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

MSN Group; Hyderabad; On-site; INR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

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Job summary

MSN Laboratories in Hyderabad seeks an Analytical R&D Executive/Sr. Executive to drive analytical development and characterization for biosimilars.

You will develop, validate, and transfer methods, perform physicochemical and structural characterization, and support regulatory submissions in a GMP/GLP environment. Role requires hands-on chromatography/electrophoresis, protein chemistry knowledge, and experience with LC-MS/MS or glycan analysis.

Qualifications

• M.Sc./M.Tech./M.Pharm./M.E. in Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline.
• 2-7 years of relevant experience in Analytical R&D, biologics, biosimilars, or protein characterization.

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.

Skills

Analytical characterization

Protein chemistry

Chromatography

Electrophoresis

ICH guidelines

Method validation

Data interpretation

LC-MS/MS

Glycan analysis

Bioassays

Education

M.Sc./M.Tech./M.Pharm./M.E.

Tools

HPLC/UPLC

SEC-HPLC

RP-HPLC

IEX

HIC

CE-SDS

icIEF/cIEF

ELISA

UV/Vis

Job description

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.