Manager / Sr. Manager – F R & D- CDMO | Cipla | Mumbai

Role & responsibilities:

• Lead group of people for Formulation Development at CRO / CDMO / CMO development for the India Market
• Identify and select CDMO/CRO for product development and monitor the progress and launch of the product.
• Drive the IPD peers and product development & execution of development targets at CDMO / CMO / CRO
• Product and Progress improvement as and when required.
• Cost-effective development of the product to meet predefined targets.
• Evaluate alternate vendors for API / Excipients and Products as an when needed.
• Conduct due diligence for the finished product as per the requirement.
• Troubleshoot for all New Products, Existing Products, and scale-up batches at Manufacturing Site as and when required.
• Manage man powers in Formulation Development
• Manage Finance Budget
• Manage Quality requirements.
• Ensure end-to-end project delivery (from project development to filing/Launches) by designing and building quality with the help of various development tools.
• In the absence of Head Formulation Development, execution of the responsibilities of the Head Formulation Development
• Observance of the laid down standard operating procedures (SOP) in the Formulation Development Department, including Laboratory safety.
• Control of systems, laboratory area, equipment, instruments documentation, and personnel in the formulation development department
• Review of all the functions with Group Leaders.
• Review of allocation of work to formulators by the group leaders to ensure appropriate distribution of the work.
• Reviewing and updating specifications and systems to ensure compliance with statutory and company standards.
• Co-ordination with various departments as per the project requirement
• Monitoring execution of scheduled activities.
• Review of development pharmaceutics prepared by the formulators for the Indian market.
• Performance evaluation of the Group Leaders / Formulators
• Review of product documents prior to regulatory submissions
• Training for any new dosage forms/systems/technologies introduced.
• Involvement in technical discussions with suppliers/customers

Desired Candidate Profile:

Education Qualification

Master of Pharmacy

Relevant Work Experience

• Total Years of Experience: 10-15 years in FD + Product manager / FD + BD