POSITION - AVP (Head R&D) - API (Steroids and Hormones)

QUALIFICATION - Ph.D. in organic chemistry

EXPERIENCE - More than 20 years of experience in API development for regulated, semi regulated and non-regulated markets with excellent delivery track records. Experience in steroids and hormones is preferred.

CTC RANGE - 40.00 LPA

JOB DESCRIPTION - Set daily, weekly, monthly, quarterly targets for the department and monitor the progress

on timely basis.

2. Assess product costing during course of development till validation to achieve the target

costing through process design and efficiency.

3. Involve in identifying right source for key Raw materials.

4. Guide API team on critical decision pertaining to route of synthesis selection using

appropriate technology basis product type and target cost.

5. Undertake Cost Leadership projects as per business need for various markets (US/ EU/ROW).

6. Ensure project progress as per timelines along with various cross-functional teams for product development, filing, validation and commercialization.

7. Monitor portfolio to ensure communication on Project, its status, critical path activities, resource requirements and risk mitigation strategy.

8. Guide R&D team to Identify areas of improvement in the new product development and existing commercialized processes with the objective of “increasing throughput, reducing

the steps, recovering and recycling of solvents, minimizing waste, effluent generation, reducing cycle time, and improve process yield, and RM consumption/ adopt low cost RM’s, by an using an appropriate scientific approach and design principles.

9. Guide R&D team on critical decision pertaining to route of synthesis selection using appropriate technology basis product type and target cost.

10. Develop a strategy that would lead to green chemistry.

11. Enable and ascertain timely release of PDR for plant validation for new DMF filing (Tech Packs) and cost improvement process PDR/Addendum for variation filing.

12. Ensure adherence to day to day planning and execution of lab activities.

13. Support the trouble shooting activity for plant batches in timely manner.

14. Support supply chain to identify good vendors through quality assessment and provide

appropriate documents those meets quality/regulatory/safety needs.

ADL (Analytical Development):

1. Guide ADL team to develop robust methods for APIs, intermediates, IPCs, RM and other

related analysis.

2. Ensure timely completion of analytical method development, method validation and method transfer.

3. Guide ADL and validation teams to address customer/ regulators’ queries and ensure timely completion of the required activities.

4. Ensure execution of day to day plan and desired outcome from ADL.

5. Support for third party analysis.

Contact No & WhatsApp - 9737979902

Mail ID - hiring@bigpharmajobs.co.in/ workfromhome.virendra@gmail.com