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.