PI Health Sciences | General Manager Research Development | hyderabad

4 weeks ago


hyderabad, India PI Health Sciences Full time

Educational Qualification

Ph.D. in Chemistry from Top Reputed University & Post Doctoral Fellowship with a strong focus on organic synthesis


Experience

Minimum of 15-20 years of experience in CRO/CDMO pharmaceutical process research and development, with a proven track record of successfully leading and managing teams


Industry to be hired from

Preferably CRO/CDMO only, No API experience.


Job Description:


Strategic

Develop and implement a strategic vision for the PR&D department aligned with organizational goals. Provide guidance on innovative approaches to process development and optimization.


Operational

  • Lead and coordinate multiple projects simultaneously, ensuring timely delivery of high-quality results. Collaborate with project teams to define objectives, timelines, and resource requirements.
  • Ensure timely preparations of budget for process research & development operations and put forward the same to the Chief Scientific officer.
  • Effectively present information to CSO & senior management on issues in the process development along with recommendations on the next steps.
  • Ensure maintenance of appropriate documentation at various stages of process development to ensure proper preparation and submission of comprehensive product files toward clinical testing and registration.
  • Direct the conduction of model formulation studies to help select appropriate excipients and processes.
  • Maintain a contemporary awareness of Global Business Practices, Pharmacopeial trends, ICH guidelines and regulatory expectations.
  • Oversee the design, optimization, and scale-up of chemical processes for the synthesis of pharmaceutical compounds. Implement novel technologies and methodologies to enhance process efficiency.
  • Facilitate the seamless transfer of processes from the laboratory to manufacturing, ensuring a smooth transition and alignment with client specifications and quality standards.
  • Maintain a thorough understanding of regulatory requirements and ensure that all processes developed and transferred comply with applicable regulations. Collaborate with quality assurance and regulatory affairs teams as needed.
  • Manage departmental resources, including personnel, budget, and equipment, to optimize efficiency and productivity. Identify opportunities for improvement and implement best practices.


Customer

  • Act as a key point of contact for clients, addressing their technical queries, providing updates on project progress, and ensuring client satisfaction.
  • Collaborate with business development teams to support proposal development and client acquisition.



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