05 Aug
|
Zydus Group
|
India
- Job Description – Senior Scientist (CMC):
Role Summary:
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 (India)
🏢 Zydus Group
📍 India