We are seeking an Analytical Development Scientist to develop and validate HPLC analytical methods in a GMP environment, and to support product development activities for oral solid dose tablets.
• Develop analytical methods for APIs and drug products, typically based on RP-HPLC with UV detection
• Qualify and validate analytical methods
• Perform quantitative and qualitative analyses on development and QC samples
• Prepare and qualify secondary analytical standards
• Develop and follow Standard Operating Procedures (SOPs), monographs and methods
• Use various analytical equipment (HPLC, Dissolution Apparatus, Karl Fisher)
• Document methods and results into laboratory notebooks and logbooks
• Review and approve raw data generated by fellow analysts
• Bachelors or Masters in Chemistry or related field
• Minimum 5 years’ experience in a pharmaceutical (cGMP) laboratory
• Experience using fundamental analytical instrumentation and techniques (HPLC, Dissolution, Karl Fisher)
• Experience with method development and validation
• Ability to write validation protocols and reports
• Computer Knowledge and use of Microsoft Excel and Word
• Legible and thorough documentation skills
Starting salary will be commensurate with experience and will be part of a total compensation package that includes excellent benefits (medical, dental and 401k).
Local candidates preferred. No relocation assistance is available for this opportunity.
We are not accepting phone calls or emails from recruiters for this position.