Research Scientist/ Sr Research Scientist – ADL, Genotoxic impurities – Analytical testing laboratory working for global markets (03 Vacancies)

Job Description

We are Hiring!!! Position: Research Scientist/ Sr Research Scientist – ADL, Genotoxic impurities – Analytical testing laboratory working for global markets (03 Vacancies) Department: Analytical Method Development & Validation, Regulatory Compliance & Technical Documentation & Instrument Operations & Advanced Hyphenated Techniques Experience: 2 – 5 / 5 – 8 years Location: Chakan Industrial Area, Pune, Maharashtra, India Qualifications: M.Sc/M.Tech/M.Pharm (Analysis/Chemistry) Interested candidates can share their resume at sreddy@bachwellpharma.com (main mail ID) , hr@bachwellpharma.com, bachwellpharma@gmail.com Core Job Responsibilities Analytical Method Development & Validation Design, develop, and validate highly sensitive trace-level analytical methods (LC-MS/MS, GC-MS/MS, HPLC, GC-HS) for identifying and quantifying mutagenic and genotoxic impurities (GTIs/NDSRIs/nitrosamines) down to ppm/ppb levels. Establish threshold of toxicological concern (TTC) based analytical specifications and target analyte quantification limits in compliance with global standards. Perform forced degradation studies and mass balance assessments to evaluate degradation pathways and impurity profiles. Regulatory Compliance & Technical Documentation Ensure strict compliance with global regulatory guidelines, including ICH M7, ICH Q3A/B/D, USFDA, EMA, ANVISA, and PMDA.

Prepare, review, and approve method development reports, validation protocols/reports, standard operating procedures (SOPs), and impurity risk assessment dossiers.
Address technical queries and audit observations from international regulatory agencies and global client quality units.
Instrument Operations & Advanced Hyphenated Techniques Operate, troubleshoot, and maintain high-end hyphenated analytical instruments (e.g., LC-MS/MS, GC-MS/MS, ICP-MS, HRMS).
Oversee data acquisition, peak integration, and mass spectrometry spectral interpretation for trace-level impurity structure elucidation.
Maintain software compliance and 21 CFR Part 11 / ALCOA+ data integrity standards across all electronic laboratory data systems.
Project & Laboratory Leadership (Asst. Manager Level) Lead cross-functional project teams to deliver analytical testing projects within client-agreed timelines and budgets. Drive root-cause analysis (RCA) and lead investigation of Out of Specification (OOS), Out of Trend (OOT), and atypical results during method transfer or routine batch release.
Mentor junior scientists, conduct technical training on mass spec instrumentation and GTI chemistry, and manage resource allocation for high-throughput testing. Coordinate with business development and client-facing teams to scope analytical requirements for global pharmaceutical clients.