Senior Scientist_ Peptide Analytical Development - Chennai

BVR People Consulting; Chennai; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

A confidential pharmaceutical client in Chennai seeks a Senior Scientist Analytical Development (Peptides) to lead analytical development for peptide substances. This role focuses on developing and validating peptide analyses and supporting regulatory filings.

You will collaborate across Synthesis, Process Chemistry, Formulation, and QA, driving method development and technology transfer, while ensuring GMP and regulatory compliance. This is an on-site Chennai position with global collaboration.

Qualifications

• Extensive experience in peptide analytical development and method validation.
• Experience with HPLC, LC-MS/MS and HRMS for peptide analysis.
• Familiarity with regulatory guidelines (ICH, GMP) and GMP compliance.
• Experience in tech transfer to manufacturing/CDMOs and stability studies.
• Ability to handle OOS/OOT investigations and CAPA.

Responsibilities

• Collaborate with peptide synthesis, process chemistry, formulation development, and QA teams.
• Develop, optimize, and validate analytical methods for peptides.
• Apply HPLC, UPLC, LC-MS/MS, HRMS, NMR, and CD spectroscopy for peptide analysis.
• Support scale-up, tech transfer to manufacturing sites/CDMOs, and stability studies.
• Prepare and review analytical sections of regulatory submissions and respond to regulatory queries.
• Ensure compliance with ICH, USP, EP, GMP, and global regulatory requirements.
• Handle OOS/OOT investigations, change controls, and root-cause analysis.

Skills

Peptide Analytical Development

Peptide API

HPLC

UPLC

LC-MS/MS

HRMS

NMR

SPPS

LPPS

Method Development

Method Validation

GMP

ICH Guidelines

OOS/OOT

Tools

HPLC systems

LC-MS/MS systems

NMR spectrometer

CD spectrometer

Regulatory documentation tools

Job description

Dear Candidate,

We are hiring for an exciting opportunity in Peptide Analytical Development with a leading pharmaceutical company based in Chennai.

About the Company

Our client is an established pharmaceutical company engaged in the development and manufacturing of pharmaceutical products, with a focus on quality, innovation, and regulatory compliance. The company name is confidential at this stage and will be disclosed during the recruitment process.

Position

Senior Scientist Analytical Development (Peptides)

Location

Chennai

Job Responsibilities

• Collaborate with peptide synthesis (SPPS/LPPS), process chemistry, formulation development, and Quality Assurance teams.
• Develop, optimize, and validate analytical methods for raw materials, intermediates, and final peptide drug substances.
• Apply HPLC, UPLC, LC-MS/MS, HRMS, NMR, and CD spectroscopy for peptide analysis and characterization.
• Support scale-up, technology transfer to manufacturing sites/CDMOs, and stability studies.
• Prepare and review analytical sections of regulatory submissions and respond to regulatory queries.
• Ensure compliance with ICH, USP, EP, GMP, and global regulatory requirements.
• Handle OOS/OOT investigations, change controls, and root-cause analysis.

Key Skills

Peptide Analytical Development, Peptide API, HPLC, UPLC, LC-MS/MS, HRMS, NMR, SPPS, LPPS, Method Development, Method Validation, GMP, ICH Guidelines, OOS/OOT.