Executive / Sr Executive - R&D (Biosimilars)

MSN Group; Hyderabad; Sur place; INR 900 000 - 1 200 000; Plein temps

Résumé du poste

MSN Laboratories in Hyderabad, Telangana, is seeking an Executive/Senior Executive for Biologics/Biosimilar process R&D. The role focuses on biosimilar process development from lab to scale-up, including upstream/downstream processing, and DoE-based optimization.

You will collaborate with Analytical R&D, Formulation, Quality, and Manufacturing teams, maintaining records and ensuring GMP/GLP compliance. Requires 2–7 years in biologics/process R&D and relevant MSc/ME/MTech/MPharm/M.E. degrees.

Qualifications

• MSc/ME/MTech/MPharm/M.E. in Biotechnology or life sciences or related field.
• 2–7 years of biologics/biosimilar process R&D experience.
• Experience with upstream/downstream processing and chromatographic techniques.

Responsabilités

• Execute process development activities for biosimilar products from lab to scale-up.
• Develop and optimize upstream/downstream processes for recombinant proteins and biologics.
• Perform DoE-based process optimization and analyze results.
• Coordinate with cross-functional teams (Analytical R&D, Formulation, Quality, Manufacturing).
• Prepare development protocols, batch records, reports, SOPs, and tech-transfer docs.
• Ensure GMP/GLP/EHS compliance and regulatory documentation.

Connaissances

Biosimilar process

Upstream/downstream processing

Cell culture

Protein A chromatography

IEX chromatography

HIC chromatography

SEC chromatography

DoE/QbD

Process characterization

Data analysis

Formation

MSc in Biotechnology

MTech in Biotech

MPharm

M.E. in Life Sciences

Outils

DoE software

QbD documentation

Description du poste

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.