Executive / Sr executive - Analytical R&D (Biosimilars)

Role & responsibilities

1. Analytical R&D Biosimilars | Executive / Sr. Executive
   Company: MSN Laboratories
   Location: Pashamylaram, Hyderabad, Telangana
   Department: Analytical R&D – Biosimilars
   Experience: 2–7 Years
   Designation: Executive / Senior Executive
   Job Responsibilities

• Execute analytical development and characterization activities for biosimilar/biological products.

• Develop, optimize, qualify/validate, and transfer analytical methods for biologics.

• Perform physicochemical and structural characterization of recombinant proteins and biosimilars.

• Handle analytical techniques such as:

• HPLC/UPLC

• SEC-HPLC

• RP-HPLC

• Ion Exchange Chromatography (IEX)

• HIC

• CE-SDS

• icIEF / cIEF

• ELISA

• UV/Vis spectroscopy

• Protein concentration and purity assays

• Support characterization of primary structure, higher-order structure, purity, charge variants, aggregates, fragments, and post-translational modifications.

• Execute analytical experiments according to approved protocols and prepare accurate experimental records.

• Perform method development, optimization, robustness studies, validation/verification, and analytical method transfer.

• Support comparability studies between biosimilar candidates and reference/innovator products.

• Analyze experimental data, interpret results, and prepare technical reports.

• Support stability studies, forced degradation studies, and characterization studies.

• Investigate OOS/OOT and analytical discrepancies and support root-cause investigations.

• Coordinate with Process R&D, Formulation R&D, Quality Control, Quality Assurance, and Regulatory Affairs teams.

• Prepare and review analytical protocols, reports, specifications, SOPs, and other R&D documents.

• Support regulatory submissions and responses related to analytical development and characterization.

• Ensure compliance with GLP/GMP, data-integrity requirements, SOPs, and applicable regulatory guidelines.

• Technical Skills

• Strong hands-on experience in analytical characterization of biosimilars/biologics.

• Good understanding of protein chemistry and analytical techniques.

• Experience in chromatographic and electrophoretic techniques.

• Knowledge of ICH guidelines, QbD, method validation, analytical comparability, and stability studies.

• Experience with data interpretation, troubleshooting, and technical documentation.

• Exposure to advanced characterization techniques such as LC-MS/MS, peptide mapping, glycan analysis, intact mass, or bioassays will be an added advantage.

• Qualification

• M.Sc./M.Tech./M.Pharm./M.E. in Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline.

• 2–7 years of relevant experience in Analytical R&D, biologics, biosimilars, or protein characterization.

• Preferred Candidate Profile

• Candidates with hands-on experience in biosimilar analytical development/characterization.

• Good experimental and troubleshooting skills.

• Strong documentation and scientific-report-writing abilities.

• Ability to independently execute analytical experiments and interpret data.

• Good communication and cross-functional coordination skills.

• Experience working in a regulated R&D/GMP environment is preferred.