Analytical Research Scientist-Peptide & Complex Injectable Testing

Department:

Job Purpose:

• Perform routine and non-routine analysis of peptide and complex injectable products using validated analytical methods.
• Execute testing for assay, impurities, related substances, dissolution (if applicable), pH, osmolality, clarity, particulate matter, water content, and other physicochemical tests.
• Operate and maintain analytical instruments such as HPLC/UPLC, LC-MS (if applicable), GC, UV-Vis, FTIR, KF, TOC, pH meter, and dissolution systems.
• Conduct method validation, method verification, and method transfer activities as per ICH and regulatory guidelines.
• Perform stability sample testing (long-term, accelerated, and ongoing) and ensure timely data generation.
• Ensure proper documentation of raw data, analytical worksheets, logbooks, and test reports in compliance with ALCOA+ and data integrity principles.
• Support investigations related to OOS, OOT, deviations, CAPA, and change controls.
• Assist in regulatory submissions by responding to DRA/agency queries related to analytical data.
• Follow GMP, GLP, EHS, and laboratory safety practices at all times.
• Participate in calibration, qualification, and preventive maintenance of analytical instruments.
• Support technology transfer and product lifecycle activities.
• Coordinate with cross-functional teams including Formulation, Manufacturing, QA, and Regulatory Affairs.

Qualifications

• M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry / Biochemistry or equivalent.
• B.Pharm / M.Pharm with relevant analytical experience may also be considered.

Experience

• 25 years of hands-on experience in analytical testing of injectable formulations, preferably peptides or complex molecules.
• Experience in a regulated pharmaceutical environment is mandatory.

Technical Skills

• Strong knowledge of peptide chemistry and complex injectable formulations.
• Hands-on experience with HPLC/UPLC method development and troubleshooting.
• Understanding of ICH guidelines (Q2, Q3, Q6), pharmacopeial requirements (USP/EP/IP), and regulatory expectations.
• Familiarity with electronic data systems, CDS (e.g., Open Office).

Behavioral & Soft Skills

• Strong analytical and problem-solving skills.
• Good written and verbal communication skills.
• Ability to work independently as well as in a team environment.
• High level of integrity, accuracy, and attention to detail.

Compliance & Quality Expectations

• Adherence to GMP, data integrity, and company SOPs.
• Timely completion of assigned activities with right-first-time approach.
• Readiness to support audits and inspections (internal, customer, and regulatory).

Best Regards,