Scientist - TS/MS Batch Tickets

Eli Lilly and Company; Pleasant Prairie (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

A global healthcare leader is seeking a Scientist for the TS/MS Batch Tickets role. This position involves providing technical support for the execution of a manufacturing execution system, ensuring compliance and sustainability in drug product manufacturing. Candidates should have a BS or MS in a relevant discipline and experience in cGMP manufacturing. The role requires strong communication and problem-solving skills, with flexibility in working hours.

Qualifications

• Experience supporting cGMP manufacturing in various roles.
• Oral and written communication skills to interact at all organizational levels.
• Ability to learn new processes and applications quickly.

Responsibilities

• Understand scientific principles for manufacturing drug products.
• Partner with various departments to design and develop MasterControl tickets.
• Lead training and troubleshooting for Operations.

Skills

Knowledge of parenteral drug product manufacturing

Strong computer skills

Strong interpersonal and teamwork skills

Ability to analyze complex data and solve problems

Education

BS or MS in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related scientific discipline

Tools

MasterControl

Computer systems for manufacturing

Job description

Overview

Join to apply for the Scientist - TS/MS Batch Tickets role at Eli Lilly and Company.

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 put people first and strive to help life be better for people around the world.

The Ticket role provides technical support for the development, implementation, and execution of a manufacturing execution system (electronic batch record) to achieve reliable, sustainable, and compliant manufacturing of drug products at the Lilly Kenosha County (LKC) site. The initial focus is on the design and delivery of MasterControl production instructions (tickets), followed by support of routine manufacturing operations and MasterControl upgrades and ticket changes. The role is not expected to be the technical expert on all products and platforms, but should be knowledgeable about regulatory, internal, and other requirements. A key part is ensuring consistency in approach and processes throughout the product lifecycle, from tech transfer to regulatory submission and beyond to routine manufacturing.

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Partner with Tech@Lilly, Quality, Production, and Engineering (site-based and global) to develop reliable, sustainable, and compliant MasterControl tickets.
• Serve as MasterControl TS/MS SME and provide technical leadership to the MasterControl team for process and ticket requirements in drug product manufacturing.
• Translate product control strategy and process flow document requirements into accurate instruction sets (e.g., MasterControl tickets, electronic batch records, electronic procedures).
• Collaborate with Tech@Lilly MasterControl and other TS/MS resources for ticket design and development inputs, including MasterControl interfaces with other automation systems and LIMS.
• Lead or support development of new MasterControl tickets; maintain accuracy of tickets and ensure they can be executed as written.
• Participate in design reviews, final design specification reviews, and localization of MasterControl tickets.
• Provide technical support for start-up activities (e.g., tech transfer, process validation).
• Identify changes required for MasterControl, gather stakeholder input, and ensure changes align with operational practices.
• Lead the change prioritization process, coordinating with the business and Tech@Lilly to understand complexity.
• Act as power user for MasterControl upgrades to write/approve test scripts.
• Lead training and troubleshooting for Operations.
• Provide technical support for non-routine investigations (e.g., deviations, complaints).
• Prepare, review, approve, and provide technical support for relevant MasterControl documents (change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.).
• Develop and monitor statistically based metrics to assess process variability and capability; apply data analysis to support daily manufacturing operations.
• Support and/or lead TS/MS technical projects to ensure successful start-up, improve process control, yield, product quality, and productivity; implement process changes through the technical agenda.
• Serve as technical interface external to the LKC site.
• Provide audit support as needed.
• Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business and quality goals.
• Maintain a safe working environment by complying with safety rules and participating in safety activities.

Basic Qualifications

• BS or MS in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, Biochemical Engineering, or related scientific discipline
• Knowledge of parenteral drug product manufacturing, including equipment, facilities, computer systems and operations
• Experience supporting cGMP manufacturing (Operations, Validation, Engineering, TS/MS, Quality Assurance, etc.)
• Ability to learn new processes and computer system applications
• Strong computer skills
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills to effectively communicate with all levels of the organization

Additional Skills/Preferences

• Experience in TS/MS, MSAT, Operations, or Quality Assurance
• Understanding of operational control strategy (e.g., CQA, CPP, CIPC)
• Proven understanding of manufacturing execution systems (MasterControl)
• Technical knowledge of building and testing in MasterControl
• Ability to analyze complex data and solve problems
• Demonstrated leadership of cross-functional teams
• Project management experience
• (Senior) 2+ years experience supporting cGMP manufacturing (validation, engineering, TS/MS, operations, quality assurance)
• (Principal) 5+ years experience supporting cGMP manufacturing (validation, engineering, TS/MS, operations, quality assurance)

Additional Information

• Role is Monday through Friday. Must be flexible to provide support for production schedules, shutdowns, etc. Occasional extended hours or off-hour work may be required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. Job requirements may change over time. As always, consult with your supervisor regarding actual responsibilities.

Lilly is dedicated to helping individuals with disabilities to participate in the workforce and provides equal opportunities in hiring. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, or disability.