Senior Scientist responsible for API/NCE process development for regulated and semi‑regulated markets, with robust 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.
Job Snapshot Updated Date 20-04-2026 Job ID JOB10569 Division ZRC CHEMISTRY Location R&d; - Zrc|zrc - Ahmedabad, Ahmedabad, Gujarat, India Experience 0 - 10 Years Employee Type C-C6-Confirmed-R&D; Executive
📌 Research Scientist _ CMC & NPR (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad
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