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Joint Process Team Leader - Drug Product External Manufacturing

0-2 years
Not Disclosed
10 June 3, 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

 

Job Title:

Joint Process Team (JPT) Leader – Drug Product External Manufacturing


Location:

Gurgaon, Haryana, India
Job ID: R-86955
Category: Manufacturing/Quality
Job Type: Full Time | Fixed Term


Purpose:

The JPT Leader serves as the primary business owner of Lilly’s operational relationship with one or more Contract Manufacturers (CMs), providing cross-functional leadership to ensure quality, compliance, and supply continuity. The role includes strategic and operational oversight through Joint Process Teams and close collaboration with both internal and external stakeholders.


Key Responsibilities:

Strategic Leadership & Governance

  • Lead cross-functional Joint Process Teams (JPTs) between Lilly and Contract Manufacturers.

  • Develop and drive execution of Quality Plans, Supply Plans, and a shared Technical Agenda.

  • Ensure governance, monitor quality, safety, supply metrics, and initiate CAPAs or escalations as needed.

  • Ensure science-based, balanced team decision-making and continuous performance improvement.

Operational Execution

  • Act as the first point of escalation for issues from CMs.

  • Manage product schedules (production, batch release, shipment).

  • Ensure adherence to Lilly’s Manufacturing Requirements Document (MRD) and CM contracts.

  • Provide support for APRs, SCRs, OPVs, quality agreements, and validation reports.

CM Relationship Management

  • Make frequent (weekly) site visits to CM locations in India to maintain strong operational relationships.

  • Oversee conflict resolution, facilitate joint Steering Team meetings, and ensure action follow-up.

  • Support internal/external audits and inspections at CM sites.

Cross-functional Coordination

  • Collaborate with:

    • Quality, TS/MS, Supply Chain, and Procurement

    • Lilly affiliate leadership and Area management

    • Global Drug Product External Manufacturing (DPEM) team

    • Other Lilly manufacturing sites for knowledge exchange


Additional Responsibilities:

  • Own and lead internal Operational Process Reviews (iOPS).

  • Conduct or oversee FMEA and Root Cause Analysis with CM partners.

  • Support affiliate product portfolio management as needed.

  • Serve as a role model, living Team Lilly values and behaviors.


Requirements:

Education:

  • Bachelor’s degree or higher in a relevant technical or scientific field.

Experience & Skills:

  • Experience managing external manufacturing partnerships.

  • Strong cross-functional leadership, stakeholder management, and problem-solving skills.

  • In-depth knowledge of pharmaceutical manufacturing processes and compliance standards.

  • Excellent verbal/written communication and ability to travel frequently.