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
2. Support characterization of primary structure, higher-order structure, purity, charge variants, aggregates, fragments, and post-translational modifications.
3. Execute analytical experiments according to approved protocols and prepare accurate experimental records.
4. Perform method development, optimization, robustness studies, validation/verification, and analytical method transfer.
5. Support comparability studies between biosimilar candidates and reference/innovator products.
6. Analyze experimental data, interpret results, and prepare technical reports.
7. Support stability studies, forced degradation studies, and characterization studies.
8. Investigate OOS/OOT and analytical discrepancies and support root-cause investigations.
9. Coordinate with Process R&D;, Formulation R&D;, Quality Control, Quality Assurance, and Regulatory Affairs teams.
10.



Prepare and review analytical protocols, reports, specifications, SOPs, and other R&D; documents.
11. Support regulatory submissions and responses related to analytical development and characterization.
12. Ensure compliance with GLP/GMP, data-integrity requirements, SOPs, and applicable regulatory guidelines.
13. Technical Skills

14. Strong hands-on experience in analytical characterization of biosimilars/biologics.
15. Good understanding of protein chemistry and analytical techniques.
16. Experience in chromatographic and electrophoretic techniques.
17. Knowledge of ICH guidelines, QbD, method validation, analytical comparability, and stability studies.
18. Experience with data interpretation, troubleshooting, and technical documentation.
19. Exposure to advanced characterization techniques such as LC-MS/MS, peptide mapping, glycan analysis, intact mass, or bioassays will be an added advantage.
20. Qualification

21. M.Sc./M.Tech./M.Pharm./M.E. in Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline.
22. 2–7 years of relevant experience in Analytical R&D;, biologics, biosimilars, or protein characterization.
23. Preferred Candidate Profile

24. Candidates with hands-on experience in biosimilar analytical development/characterization.
25. Good experimental and troubleshooting skills.
26. Robust documentation and scientific-report-writing abilities.
27. Ability to independently execute analytical experiments and interpret data.
28. Good communication and cross-functional coordination skills.
29. Experience working in a regulated R&D;/GMP environment is preferred.

📌 Executive / Sr executive - Analytical R&D (Biosimilars) (Hyderabad)
🏢 MSN Group
📍 Hyderabad