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.