Executive / Sr Executive - Quality Control ( Biosimilars )

Role & responsibilities

Quality Control Biosimilars | Executive / Sr. Executive

Company: MSN Laboratories
Location: Pashamylaram, Hyderabad, Telangana
Department: Quality Control – Biosimilars
Experience: 2–7 Years
Designation: Executive / Senior Executive

Job Responsibilities

• Perform quality control testing of biosimilar/biological products, intermediates, raw materials, and finished products.

• Execute analytical testing as per approved specifications, STPs, SOPs, and pharmacopoeial requirements.

• Perform testing using techniques such as:

• HPLC/UPLC

• SEC-HPLC

• RP-HPLC

• Ion Exchange Chromatography (IEX)

• CE-SDS / cIEF

• ELISA

• UV/Vis spectroscopy

• Protein concentration, purity, and related assays

• Perform physicochemical and biological testing of proteins/biologics as applicable.

• Handle stability sample testing and support stability-study activities.

• Review analytical data, calculations, chromatograms, system suitability, and test results.

• Ensure proper documentation of analytical results in worksheets, logbooks, LIMS, and other applicable systems.

• Investigate and support OOS, OOT, deviations, atypical results, and laboratory incidents.

• Perform instrument calibration, qualification checks, maintenance, and troubleshooting as required.

• Ensure proper handling, storage, labeling, and traceability of samples and reagents.

• Prepare and review SOPs, specifications, analytical methods, protocols, reports, and other QC documents.

• Support analytical method transfer, verification, validation, and qualification activities.

• Coordinate with Analytical R&D, Process R&D, QA, Production, and other cross-functional teams.

• Maintain laboratory compliance with GMP, GLP, data-integrity requirements, and applicable regulatory guidelines.

• Participate in internal audits, regulatory inspections, investigations, CAPA, and continuous-improvement activities.

Technical Skills

• Hands-on experience in QC testing of biologics/biosimilars.
• Strong knowledge of protein/biologics analytical characterization.
• Experience with chromatographic, electrophoretic, immunological, and spectroscopic techniques.
• Good understanding of GMP, GLP, data integrity, OOS/OOT investigations, deviations, and CAPA.
• Knowledge of ICH guidelines and pharmacopoeial requirements.
• Experience with LIMS and laboratory documentation systems is preferred.
• Exposure to advanced techniques such as LC-MS, peptide mapping, glycan analysis, bioassays, or cell-based assays is an advantage.

Qualification

• M.Sc./M.Tech./M.Pharm./M.E. in Biotechnology, Biochemistry, Chemistry, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 2–7 years of relevant experience in Quality Control/Analytical QC, preferably in biosimilars, biologics, or recombinant protein products.

Preferred Candidate Profile

• Experience in a GMP-regulated biologics/biosimilars QC laboratory.
• Strong analytical and troubleshooting skills.
• Good understanding of laboratory investigations and documentation.
• Ability to independently execute testing and review analytical data.
• Good communication and cross-functional coordination skills.
• Candidates with experience handling biosimilar characterization and release/stability testing will be preferred.