Role & responsibilities

Company: MSN Laboratories

Location: Pashamylaram, Hyderabad, Telangana

Department: R&D; Process Development / Biosimilars

Experience: 2–7 Years

Designation: Executive / Senior Executive

Job Responsibilities

- Execute process development activities for biosimilarproducts from laboratory scale through scale-up.
- Develop and optimize upstream/downstream processes for recombinant proteins and other biologics.
- Perform process development experiments involving cell culture, fermentation, harvest, clarification, chromatography, filtration, and purification.
- Support optimization of critical process parameters (CPPs) and identification of critical quality attributes (CQAs).
- Conduct DoE-based process optimization and evaluate experimental data.
- Support process characterization, scale-up, process validation, and technology-transfer activities.
- Execute laboratory and pilot-scale experiments and maintain accurate experimental records.
- Perform troubleshooting of process-related issues and recommend corrective actions.
- Coordinate with Analytical R&D;, Formulation, Quality, Manufacturing, and other cross-functional teams.
- Prepare development protocols, batch records, reports, SOPs, process descriptions, and technology-transfer documents.
- Support preparation of regulatory documentation related to process development and characterization.




- Ensure activities are performed in accordance with GMP, GLP, EHS, and applicable regulatory requirements.

Required Technical Skills

- Hands-on experience in biosimilar process development.
- Knowledge of upstream and/or downstream processing.
- Understanding of mammalian cell culture and recombinant protein production is preferred.
- Experience with chromatography techniques such as Protein A, IEX, HIC, SEC, affinity chromatography, etc.
- Knowledge of UF/DF, filtration, clarification, viral clearance/inactivation and related downstream operations.
- Familiarity with DoE, QbD, CPP/CQA, process characterization and scale-up.
- Good understanding of scientific data analysis and technical documentation.

Qualification

- M.Sc./M.Tech./M.Pharm./M.E. or equivalent qualification in Biotechnology, Biochemistry, Microbiology, Life Sciences, Pharmaceutical Sciences or related discipline.
- 2–7 years of relevant experience in biologics/biosimilar process R&D.;

Candidate Profile

- Strong experimental and problem-solving skills.
- Positive understanding of biologics manufacturing processes.
- Ability to independently plan and execute experiments.
- Good technical writing and documentation skills.
- Ability to work effectively with cross-functional teams.

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