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Manufacturing Operations Associate

3+ years
Not Disclosed
10 March 25, 2025
Job Description
Job Type: Full Time Education: B.Tech/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

Manufacturing Operations Associate - Lebanon API Manufacturing
Location: Lebanon, Indiana, United States of America
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job Id: R-63866

Company Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, with a mission to make life better for people worldwide. Through innovation and discovery, Lilly provides life-changing medicines, improves disease management, and gives back to communities through philanthropy and volunteerism.

Position Overview:
Lilly is constructing an advanced manufacturing facility in Lebanon, IN, to produce API molecules, representing the company’s largest manufacturing investment to date. The Manufacturing Operations Associate (OA) role is critical to the startup and successful operation of this state-of-the-art facility.

Key Responsibilities:

  • Assist Process Team Leaders in leading Process Teams with a focus on safety, quality, and manufacturing performance using appropriate metrics and targets.

  • Ensure cGMP readiness of manufacturing areas for startup and process qualification activities.

  • Support validation activities and maintain compliance in GMP production areas.

  • Promote a safety-first culture emphasizing accountability, safe systems, and management commitment.

  • Act as a delegate for the Associate Director-Manufacturing to provide continuity in Process Team activities and escalate issues to the Senior Director of Manufacturing Operations.

  • Lead or participate in continuous improvement projects for capacity optimization and cost reduction.

  • Develop and drive the Operational Excellence Roadmap for LP1 Flow Team.

  • Manage manufacturing projects in collaboration with cross-functional stakeholders.

  • Author and revise SOPs and batch records, review technical reports, and conduct deviation investigations.

  • Document and communicate work outcomes and lessons learned.

  • Provide training and mentorship for new personnel.

Minimum Requirements:

  • Bachelor’s degree in Engineering, Chemistry, Biology, or a related technical field.

  • 3+ years of experience in Engineering, Chemistry, Biology, or Technical Services in a GMP environment (preferably pharmaceutical industry).

Additional Preferences:

  • Demonstrated operational capability with high productivity.

  • Strong problem-solving skills and a data-driven approach.

  • Excellent verbal and written communication skills.

  • Strong technical writing skills with attention to detail.

  • Knowledge of key technical services deliverables, including Tech Transfer, Process Monitoring, Process Validation, and Ongoing Process Verification.

  • Understanding of normal and special cause process variability.

  • Leadership potential with an interest in cross-functional operations leadership.

  • Flexibility to support off-shifts and attend meetings as needed.

  • Some domestic and international travel required (<10%).

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

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