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.
- Solid 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.

📌 Executive / Sr Executive - Quality Control ( Biosimilars ) (Hyderabad)
🏢 MSN Group
📍 Hyderabad