Senior Scientist

Job Description

Company Name: PPD Development, L.P.

Position Title: Senior Scientist

Location: 8551 Research Way, Suite 90, Middleton, WI 53562

Summary of Duties: Independently performs method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision. Prepares study protocols, project status reports, final study reports, and other project related technical documents. Communicates data and technical issues to the client and responds to client needs and questions. Mentors, trains, and coordinates laboratory activities of other team members. Assists in troubleshooting instrument and analytical problems. Assists with quality systems and new equipment. Designs method validation or method transfer protocols and establishes project timelines. Reviews, interprets, and analyzes data for technical quality and compliance to protocols, methods, SOPs, client criteria, and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Qualifications: PhD in Chemistry, Pharmaceutical Science, Engineering (any field), Environmental Science, or a related scientific field, and six (6) months of experience as a Quality Control Chemist, Research Scientist, Research Assistant, Research Associate, Teaching Assistant, or a related scientific laboratory role. Employer will also accept a Bachelor's degree in Chemistry, Pharmaceutical Science, Engineering (any field), Environmental Science, or a related scientific field; and five (5) years of experience as a Quality Control Chemist, Research Scientist, Research Assistant, Research Associate, Teaching Assistant, or a related scientific laboratory role. Six (6) months of experience with: General chemistry and separation science; Microsoft Excel and Word; Technical operating systems; Technical writing such as Scientific Reports, Laboratory and Data Analysis Reports, or Documenting Experiments; Chromatography, including Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC) instrumentation; Flame ionization detection (FID) and Ultraviolent (UV) detection; Liquid-liquid and liquid-solid solvent extractions; and ICH guidelines, USP requirements, and FDA guidance. Experience with the required skills may be gained through graduate-level coursework.

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