Job Description:   Drug Product Development Support (Temporary)

Summary:

Provide scientific and technical support on drug product development

Responsibilities:

  • Assist with oversight of formulation/process development, scale-up and manufacturing at contract manufacturing sites
  • Assist in developing and implementation of formulation strategy to support clinical development and commercialization
  • Evaluate and characterize physical and chemical properties of drug products for toxicology, PK and clinical studies
  • Write technical reports documenting formulation/process development
  • Review and approve production documents, including protocols, development reports and batch documentation
  • Analyze and organize data using scientific software. Make recommendations based on the statistical analysis of CMC data
  • Other duties may be assigned as necessary

Requirements:

  • A minimum of 5 years relevant experience in formulation development and scale-up of oral solid dosage forms
  • Familiar with GMP requirements and regulation guidance applicable to small molecule drug products
  • Knowledge of statistical analysis and interpretation
  • Good written and verbal communication skills and interpersonal skills
  • Must be organized, understand the science and current industry practices
  • Understand in-process data techniques, analytical methods and specifications
  • Demonstrated ability to work on multiple projects and meet timelines
  • Good documentation and record keeping skills and attention to detail

Education:

BS or MS degree in Engineering, Pharmaceutical Sciences or a related discipline