Vice President

2 months ago

Bengaluru, India Strides Full time

Strategic:

  • Develop a global technology and Site-transfer strategy by working closely with the Head, R&D, Head, Operations, Head, Quality and other leadership roles; periodically review the same by aligning with global best practices

Operational

  • Oversee development of technology transfer / Site-transfer plans for each of the operating domains for Strides by working with Heads of FD and Head, Operations / Senior Plant Heads and New Product Introduction Group
  • Oversee development of checklists to anticipate feasibility or implementation issues for drugs in the R&D stage, based on in-depth understanding of the manufacturing process and facilities
  • Develop risk charter for Technology / Site-transfer in association with the Risk Management Team and oversee detailing of the same for all operating domains
  • Provide guidelines on supervision of batch sizes, scale up trials and validation support of the manufacture process, in line with regulatory and EHS requirements
  • Identify production requirements associated with first-time drugs / formulations and work with the Global Head, F&E and concerned Plant Heads to ensure availability of equipment, resources and skills to enable manufacture of the drug; suggest action plans to manage transfer of site / technology if resources are absent
  • Liaise with senior counterparts from partner / client organizations to facilitate smooth technology / Site-transfer
  • Develop norms around documentation to ensure thoroughness and standardization of information gathering and presentation, across domains and locations
  • Provide guidelines on constitution of Tech Transfer teams for different scenarios and work with Heads of all concerned teams to ensure adequate representation and contribution in Technology / Site-transfer Cross Functional Teams (CFTs)
  • Act as the final point of escalation for any technology / site-transfer issues, including activity planning and scheduling
  • Oversee development of knowledge management tools to ensure that learning from tech-transfers / site-transfers are codified and shared with concerned stakeholders
  • Develop and oversee implementation of contingency mechanisms to manage errors in the Tech / Site-transfer process based on time-bound root cause analysis

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