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Global Program Management - Manufacturing

Global Program Management - Manufacturing

ConfidentialBengaluru / Bangalore, India
5 days ago
Job description

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

Job Responsibilities

Operations Management of Manufacturing activities

  • Responsible for tracking and reporting manufacturing KPIs – Monthly, Quarterly & Annual reporting
  • Weekly MIS preparation & monthly report update
  • High level understanding of Supply Network Management.
  • Responsible for oversight on key issues
  • Responsible for tracking expenses monthly & Quarterly

Follow the Governance Structure and Escalation Matrix as defined within Global Program Management function

Scope and Schedule management : Follow the annual plan & budget

  • Track the Plan Vs Actual and report the variance.
  • Pro-actively track and report delays & issues
  • Monitor the progress through-out the schedule (MSP, Office timeline)
  • Stakeholder management : Effectively co-ordinate with cross functional teams within the organization and also with the partner teams for program deliverables. Manage communications, escalation & problem solving to ensure project deliverables stay on track

    Budget : Plan the cost centre budget (Annual / Quarterly / Monthly).

  • Budget forecasting for the Fiscal year
  • Finalize, Track and Report the Plan vs Actuals
  • Negotiation with the service providers for the program related activities.
  • Monitor / control project progression to ensure project is completed on schedule and within budget. Anticipate and provide visibility to internal / external stakeholders for scope / cost creep & revision
  • Regulatory :

  • Participate in contributing to regulatory strategy.
  • Liaise with RA team and finalize the regulatory pathway for variation filings
  • Legal :

    Liaise with the Legal team and ensure readiness of CDA, MSA, SOW etc. prior to the project execution.

    Logistics : Liaise with Procurement and Logistics teams to facilitate and track the shipments (project related materials, test items / drugs, testing / biological samples)

    Procurement : Liaise with procurement team for the availability of project related consumables, equipment & other critical reagents required for the program

    Note : This role is not for the candidate with experience in IT.

    Skills Required

    regulatory strategy, Stakeholder Management

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