Job Description

Department Details
Role Summary
The Ideal candidate would have:

• Drug product development experience preferably in the Biologics space.
• Candidate is expected to have hands on experience (not limited to) on analytical techniques like, HPLC, UPLC, Lyo, Karl Fischer, Solo VPE, MFI etc.
• Stability study: designing, protocol drafting, data evaluation and reporting
• Process related documents like FMEA, risk assessments, process characterization. specifications, TTD, etc.
• Basic idea of various regulatory filing and their requirements
• Understanding on filter validation
• Good communication skill (writing and verbal)
• Attitude to collaborate

Required Qualifications:
Education & Experience:

• BS/MS/MTech degree in Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemical Engineering, or related field.
• experience in drug product development for biologics (e.g., monoclonal antibodies, vaccines, gene therapies).
• Strong knowledge of formulation science, particularly in biologic drug products (injectable solutions, lyophilized products, etc.).
• Experience in GMP (Good Manufacturing Practices) and regulatory compliance for biologics.
• Hands-on experience with bioreactor operations, protein purification, and bioprocessing techniques is highly desirable

Key Responsibilities
The Ideal candidate would have:

• Drug product development experience preferably in the Biologics space.
• Candidate is expected to have hands on experience (not limited to) on analytical techniques like, HPLC, UPLC, Lyo, Karl Fischer, Solo VPE, MFI etc.
• Stability study: designing, protocol drafting, data evaluation and reporting
• Process related documents like FMEA, risk assessments, process characterization. specifications, TTD, etc.
• Basic idea of various regulatory filing and their requirements
• Understanding on filter validation
• Good communication skill (writing and verbal)
• Attitude to collaborate

Required Qualifications:
Education & Experience:

• BS/MS/MTech degree in Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemical Engineering, or related field.
• experience in drug product development for biologics (e.g., monoclonal antibodies, vaccines, gene therapies).
• Strong knowledge of formulation science, particularly in biologic drug products (injectable solutions, lyophilized products, etc.).
• Experience in GMP (Good Manufacturing Practices) and regulatory compliance for biologics.
• Hands-on experience with bioreactor operations, protein purification, and bioprocessing techniques is highly desirable

Educational Qualifications
Required Education Qualification: M.Tech
Required Experience: 0 - 1 years '