About Client

Leading Biopharma company having microbial and Mammalian platform (Mabs)

Position Overview

We are seeking a highly motivated professional 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./ in Pharmaceutics Biotechnology Biochemistry Chemical Engineering or related field.
- Experience :
- 5–10 years (Ph.D.) or 8–12 years (M.S/ ) in biologics drug product development.
- Hands-on expertise in mAbs formulation lyophilization and aseptic processing.
- Experience with regulatory submissions and GMP environments.

- Technical Skills :

- Strong knowledge of protein chemistry stability and degradation pathways.
- Familiarity with analytical techniques (DSC DLS SEC LC-MS etc.).
- Understanding of container-closure systems and packaging development.

- Soft Skills :

- Excellent communication and documentation skills.
- Robust problem-solving and cross-functional collaboration abilities.
- Ability to manage multiple projects and timelines.

Required Skills:

Formulation Development Biologics Biosimilar mAbs DP drug product development

📌 AGM DGM Drug Product Development (Biologics) (Navi Mumbai)
🏢 Talental Consultings
📍 Navi Mumbai