Senior Manager

Department Research and Development

Purpose of the Role: To participate in R&D projects or development activity to meet

organizations requirement.

Knowledge Required

1. Ph.D. in Organic Chemistry from a reputed university.

2. More than 05 years of industrial experience in API R & D from a reputed pharma company.

3. Have adequate knowledge of Regulatory requirements DMF preparation and regulatory filings.

4. Ensure the proper documentation practices report preparation and the ability to present the development activities

5. Have the ability to work with multiple projects and timely deliverance.

6. Worked for process improvement cost reduction vendor approval plant troubleshooting and Investigation of failures

7. Sound knowledge of IPR regulatory filing requirements Genotoxic impurities NNitroso impurities identification and control requirements

8. Ability to design noninfringing costeffective & scalable synthetic routes.

9. Scientific knowledge of developing robust and safe processes for desired quality API.

10. Current Good Laboratory Practices.

11. Awareness of Laboratory Safety.

12. Purge studies for specification fixation of key starting materials intermediate and Raw materials.

13. Endtoend product development cycle from lab scale to commercial Scale.

14. Thorough understanding of critical process parameters.

• Must have

Educational Qualification M. Sc. (Organic Chemistry) Ph. D

Experience in (In Years): 12 15 Years

Technical Skills and Abilities:

1. Evaluation of lab experiment results along with the team.

2. Documentation support for technology transfer.

3. Evaluation of literature on given target molecules.

4. Monitoring the scaleup activities.

5. Support on drug master fillings.

Behavioural Skills and Abilities:

1. Planning and monitoring of daily lab experiments.

2. Creation of a safe work environment in the laboratory.

3. Leading and guiding team members towards the achievement of project deliverables.

Nice to Have:

1. Ability to understand the analytical results and specifications as shared by the analytical R&D

team.

2. Knowledge of Process analytical technology tools used during optimisation.

3. Coordination with the manufacturing process engineering and quality team.

4. Evaluation of costing and scalability of processes.