15.0 - 19.0 years

0 Lacs

hyderabad, telangana

On-site

As a key member of the team at a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry, your primary responsibilities will include leading R&D CRO projects for global customers. You will be tasked with developing non-infringing routes for APIs with sustainable processes, focusing on Impurity synthesis. Additionally, you will play a crucial role in developing robust, scaleable, operationally safe, and commercially viable processes. This includes synthesis route selection, lab feasibility, process optimization, technology transfer, and scale-up & commercialization for tonnage scale campaigns, always prioritizing safety and quality. You will lead a team of R&D scientists, overseeing Process development using the QbD/DoE approach and validations. Your expertise will be instrumental in end-to-end troubleshooting, cost reduction, technology transfer activities, and first-to-file product filings. Furthermore, you will be responsible for the regulatory filing of APIs and addressing any regulatory deficiencies that may arise. In your role, you will ensure that vendor qualification requirements are met for procuring Key Starting Materials (KSMs), reagents, advanced intermediates, and Investigations (OOS & OOT). You will also be involved in CAPA implementation and change controls, necessitating cross-functional engagement with QA, QC, production, and regulatory departments. As the ideal candidate for this position, you will hold a Ph.D. in Chemistry with over 15 years of experience in the CRO / CMS space of process R&D. Your proven track record of excellence and productivity will be demonstrated through your experience in Organic Process R&D in CRO/CMO, particularly in Early and Late Phase NCEs. Proficiency in utilizing a range of laboratory instruments, purification techniques, and Process Analytical Technology (PAT) tools such as NMR, Microwave reactor, flash, RP-HPLC, FTIR, and FBRM will be essential. Additionally, your ability to interpret Design of Experiments (DoE) experimental data using tools like Design Expert & Minitab will be highly valued. Working knowledge of chemical databases like Scifinder, Reaxys, Chemdraw, and MNova will also be advantageous. If you are seeking a challenging opportunity in the pharmaceutical industry and are looking to be compensated in the range of 25-30 LPA annually, we encourage you to apply for this exciting role. For further information or to express interest in this position, please reach out to Anoop Sinha, CEO at PROFILE HR CONSULTANTS PVT LTD, at 9773520069.,

Posted 1 week ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.