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Operations Line Lead – Formulation/Preparation

2-5 years
Not Disclosed
10 March 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Operations Line Lead – Formulation/Preparation

Location: Pleasant Prairie, Wisconsin, United States
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job ID: R-72223

Company Overview:
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, with employees worldwide working to discover and deliver life-changing medicines. We are committed to improving disease management, giving back to our communities through philanthropy, and putting people first.

Organization Overview:
For over 140 years, Lilly has focused on discovering medicines that make life better. Our scientists work at Lilly Research Laboratories to create new medicines that address the world’s greatest health challenges, using next-generation therapeutics, advanced technologies, and data analytics to improve patient health and the healthcare system.

Responsibilities:

  • Support commissioning/qualification activities and operational readiness during the project phase.

  • Develop area operational procedures, quality processes, and controls for the Formulation area.

  • Provide frontline leadership on the manufacturing floor, ensuring safety, quality, and productivity.

  • Serve as the primary point of contact for troubleshooting and unexpected floor events.

  • Coordinate and deploy technical training while ensuring operators are qualified to perform tasks.

  • Assist in performance evaluations and development of shift operators.

  • Act as a key liaison between operations and support functions.

  • Operate equipment and lead shift operations to meet production demands.

  • Review execution documentation (Mastercontrol, SAP, Cleaning Logs, etc.).

  • Drive key objectives including safety improvement, deviation reduction, and training compliance.

  • Serve as backup for the Supervisor.

Key Objectives:

  • Ensure high safety, quality, and productivity standards.

  • Train and mentor peers effectively.

  • Troubleshoot issues and ensure operational compliance.

  • Drive continuous improvement initiatives.

Basic Requirements:

  • High School Diploma or equivalent.

  • 2-5 years of relevant experience in pharmaceutical or medical device manufacturing (education may substitute for experience at manager's discretion).

  • Demonstrated leadership skills and ability to train peers.

  • Strong communication (written and verbal) and problem-solving skills.

  • Basic digital literacy and ability to lift 45 lbs.

  • Ability to work 12-hour shifts (2-2-3 schedule) with additional overtime as needed.

  • Knowledge of current Good Manufacturing Practices (cGMPs).

  • Previous experience in compounding/formulation in a Grade C environment.

  • Legal authorization to work in the United States without sponsorship.

Additional Skills/Preferences:

  • Experience with pH meters, water baths, API dispensing, autoclaves, and filter integrity testing.

  • Scientific/technical degrees or certifications.

  • Familiarity with Manufacturing Execution Systems and electronic batch release.

  • Knowledge of lean manufacturing principles.

  • Ability to wear safety equipment (glasses, shoes, gloves, PAPR).

Additional Information:

  • Position is located at the Lilly Kenosha County site.

  • Flexible working schedule during project phase, including days or nights.

  • Ability to gown and work in controlled classified areas.

Equal Employment Opportunity:
Lilly is an EEO/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

Accommodations:
If you require an accommodation to apply, please contact Lilly Human Resources at
Lilly_Recruiting_Compliance@lists.lilly.com or submit an accommodation request through Lilly Careers Accommodation Request.

#WeAreLilly

 

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