Formulation Development (Biologics) ExecutiveSr ExecutiveManagerSr Manager

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

Why Join Us

• Opportunity to contribute to life-saving biologics development.
• Work in a collaborative innovation-driven environment.
• Competitive compensation benefits and career growth opportunities.

Required Skills:

Formulation Development Biologics Biosimilar mAbs DP drug product development