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.
This role is responsible for 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 with focus on Device Assembling and Packaging. This role is a member of the joint process team (JPT) and has direct responsibility for oversight of the day-to-day operations and technical agenda at the CM.
Main Responsibilities: Support On-Going CM Operations by providing technical oversight at the Joint Process Team as Primary Loop supportThe TS/MS Rep in the Joint Process team should be or become the process expert with regards to the process steps or processing equipment within the scope of the process team including:Understanding the purpose and the science of the process and have a thorough understanding of the entire processUnderstanding and owning the process control strategy including the key process parameters, critical quality attributes, and the historic and potential failure modes of the processKnowing the product process, development and validation historyTranslating process requirements and education to the Joint Process team membersDocumenting work and learnings in an official source such as Process Flow Diagrams.Understand the scientific principles required for Device Assembly and Packaging OperationsThe TS/MS Rep in the joint process team should ensure that the process is maintained in a validated / capable state that includes:Participating in the design and execution process, cleaning strategies and validation process (PV/PPQ) and oversight of any documentation associated as required.Having a holistic understanding of the process, and its associated equipment, facilities, computer system and operations and provide oversight to any PQ activity at the CMs.Ensure that there is an accurate process flow diagram that describes the process, control strategy, process parameters and critical quality attributesEnsure process remains in a validated state through routine monitoringEnsure 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.Assist Quality and Supply Chain personnel in the timely completion of SCR, Quality Agreement and MRDs, as necessaryAssist the CMs on the preparation of any audit from Lilly (GQAAC) or any external agency that impact Lilly products.The TS/MS Rep in the process team should provide support to management of daily operations by:Using statistical tools to understand and reduce sources of variability and continuously improve the process.Using data history and other sources to extract relevant process parameters.Leading process-related root cause analysis and providing expert process knowledge in all incident investigations.Owning process-related deviations, complaints, corrective and preventative actions, and changes.Assist the CMs on the batch records and revisions, and assure they remain accurate.Serving as a liaison to other scientific and/or technical experts outside the process team such as Secondary Loop SMEs and Molecule Stewards.The TS/MS Rep in the process team should own the process capability and yield variables and identify opportunities for improvement. This includes:When variation arises, the TS/MS Rep should be able to assist the process team in identifying if the variation source is from common or special cause.Analyze the process routinely in order to identify vulnerabilities and inefficiencies of the process and promote improvement projectsMonitor the status of processes to ensure they are consistent with corporate standard expectations and the continuous improvement strategy.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 a timely manner.Technical Transfer Projects: TS/MS Rep will participate in Technical Transfer Project as required.Collaborate with Technical Project Manager to ensure the appropriate technical governance through the business processes.Participate in PQ, validation and manufacturing readiness and start-up to ensure success.Department Initiatives: As a team member, actively participate and contribute to the Joint Process Team objectives.Provide input in monthly reports and metrics.Actively pursue opportunities for continuous improvement (both process and procedural).Model of Safety behaviors.Required Qualifications: Master's Degree in Pharmacy, Chemistry, Engineering, or similarly related fields.Ability to represent Eli Lilly's mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.Minimum of 2 years' experience in pharmaceutical manufacturing and/or technical services.Understanding of cGMPs and drug product manufacturing.Fluent in English (B2/C1 Level).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 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.Additional Preferences: Prior experience supporting Device assembly and/or packaging experience.Knowledge and ability to apply basic statistical tools.Regulatory related experience.Equipment, utility, and facility qualification experience.Established technical, quality, and internal networks.Other information: Travel is possible, up to 30%.
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