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.
- Solid 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.

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