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Formulation Scientist

SUMMARY The incumbent for this position will lead, execute, and support formulation and process development of in-house products and CDMO projects, technology transfer to Manufacturing locations, and execute batches for clinical supplies and Regulatory submissions.

RESPONSIBILITIES

 

  • Follow QbD methodology and sound scientific principles to develop robust scalable products – 50%

 

  • Develop protocols, generate data, and prepare product development reports to support development, Regulatory submissions, or validation in a compliant manner -10%

 

  • Secondary SME for regulatory and customer audits and technical meetings on clinical trials, formulation/process development and technology transfer to Manufacturing – 10%

 

  • Primary product development person for Piramal projects and technical contact for client communication – 10%

 

  • Collaborate with Analytical R&D and other cross-functional teams for timely completion and accurate interpretation of scientific data – 20%

QUALIFICATIONS

 

  • Bachelor’s Degree in Pharmaceutics, Pharmacy, Chemistry or Chemical Engineering required; Master’s preferred

 

  • 5+ years’ experience in formulations development or processing pharmaceutical products required. Liquids, semi-solids, and oral solid dosage forms experience highly preferred

 

  • Experience in development, DOE, QbD and SUPAC principles required

 

  • Thorough understanding of pre-formulation and early phase development to support NCE formulation development from Discovery through Phase 1 and Phase 2 clinical supplies essential

 

  • Knowledge of investigational techniques such as RCA and risk assessment preferred