TSMS Scientist

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.

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 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.

Position Description

• 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.
• This role is based on Lilly Sesto site, near Florence (Italy).

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 3 years experience in pharmaceutical manufacturing and/or technical services
• Willingness to travel (up to 30% of your time, mainly EU travels)
• Very good level in English mandatory (read/spoken/written)

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
• Syringes aseptic filling experience
• Established technical, quality, and internal networks
• Prior experience supporting parenteral manufacturing, with a preference in syringes aseptic filling

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