Research Scientist/Senior Research Scientist - Analytical Developement

Sentiss Pharma Pvt. Ltd.; Gurugram District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sentiss Pharma Pvt. Ltd. invites applications for an analytical chemist to develop and validate methods for testing product formulations, finished products, raw materials, and APIs using HPLC/UPLC/UV/GC/IC, among others.

The role involves report preparation, method transfer, and coordination of external analyses. MD/Analytical Chemistry with 3–10 years of experience is required; MSc in Analytical/Chemistry is preferred.

Qualifications

• 3–10 years of experience in analytical method development and testing.

Responsibilities

• Develop and validate analytical methods for testing products and materials using HPLC/UPLC/UV/GC/IC and related techniques.
• Prepare method development reports, validation/verification protocols, specifications, STPs, and COAs.
• Perform analysis of raw materials, APIs, and excipients and finished products.
• Prepare method transfer sheets and transfer methods to plant QC.
• Coordinate outside analyses for Q3 studies (XRD, Raman, DSC, TGA, SEM, TEM).
• Review DMFs and conduct literature searches to support method development.
• Prepare and update SOPs; calibrate and maintain analytical instruments.
• Follow good documentation practices and operate in compliance with cGLP.
• Handle any other responsibilities assigned as required.

Skills

Analytical method development

Documentation

Regulatory compliance

Laboratory planning

Analytical problem solving

Education

M.S. in Analytical Chemistry

Tools

HPLC

UPLC

UV

GC

XRD

Raman

DSC

TGA

Job description

• Develop and validate analytical methods for testing of product formulations, finished products, raw materials, and APIs using techniques such as HPLC/UPLC/UV/GC/IC, Dissolution, Particle Size Analyzer, Zetasizer, Viscosity, Surface Tension, and wet chemical methods.
• Prepare method development reports from developmental trials, method validation/verification protocols and reports, Specifications, STPs, and Certificates of Analysis from routine analysis and vendor documents.
• Perform analysis of raw materials, APIs, and excipients as per Pharmacopoeial/vendor methods, including analysis of routine and stress samples of finished products.
• Prepare method transfer sheets and transfer analytical methods to plant QC.
• Coordinate outside analysis related to Q3 studies such as XRD, Raman, DSC, TGA, SEM, TEM, etc.
• Review drug substance DMFs and conduct literature searches to support method development.
• Prepare and periodically update relevant SOPs; perform calibration and maintenance of analytical instruments in the laboratory.
• Follow good documentation practices and perform all analytical activities in compliance with cGLP.
• Handle any other responsibilities assigned as required.

Experience Required: 3–10 years

(Designation will be offered based on candidate's experience and skill set)

Qualification Required - M.Sc (Analytical/Chemistry)