Research Scientist - Analytical Development Laboratory

Probus Standards; Ahmedabad District; On-site; INR 600,000 - 1,200,000; Full time

Benefits offered by this job

NABL exposure

ISO quality systems

Job summary

Probus Standards invites an experienced analytical chemist to lead quality control testing of CRMs and to design stability studies in a NABL-accredited facility in India. You will perform method validation per ICH guidelines, ensure traceability, and support CoA preparation with robust data integrity practices.

The role requires strong instrumentation skills (HPLC, LC-MS, GC-MS, FT-IR, UV-Vis, KF, TGA) and proficiency in data analysis, reporting, and SOP maintenance within ISO/IEC 17025/17034

Qualifications

• Mandatory postgraduate degree in Analytical Chemistry or equivalent.
• Hands-on experience in pharma QC/R&D testing laboratories.
• Strong knowledge of ICH QA guidelines and ISO quality systems.

Responsibilities

• Perform analytical testing of CRMs for quality attributes using HPLC, LC-MS, GC-MS, FT-IR, UV-Vis, KF, and TGA.
• Design and review homogeneity, stability studies, and shelf-life assignments per approved protocols.
• Ensure metrological traceability and calibration strategies; evaluate measurement uncertainty.

Skills

Analytical Chemistry

Method Validation

Measurement Uncertainty

English Communication

Education

M.Pharm or M.Sc in Analytical Chemistry

Tools

HPLC

LC-MS

GC-MS

FT-IR

UV-Vis

KF (Karl Fischer)

TGA

Job description

Role & responsibilities

• Perform analytical testing of CRMs for property value assignment, purity, identity, assay, and related substances using HPLC, LC-MS, GC-MS, FT-IR, UV-Visible spectrophotometry, moisture content by Karl Fischer (KF), and inorganic content by TGA
• Execute and review homogeneity and stability study designs, statistical evaluations, and shelf-life assignment of CRMs as per approved protocols
• Ensure metrological traceability of all measurements; approve calibration strategies, reference standard sourcing, and measurement uncertainty calculations
• Perform analytical method validation/verification (specificity, linearity, accuracy, precision, LOD, LOQ, robustness) per ICH Q2(R2)
• Calculate assigned values and evaluate measurement uncertainty; generate and review analytical data and technical reports supporting Certificate of Analysis (CoA) preparation
• Generate, review, and maintain analytical data with complete traceability per ISO data integrity principles
• Maintain and periodically review SOPs, test methods, specifications, and controlled documents under the quality management system
• Maintain system suitability, instrument logbooks, and calibration records; oversee instrument qualification (IQ/OQ/PQ), preventive maintenance programs, and vendor management for analytical equipment
• Ensure laboratory operations comply with ISO 17034, ISO/IEC 17025, data integrity, GLP/GMP, and applicable ISO requirements
• Evaluate non-routine test methods, non-conformities, and root cause analyses
• Lead non-conformity handling, corrective action implementation, change control, and risk-based decision making within the testing function
• Participate in internal audits, proficiency testing, inter-laboratory comparisons, method performance monitoring, and internal quality check programmes such as blind testing and replicate testing as per ISO 17025 requirements

Preferred candidate profile

Requirements

• M.Pharm or M.Sc in Analytical Chemistry from a recognised university (mandatory for this role); alternatively B.Sc (Chemistry) with 79 years of progressive analytical experience
• 46 years of hands-on experience in an analytical laboratory (pharma QC, R&D, or testing lab)
• Strong proficiency in HPLC (mandatory); working experience with LC-MS, GC-MS, FT-IR, UV-Vis, KF and TGA
• Experience with analytical method validation per ICH guidelines
• Knowledge of measurement uncertainty evaluation and statistical data analysis
• Familiarity with ISO/IEC 17025 or ISO 17034 quality systems is a significant advantage
• Experience with non-conformity handling and corrective action implementation processes
• Ability to review and author SOPs, test methods, and technical reports
• Strong communication skills; professional proficiency in English
• Willingness to work at our Changodar (Ahmedabad) laboratory facility

What We Offer

• Opportunity to be part of a pioneering organisation in Indias CRM industry early team members will play a foundational role in the company’s growth
• Direct exposure to NABL-accredited laboratory operations and ISO 17025/17034 quality systems
• Hands-on, high-responsibility role from day one no waiting years for meaningful work
• Clear career growth path as the company scales
• Supportive, small-team environment with direct access to leadership