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

Biopatrika; Pune District; Vor Ort; INR 1.200.000 - 2.500.000; Vollzeit

Zusammenfassung

Biopatrika in Pune is hiring for Research Scientist / Sr Research Scientist – ADL, Genotoxic impurities, analytical testing lab. Location: Chakan Industrial Area, with 2–5 / 5–8 years experience, MSc/MTech/MPharm (Analysis/Chemistry).

The role covers method development, validation, regulatory documentation, and leadership of project teams. Responsibilities include handling LC-MS/MS, GC-MS/MS, HPLC and other high-end hyphenated techniques, ensuring data integrity, and supporting global

Qualifikationen

• Experience in analytical method development & validation for GTIs/NDSRIs/nitrosamines.
• Ability to perform forced degradation studies and mass balance assessments.
• Regulatory compliance with ICH M7, ICH Q3A/B/D, USFDA, EMA, ANVISA, PMDA.
• Prepare, review, and approve method development reports, validation protocols/reports, SOPs, and impurity risk dossiers.

Aufgaben

• Design, develop, and validate highly sensitive trace-level analytical methods (LC-MS/MS, GC-MS/MS, HPLC, GC-HS).
• Establish TTC-based specifications and quantification limits for target analytes.
• Oversee data acquisition, peak integration, and mass spectral interpretation for impurity profiling.
• Maintain software compliance and 21 CFR Part 11 data integrity across ELNs/LIMS.
• Lead cross-functional project teams and mentor junior scientists.

Kenntnisse

Analytical method development

Validation

Mass spectrometry interpretation

Data integrity

Ausbildung

M.S./M.Tech./M.Pharm (Analysis/Chemistry)

Tools

LC-MS/MS

GC-MS/MS

HPLC

GC-HS

ICP-MS

HRMS

Jobbeschreibung

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)

• 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.