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 recent 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, 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.
Strong problem-solving and cross-functional collaboration abilities.
Ability to manage multiple projects and timelines.

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Skillset Required: Formulation Development, Biologics, Biosimilar, mAbs, DP, drug product development

Required Skill Profession

Other General

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