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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.

Responsibilities

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 (JPT) and has direct responsibility for oversight of the day to day operations and technical agenda at the CM.

Key Objectives / Deliverables :

Support On-Going CM Operations by providing technical oversight at the Joint process Team as Primary Loop support :

• The 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 :
• Having a holistic understanding / knowledge of the product / process, and its associated equipment, facilities, computer system and operations.
• Defining, understanding, and owning the process control strategy including the key process parameters, critical quality attributes.
• Understanding product history and potential failure modes of the process.
• Translating process requirement and education to the Joint Process team members.
• The TS / MS Rep in the joint process team should ensure that the process is maintained in a validated / controlled / capable state that includes :
• Participating in the design and execution process, cleaning, and sterility and Bioburden control (for parenteral product) strategies and post commercialization validation process (PV / PPQ) and oversight any documentation associated as required.
• Ensure that there is an accurate process flow diagram that describes the process, control strategy, process parameters and critical quality attributes.
• Ensure process remains in a validated state through routine monitoring.
• 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.
• Assist Quality and Supply Chain personnel in the timely completion of SCR, Quality Agreement and MRDs, as necessary.
• Assist to 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 :
• Owning process related deviations, complaints, corrective and preventative actions, and changes.
• Leading process related root cause analysis and provide expert process knowledge in all incident investigations (e.g. by using data history and other sources to extract relevant process parameters).
• Ensuring planned changes and deviations are managed appropriately. Respond in a timely manner and accurately to requests for information.
• Maintaining awareness of issues & progress their resolution ensuring that senior management are notified through approved escalation procedures.
• Assist the CMs on the batch records and revisions, and assuring 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 :
• Monitor the status of processes routinely, analyzing them by using statistical tools in order to :
• understand and reduce sources of variability.
• continuously improve the process.
• 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 timely manner.
• 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 (if required).
• Inform properly and in a timely manner to TS / MS Associate Director about project status, issues, etc. Identifying issues root case and recommended action plans to solve them and avoid recurrences.

Department Initiatives :

• Maintain regular communication with management and network leaders through effective participation in GPLOT, CPLOT etc.
• As a team member, actively participate and contribute to the Joint Process Team objectives.
• Provide input in monthly reports and metrics through the JPT.
• Actively pursue opportunities for continuous improvement (both process and procedural).
• Model of Safety behaviors.

Relationships :

• All functions at the contract manufacturers from senior management to shop floor personnel.
• Lilly Affiliate personnel and senior Country and Area management (if required).
• Lilly TS / MS, QA, Auditing groups, Laboratories at Lilly sites.
• Senior TS / MS management, Product and Technical leaders, GPLOT leaders and molecule and device stewards.

Basic Qualifications

• Bachelor's Degree in Pharmacy, Chemistry, Engineering, or similarly related fields.
• Minimum of 5 years' experience in pharmaceutical manufacturing and / or technical services.

Additional Skills / Preferences

• Ability to represent Eli Lilly's mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
• 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.
• 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 %.

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Last updated : 2024-05-14