Title:  Senior Manager - FRD Non Orals

Job Title:

Senior Manager – Formulation Research & Development – Non Orals (Orally Inhaled and Nasal

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G9B/A

Location

Baroda

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?  As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Description:

1. To prepare & execute formulation development plan/strategy based on literature/patents.
2.  To design pre-formulation and prototype experiments and to monitor batches prepared for stability studies, method development & validation.
3. To review/approve documents for import of API/Innovator sample and for manufacturing license for examination, testing & analysis of drug products.
4. To ensure procurement of raw material (API/Excipients), packing material & innovator samples in consultation with packing/Purchase department.
5. To evaluate Innovator pack details and review Innovator procurement quantity with justification.
6. To review experimentation details in Log book/ELN.
7. To review/approve product development protocol & report for different development studies.
8. To review/approve test request for analysis of raw material (API/Excipients) & drug product.
9. To review/approve stability protocol & report.
10. To prepare budget of assigned project.
11. To review/approve tech-transfer documents (e.g. Sheet II, MF, RA, FMEA, stability plan, scale-up report & SDS).
12. To supervise scale up /exhibit /clinical batches at plant/CMO.
13. To review/approve documents required for regulatory submission for all markets & to review/approve technical reports/scientific justification to respond regulatory queries.
14. To use different applications introduced by management as a part of IT enablement.
15. To participate in different management initiatives like PACE, Kaizen & process excellence
16. To compile data & prepare presentation for project update.
17. To review in-process & finished product specification.
18. To review/approve narcotics & psychotropic substance related documents (If used).
19. To review/approve SOPs for laboratory equipment/instrument.
20. To ensure compliance of internal quality system.
21. To evaluate drug product robustness & stability using statistical tools.
22. Co-ordination with cross-functional team, vendor & third party/CMO.
23. To review/approve troubleshooting/investigational reports for failures/OOS/OOT.
24. To attend various training programs as per IDP.

NA

Job Requirements

Educational Qualification

Graduate : M.Pharm / PhD

Experience

Tenure : Minimum 15 years of relevant experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).