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 positive 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.
- Solid 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.

📌 Manager - Research and Development (Biosimilar) (Halol)
🏢 BDR Pharmaceuticals
📍 Halol