Drug Product Development (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