Injectable Product Development Scientist / Manager

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

Position: Injectable Product Development Scientist / Manager

Job Summary

The Injectable Product Development professional is responsible for the development, optimization, and scale up of sterile injectable drug products. This role involves formulation development, process development, scale-up, technology transfer, and regulatory support in compliance with global regulatory standards (FDA, EMA, ICH).

Key Responsibilities

Product & Formulation Development

• Design and develop sterile injectable formulations (solutions, suspensions, lyophilized products).
• Peptide product development with device exposure
• Select and justify excipients based on stability, compatibility, and patient safety.
• Define Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQAs).
• Perform compatibility studies, forced degradation, and stress testing.

Process Development & Manufacturing

• Develop and optimize compounding, sterile filtration, aseptic filling, and lyophilization processes.
• Support scale-up, process validation, and commercial manufacturing.
• Review batch manufacturing records (BMRs) and process flow diagrams.
• Support technology transfer to pilot plant and commercial sites.

Analytical & Stability Support

• Collaborate with analytical teams on method development and validation.
• Design and interpret stability studies (accelerated, long-term, in-use).

Regulatory & Documentation

• Prepare CMC sections for IND, NDA, ANDA, or BLA submissions.
• Support responses to regulatory queries and agency inspections.
• Ensure compliance with cGMP, ICH Q8/Q9/Q10, and pharmacopeial requirements.

Cross-Functional Collaboration

• Work closely with Quality, Manufacturing, Regulatory Affairs, Clinical, and Supply Chain teams.
• Support risk assessments and control strategies.
• Contribute to continuous improvement and cost optimization initiatives.

Required Qualifications

Education

• M.Pharma in Pharmaceutics / Pharmaceutical Sciences.

Experience

• 10+ years of experience in sterile injectable product development.
• Hands-on experience with aseptic processing and/or lyophilization.
• Experience with regulatory filings and CMC documentation preferred.