CLIENT: Leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry’s chemistry needs. This organisation has a presence in over 80 countries with more than 75% of revenues accounted for by exports.US and Europe are key markets, accounting for 70% of total revenues.

KEY DELIVERABLES

- Lead R&D; CRO projects for global customers including development of non-infringing routes for API’s with sustainable processes including Impurity synthesis.
- Develop robust, scaleable, operationally protected and commercially viable processes including synthesis route selection, lab feasibility, process optimization, technology transfer and scale up & commercialization for the tonnage scale campaigns, keeping close eye on safety and quality.
- Head team of R&D; scientists (M.Sc./PhDs) for Process development by QbD/DoE approach and validations, end to end troubleshooting, cost reduction and technology transfer activity, first to file product filings.
- Regulatory filing of the API’s and regulatory deficiency response of API’s.




- Ensure Vendor qualification requirements for procuring KSM’s, reagents and advance intermediate and Investigations (OOS & OOT) and CAPA implementation, change controls.
- Cross functional engagement (QA, QC, production, and regulatory department).

Incumbent profile

- Phd Chemistry with 15+ years experience and proven track record of excellence and productivity in the CRO / CMS space of process R&D; experience.
- Highly experienced and proficient in the field of Organic Process R&D; in CRO/CMO (Early and Late Phase NCEs).
- Hands on experience with range of laboratory instruments, purification techniques and PAT tools (e.g. NMR, Microwave reactor, flash, RP-HPLC & FTIR, FBRM), and interpretation of DoE experimental data using Design expert & Minitab.
- Working knowledge in most of the chemical databases, Scifiender, Reaxys, Chemdraw, MNova.,

ANNUAL COMPENSATION: 25LPA

Queries:

Anoop Sinha, CEO, PROFILE HR CONSULTANTS PVT LTD

Cell-(phone hidden)

📌 AGM API Research ( Phd Only) (Hyderabad)
🏢 Edinburgh
📍 Hyderabad