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.
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.
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.
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
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.
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
Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields
Minimum of 3 years experience in pharmaceutical manufacturing and/or technical services
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
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
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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).