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    Manager - Gscm (Project Management)

    Lupin
    8-10 years
    Not Disclosed
    Mumbai
    10 Nov. 28, 2024
    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: Manager - GSCM (Project Management)
    Date: November 19, 2024
    Location: Airoli, India
    Company: Lupin

    Job Description:

    The Manager - GSCM (Project Management) will be responsible for coordinating and managing the project activities related to the formulation development of regulated market and domestic market products at contract manufacturing organizations (CMOs). This role involves overseeing and tracking multiple projects, managing key stakeholders, ensuring the timely delivery of goods, and supporting the tech transfer processes.

    Key Responsibilities:

    1. CMO Sourcing & Coordination:

      • Source and manage suitable CMOs for export (regulated markets, RoW & US market).
      • Coordinate as a project management function to track the progress of formulation development projects at CMO sites, ensuring alignment with regulatory requirements and timelines.

    2. Project Tracking & Coordination:

      • Track and follow up on product development projects for regulated and domestic markets.
      • Collaborate with cross-functional teams (CFT) including Formulation Development, Analytical Development, CQA, DQA, RA, Legal, and Procurement to ensure smooth project progression.

    3. Document Evaluation & Coordination:

      • Evaluate document requirements and collaborate with internal teams (CQA, DQA, Research) to provide necessary documentation to CMO sites.
      • Arrange analytical requirements and assist CMO sites to initiate Analytical Method Transfer (AMT).

    4. Protocol Finalization & Document Handling:

      • Work closely with CMOs and internal CFTs to finalize documents, protocols, and related deliverables.

    5. Tech Transfer Coordination:

      • Manage and coordinate the entire technical transfer process from various stakeholders, ensuring smooth implementation.
      • Track progress activity-wise and ensure timely delivery of tech transfer milestones.

    6. Commercial Project Evaluation:

      • Review and analyze commercial project proposals received from CMOs.
      • Collaborate with the commercial team to evaluate export product forecasts and finalize costs.

    7. Purchase Order & Material Tracking:

      • Coordinate with the commercial team to arrange purchase orders (PO) to CMOs and track material requirements, shortages, and deliveries.
      • Ensure timely delivery of finished goods (FG) to meet On-Time In-Full (OTIF) goals.

    8. Agreement Management:

      • Track, initiate, and manage new CDA, Project, and Techno-commercial agreements.
      • Ensure the timely renewal of agreements in collaboration with the Legal department.

    Relevant Work Experience:

    • Experience:
      • 8 to 10 years of experience in project management, specifically in the pharmaceutical/contract manufacturing environment.

    Educational Qualifications:

    • Required:
      • B Pharma / M Pharma with MBA.

    Skills & Competencies:

    • Strong project management skills, with experience in tracking and coordinating cross-functional teams.
    • In-depth knowledge of regulatory requirements and formulation development processes.
    • Ability to evaluate and manage commercial proposals and forecasts.
    • Effective communication and collaboration with various stakeholders, including CMO, internal teams, and legal departments.
    • Familiarity with technical transfer processes and agreement management.

    Equal Opportunity Employer:
    We are committed to fostering an inclusive workplace and encourage all qualified individuals to apply.

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