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Director- Formulations Pilot Plant Head
LOCATION

Hyderabad, India

DEPARTMENT

Formulations

Responsible for heading the FR&D team, end to end Formulation, Process development, Scale Up, Tech Transfer of generic and NCEformulations for global market.

Responsibilities –Meet Strategic Objectives 

  • Provide strategic inputs to BU head for Formulation function/Pilot Plant for formulation development and manufacturingactivities
  • Implement the approved business plan in formulation area and pilot plant
  • Co-ordination with Business Development team in new product selection, R&D feasibility evaluation, arriving at developmentstrategies, costing evaluation and project proposals to management and clients.Client Management
  • Co-ordinate with clients for strategic planning and project management, timelines, and execution of projects as per thedefined projects proposals
  • Identify the actions need to be taken in order to improve working relations with other Support team members in closing identifies gaps to improve client satisfaction score
  • Understand the dynamics of conflicts and take actions to either avoid or minimize its impact on the meetingEnhance scientific and execution capability
  • Provide scientific leadership especially for smooth execution and leading Formulation Research and Development departmentfor the development of generic formulations and NCE formulations for global markets, scale up, Technology transfer, processdevelopment, exhibit batch manufacturing and commercial launches.
  • Project feasibility assessment, Identify and mitigate risks. Review work/projects periodically with project managers againstproject plan and timelines as per client requirements.
  • Ensure ecosystem for teams in terms of infrastructure, equipment/instruments etc in a cost effective and optimum manner
  • Collaborate and influence internal stakeholder/other departments (e.g. AR&D, internal API development teams, BD, PM, HR,IT, Admin, Maintenance etc.) to provide required resources/services
  • Guiding the team in formulation studies, Proof of Concept studies, QbD based product development and preparation of filingdocuments viz. PDR/QoS for regulatory submission
  • Planning and co-ordination with cross functional teams for the BENOC applications, CRO selections, scheduling of BE studies,review of reports and concluding on bioequivalence at pilot & Pivotal stage. 
  • Tracking of project plans, monitoring & control of critical chain tasks.
  • Review of R&D documents (MFR, BMR, TTD, Process Validation report, Product Development report, QbR & QoS) forregulatory agencies on filed products. 
  • Seamless transfer of R&D technology to manufacturing units for scale up/submission batches.
  • Monitoring of trouble shooting activities of commercialized products at R&D and manufacturing site; proposals for betterformulation and process.
  • Evaluation of new scientific technologies and concepts, procurement of new equipment at R&D. 
  • Implementation of new SOPs, check lists, periodic revision of SOPs and monitoring of team adherence to established systems.Ensure high morale and skill development for self and team.
  • Inspire, motivate, hire and retain right talent.
  • Drive culture of self - development in team.
  • Develop, mentor and coach the team members.
  • Drive high performance culture, recognize best performers through various rewards & recognition programs Career management of teams.
  • Foster a learning environment and plan developmental programs 
  • Identify and develop second in line managers.
  • Responsible for employee satisfaction score Continuously update self on industry trends Ensuring team adhering to company values and behaviours and be the role model
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