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Program Management - Malaysia

Salary undisclosed

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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.

Responsibilities:

  • Performance reporting : Ensure the performance KPI’s of the operations teams are tracked and reported out to the leadership team (Weekly and Monthly) for Drug Substance and Drug Product Operations
  • Prepare the Operation Performance Dashboards for the Leadership teams (Monthly and Quarterly)
  • Identify opportunities to improve operational performance with the functional team – Identify projects, Prepare the plan and ensure continous improvement for operations team (Throughput, Yield, Downtime)
  • Liaise with Development Program Manager to ensure Site readiness for Tech Transfer : Track the document readiness and batch execution of Development and Life cycle management programs [Insulin and Insulin Analogs]
  • Track the Capacity Expansion Projects: Co-ordinate with the stakeholders and ensure the program timelines are met.
  • Reporting : Status of the Capacity Expansion Projects to the Sr. Leadership team. (Escalations, if needed) Impact mitigation plan to be closely co-ordinated and aligned with the stakeholder
  • Facility Readiness for Audit: Liaise with the cross functional teams to identify the key open points and track the closures. Metrics to be reported to the site leadership team.
  • Manage all the New product and Market Launches for the products approved in Developed and Emerging markets.
  • Ensure the assessment completion for batch record, specifications and product shelf life in line with the approved dossier
  • Align and introduce the In-process and Finished product testing specifications for Drug substance and Drug product in line with the approved dossier for the respective new market
  • Plan and execute the change control approvals on time for the procurement of the Secondary packaging material for the respective market launch
  • Implementation of the specifications in Quality control for testing and release of the packaging materials
  • Liase with the site cross functional teams and Quality PMO : Ensure the quality metric systems [Change controls, Deviations and CAPAS] for each functional teams are tracked for closures and no overdues before the audit
  • Ensure the dash boards for all the programs are updated and status shared with the Executive leadership team with the Program Risks, Contingency Planning and Impact mitigation.
  • Facilitate the sample requests and the technical documents [Tech Transfer documents, Batch records, Method Qualifications, Validation and stability date readiness from Quality control units] for the dossier filings as per MoH and partner’s request in ROW markets
  • Budget: Track the Opex and Capex performance for the Operations team.

Please note: This is an onsite opportunity

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