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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:

The Ticket role is responsible for providing 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. This role will initially focus on the design and delivery of the MasterControl production instructions (referred to as tickets), and then transition to support of routine manufacturing operations, including identifying and implementing required MasterControl upgrades and ticket changes. While this role is not expected to be the technical expert on all products and platforms, it is expected to be the knowledgeable in regulatory, internal, and other requirements. A key part of this role is ensuring that there is consistency in approach / processes throughout the product lifecycle, from tech transfer to regulatory submission and beyond to routine manufacturing.

Key Objectives/Deliverables:

+ Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.

+ Partner with Tech@Lilly, Quality, Production, and Engineering (site based and globally) to develop reliable, sustainable, and compliant manufacturing MasterControl tickets.

+ Serve as MasterControl TS/MS subject matter expert (SME) and provide technical leadership to the MasterControl team, specific to process and ticket requirements for drug product manufacturing.

+ Translate product control strategy and process flow document (PFD) requirements into accurate instruction sets (e.g. MasterControl tickets, electronic batch records, electronic procedures).

+ Partner with Tech@Lilly MasterControl and other TS/MS scientist resources for ticket design and development inputs, including how MasterControl interfaces with other automation systems, LIMS systems, etc.

+ Lead/support development of new MasterControl tickets; maintain accuracy of MasterControl tickets and ensure that they can be executed as written.

+ Participate in design reviews, final design specification review, and localization of MasterControl tickets.

+ Provide technical support for all start-up activities (e.g., tech transfer, process validation).

+ Identify changes required for MasterControl, solicit input from stakeholders, and ensure changes are implemented consistently with operational practices.

+ Lead the change prioritization process, working with the business to understand change requirements and collaborating with Tech@Lilly to understand complexity.

+ Power user for MasterControl upgrades in order to write/approve test scripts accordingly.

+ 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 preparation of relevant technical documents specific to MasterControl, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.

+ Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.

+ Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements 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 in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.

+ Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Basic Qualifications:

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

+ Knowledge and understanding of parenteral drug product manufacturing, including equipment, facilities, computer systems and operations

+ Experience supporting cGMP manufacturing (specifically within 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 that demonstrate an ability to effectively (clearly, succinctly) 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, etc)

+ Proven understanding of manufacturing execution systems (MasterControl)

+ Technical knowledge of how to build and test in MasterControl

+ Ability to analyze complex data and solve problems

+ Demonstrated successful leadership of cross-functional teams

+ Project management experience

+ (Senior) 2+ years experience supporting cGMP manufacturing (within validation, engineering, TS/MS, operations, quality assurance, etc.)

+ (Principal) 5+ years experience supporting cGMP manufacturing (within validation, engineering, TS/MS, operations, quality assurance, etc.)

Additional Information:

+ Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /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. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$64,500 - $167,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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