Senior Process Chemist - Drug Supply

1d1 day ago

Novartis

Hyderābād, IN · Full-time · INR 3,000,000 – INR 5,000,000

About this role

We are looking for a highly motivated Process Chemist to manage early phase projects from GLP tox batches up to first-in-human API deliveries. You will closely collaborate with CDMOs in India and colleagues from other Novartis internal functions and sites. This role is part of the chemical and analytical development team in Genome Valley.

As a Process Chemist in the External Partner Management unit, you will guide external partners to plan, prepare, complete, and document chemical manufacturing meeting regulatory expectations. Supervise GMP activities including master batch record handling, deviation handling, and change control management. Support timely delivery of drug substance by reviewing technical and GMP-relevant documents.

You will report to the local team leader within the Global Drug Development team, ensuring highest quality small molecule drug substances for clinical trials. Actively manage interactions between internal and external partners for constructive collaboration. Participate in technical Drug Substance project team discussions to contribute to overall strategies.

Provide scientific guidance to external teams for daily business and troubleshooting, while supporting CMC document writing and regulatory submissions. Contribute to scientific exchange groups within Novartis and externally. Support set-up of databases, document flow processes, and onboarding of new external partners.

Requirements

PhD/Masters (M.Sc.) in synthetic organic chemistry with 8-12 years of hands-on scale up experience in the pharmaceutical industry in chemical development and GMP manufacturing
Proven hands-on experience in working in a GMP manufacturing environment and plants
Excellent knowledge of manufacturing plants & facilities and related documentations (tech transfer documents, BMR, deviation management, CAPA)
Successfully demonstrated expertise in scale up of drug substance from lab to plant
Proficient English (oral and written)
Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility

Responsibilities

Guide external partners to plan, prepare, complete and document chemical manufacturing within CDMO facilities meeting regulatory and health authorities' expectations
Supervise GMP manufacturing activities such as master batch record handling, deviation handling and change control management
Support external manufacture to ensure timely delivery of drug substance and reviewing technical and GMP-relevant documents
Provide scientific guidance to external manufacturing teams, supporting daily business, troubleshooting
Support CMC document writing and regulatory submissions
Actively manage interactions between internal and external partners to ensure constructive collaboration
Participate in technical Drug Substance project team discussions and contribute to overall strategies and goals
Support the set-up of databases and document flow process within the External Partner Management unit