About Client
Leading Biopharma company having microbial and Mammalian platform (Mabs)
Position Overview
We are seeking a highly motivated qualified to join our Drug Product Development team focused on monoclonal antibodies (mAbs) . The role involves end-to-end development of biologics drug products, including formulation, process development, characterization, and technology transfer to manufacturing sites. The candidate will collaborate cross-functionally with analytical, regulatory, quality, and manufacturing teams to ensure robust and compliant product development.
Key Responsibilities
- Formulation Development
- Design and optimize formulations for mAbs drug products (liquid and lyophilized).
- Conduct stability studies and evaluate excipient compatibility.
- Process Development
- Develop and scale-up drug product processes (filling, lyophilization, packaging).
- Support technology transfer to GMP manufacturing facilities.
- Characterization & Risk Assessment
- Perform product characterization (physicochemical, biophysical, and functional assays).




- Assess critical quality attributes (CQAs) and establish control strategies.
- Regulatory & Documentation
- Author technical reports, regulatory submissions (IND, BLA, NDA, IMPD).
- Ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines.
- Cross-functional Collaboration
- Partner with analytical, clinical, and manufacturing teams to align development strategies.
- Support troubleshooting during clinical and commercial manufacturing.
- Innovation & Continuous Improvement
- Evaluate new technologies for formulation and process optimization.
- Drive efficiency in development workflows and documentation practices.

Qualifications
- Education : Ph.D./M.Pharm in Pharmaceutics, Biotechnology, Biochemistry, Chemical Engineering, or related field.
- Experience :
- 5–10 years (Ph.D.) or 8–12 years (M.S/ M.Pharm) in biologics drug product development.
- Hands-on expertise in mAbs formulation, lyophilizat

📌 AGM/ DGM (Navi Mumbai)
🏢 Talental Consultings
📍 Navi Mumbai