Date PostedAugust 19, 2023
Location (State / UT)
Expiration dateMarch 11, 2024
Experience8 Years, 13 Years
Desired QualificationMaster’s Degree
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:
Master of Pharmacy
Relevant Work Experience
- Total Years of Experience: 10-15 years in FD + Product manager / FD + BD