Research Scientist _ CMC & NPR

Job Description – Senior Scientist (CMC):

Role Summary:

Senior Scientist responsible for API/NCE process development for regulated and semi‑regulated markets, with strong involvement in non‑infringing route design, scale‑up, regulatory filings, and cost‑effective technology transfer from lab to plant.

Key Responsibilities:

· Directed a team of five scientists, including PhDs, for API/NCE process development in regulated and semi‑regulated markets.

· Executed API/NCE process development activities from literature search through scale‑up and commercialization.

· Performed literature and patent searches to design non‑infringing, scalable synthetic routes.

· Supported process optimization, validation, and exhibit batch preparation for DMF filings.

· Conducted preliminary process feasibility and cost evaluations to achieve the targeted RMC.

· Supported lab‑to‑plant technology transfer and participated in plant‑level process validation.

· Carried out and documented impurity synthesis, characterization, and impurity carryover studies.

· Assisted in genotoxic impurity risk assessment and implementation of control strategies.

· Supported the preparation of Process Development Reports (PDRs) and regulatory documentation.

· Addressed regulatory and customer queries related to generic APIs.

· Contributed to cost‑reduction initiatives through yield improvement, step reduction, and solvent recovery optimization.

· Worked collaboratively with cross‑functional teams to meet project timelines and quality requirements.