Executive / Sr Executive - R&D (Biosimilars)

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.
• Good 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.