General Manager Research Development
3 weeks ago
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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