General Manager ( R&D )

Role & responsibilities

1. To lead and manage the entire gamut of Research & Development activities including both Formulation development and Analytical development functions.

2. To propose new projects, design, execute development activities, timely completion of robust formulations and processes development followed by technology transfers.

3. Responsible for development of All types of Pharmaceutical dosage forms. Should be accountable for Literature search, pre-formulation, formulation design, and development of stable, bioequivalent and manufacturable generic solid orals, liquid orals (Tablets, Capsules, Syrups & suspensions), topical formulations, injectables with unique exposure to drug delivery and packaging systems & pallets.

4. Develop robust formulations and processes for immediate release and modified release Tablet and capsule dosage forms.

5. Responsible for working with cross-functional departments such as Manufacturing, QA, QC, R&D, Regulatory Affairs for smooth transfer of scientific data and technology to the manufacturing site for execution of Exhibit batches and take it to the commercialization stage.

6. Manage to provide required documentation to RA in a timely manner to support regulatory filings and support in clearing the regulatory queries from various regulatory agencies so that we do not cross the timelines.

7. Evaluate patents and develop non-infringement strategies.

8. Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines.

9. Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose for all the markets like regulated & emerging countries.

10. He should have a hands on exposure to conceptualizing, development of Nutraceuticals, Wellness and Novel FMCG Products, their registrations with FSSIC and FDA`s.

11. The desired candidate should have a knack of attending and trouble shooting at manufacturing stages of products.

12. Responsible for an Analytical team involved in Method development, Method Transfer and Validation for various stages of drug development.

13. Method Validation of analytical methods as per internal and country specific regulatory guidelines and execution through proper protocols.

14. Responsible for reviewing and approving analytical data as per regulatory requirements.

15. Effective method development ensures that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development.

16. Responsible for ensuring delivery time-lines and adherence to quality standards.

17. Facilitating scientific and technical discussions with team members and external collaborators to resolve issues and communicating conclusions from stability studies.

18. Demonstrated experience in designing and writing stability protocols for investigational or registration studies, analyzing and trending large sets of data.

19. Jenburkt Research center having accreditation from Govt Of India , The candidate is expected to liaise with DSIR for annual reporting and other queries.

Preferred candidate profile

20 + experience in pharmaceuticals FORMULATIONS.

Qualification Ph D in pharmacy, or PhD in organic chemistry however , with a strict vast exposure in pharma FORMULATIONS.

Excellent communicator with equally good people management skills.