Formulation Scientist (Sterile Injectables)

Position: Formulation Scientist - Sterile Injectables
Employment Type: Full-Time | On-Site
Industry: Pharmaceutical Manufacturing & Development

About the Role

This rapidly expanding Pharma Organization is seeking a highly skilled and motivated Formulation Scientist with expertise in sterile injectable drug products to join their dynamic R&D team. This role is critical in supporting the development of parenteral formulations to commercial scale-up and manufacturing for various projects. The successful candidate will play a pivotal role in designing, developing, and optimizing injectable formulations in a cGMP-compliant environment.

Key Responsibilities

• Design and develop sterile injectable formulations (solutions, suspensions, emulsions, lyophilized products).
• Conduct pre-formulation studies, compatibility assessments, and stability testing.
• Lead scale-up and tech transfer activities to manufacturing.
• Collaborate with cross-functional teams including Analytical, Quality, Regulatory, and Manufacturing.
• Author technical reports, protocols, and regulatory documentation (IND, NDA, ANDA).
• Ensure compliance with FDA, USP, and ICH guidelines.

Qualifications

• Ph.D. OR M.S. OR B.S. in Pharmaceutics, Chemistry, or related field.
• 3-7 years of industry experience in sterile injectable formulation development.
• Strong understanding of aseptic processing, lyophilization, and container-closure systems
• Experience with parentals/lyophilized/liquids/vials/pre-filled syringes
• Experience with QbD principles and risk-based development approaches.
• Excellent problem-solving, documentation, and communication skills.