing start up to ensure success.

Run Process Validation batches and document the results in the Final Validation Report.

Ensure External Manufacturer is technically competent to run the process and are made aware of any changes in technical requirements.

Inform properly and in a timely manner to TS/MS Sr. Director about project status, issues, etc. Identifying issues root case and recommended action plans to solve them and avoid recurrences.

Identifying resources and trainings needed to achieve area targets

Collaborate with Technical Project Manager to ensure the appropriate technical governance through the business processes.

Department Initiatives

Maintain regular communication with management and network leaders through effective participation in S&OP meetings, GPLOT and MR reviews

As a team member, actively participate and contribute to the Joint Process Team objectives.

Ensure appropriate actions are entered into and tracked through all monitoring systems.

Provide input in monthly reports and metrics

Actively pursue opportunities for continuous improvement (both process and procedural)

Model Safety behaviors

Effectively instruct/mentor others

Basic Requirements:

Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields

Minimum of 5 years experience in pharmaceutical manufacturing and/or technical services

Additional Preferences:

A thorough understanding of cGMPs and drug product manufacturing

Good communication skills, especially attention to detail in written procedures and protocol development

High degree of technical curiosity and critical thinking

High learning agility

Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment

Use of data and science to support decisions

Willingness to learn new technologies

Capability to work in a virtual and complex environment

Willingness to travel

Appreciation for cultural diversity

Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner and to influence CMs

Knowledge and ability to apply basic statistical tools

Regulatory related experience

Equipment, utility, and facility qualification experience

Established technical, quality, and internal networks

Prior experience supporting parenteral manufacturing

Additional Information:

Shift is days, but off-hours may be necessary to support operations

Travel is possible, up to 30%

This job is fast paced with changing priorities

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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