Formulations Scientist

1/21/22

Sellersville, PA

1564

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 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
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