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 current 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