Manager - Research and Development (Biosimilar)

Key Responsibilities

1. Biosimilar Development

• Lead and manage end-to-end R&D activities for development of biosimilar products, particularly monoclonal antibodies.
• Develop product and process development strategies based on the reference product's critical quality attributes (CQAs) and manufacturing characteristics.
• Plan and execute development activities including formulation development, process optimization, analytical characterization, and product comparability.

2. Monoclonal Antibody Expertise

• Strong understanding of the structure, function and characteristics of monoclonal antibody therapeutics.
• Knowledge of key mAb quality attributes, including:
• Primary and higher-order structure
• Molecular weight and purity
• Aggregation and fragmentation
• Charge variants
• Glycosylation profile
• Disulfide bonding

3. Analytical & Characterization Development

• Hands-on understanding of analytical methods used for biosimilar characterization and comparability.
• Experience/exposure in techniques such as:
• HPLC/UHPLC and related chromatographic techniques
• SEC, IEX, HIC and RP-HPLC
• LC-MS / mass spectrometry
• Peptide mapping
• Glycan/glycosylation analysis
• Capillary electrophoresis
• SDS-PAGE
• Spectroscopic techniques
• Bioassays and potency assays

4. Equipment & Infrastructure Knowledge

The candidate should have a good understanding of equipment and infrastructure required for development and characterization of biosimilars, including, as applicable:

• Bioreactors / cell culture systems
• Chromatography systems and KTA-type platforms
• UF/DF systems
• TFF systems
• Protein purification systems
• HPLC/UHPLC systems
• LC-MS/MS and mass spectrometers
• CE-SDS / capillary electrophoresis systems
• IEX, SEC and HIC platforms
• Bioreactor monitoring and process analytical systems
• ELISA, SPR/BLI and other binding-assay platforms
• Cell-based bioassay systems
• Stability chambers
• Appropriate laboratory-scale equipment for formulation and process development.

5. Regulatory & Documentation

• Mandatory experience/exposure in regulatory submissions for biosimilars/biologics.
• Work closely with Regulatory Affairs teams in preparation and review of regulatory documentation and responses.
• Provide technical inputs for dossiers, including CMC, analytical characterization, comparability and development sections.
• Support regulatory queries, deficiency responses and scientific justifications.
• Maintain development documentation in accordance with applicable GMP, GLP, data integrity and quality requirements.

EMA and other major regulatory authorities, is desirable.

Required Technical Competencies

• Strong knowledge of biosimilar development principles and comparability assessment.
• Strong expertise in monoclonal antibody development and characterization.
• Proven hands-on experience in biologics/biosimilar R&D.
• Understanding of upstream and/or downstream process development is highly desirable.
• Strong knowledge of analytical characterization of therapeutic proteins.
• Ability to design experiments and interpret complex analytical datasets.
• Understanding of QbD, risk assessment, CQA, CPP and process/product characterization concepts.
• Knowledge of stability studies and degradation pathways of monoclonal antibodies.
• Experience with technical report writing, scientific documentation and regulatory responses.
• Strong problem-solving and scientific troubleshooting skills.

Mandatory Experience

The candidate must demonstrate a previous hands-on track record of successful development of biosimilar products.

Preference will be given to candidates who have:

• Worked on the successful development of multiple biosimilar products.
• Direct experience with monoclonal antibody biosimilars.
• Participated in development programs progressing from laboratory development through scale-up/clinical or commercial stages.
• Experience supporting or contributing to regulatory submissions for biosimilars/biologics.