Manager, Product Development - United States
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Intercept Pharmaceuticals, Inc. is in search of a motivated individual to join our Product Development department to manage analytical activities from early clinical development to commercial phase for small molecules. This individual will work in virtual environment and will be responsible for leading and directing contract laboratories.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• Manage and provide technical guidance to contract laboratories for development and validation of analytical methods for API, intermediates and drug product, applying phase-appropriate approach
• Lead method transfer activities between the vendors and manage related technical activities
• Review of release data for API, intermediates, and drug product
• Collaborate closely with internal QA and Regulatory groups in setting phase appropriate specifications
• Perform detailed QA/QC review of test method validation/transfer protocols and reports and work closely with QA department to resolve issues
• Ensure consistent implementation of laboratory systems (e.g. reference standards, calibrations, etc.)
• Lead investigation activities for failed or non-conforming materials and implement corrective actions
• Review and/or approve vendor change controls for test methods, specifications, etc.
• Ensure compliance of analytical methods and validation procedures with ICH guidelines, FDA guidance, and global compendia, as applicable
• Represent CMC in interdisciplinary and technical project teams
• Assist with vendor selection, contract negotiations and budgeting
• Perform other duties as assigned
• Bachelor’s degree in a scientific field and 6 years’ experience or MS and 4 years of experience in pharmaceutical or related industry
• Hands on experience in a cGMP commercial production laboratory preferably with instrumentation such as HPLC, ( UV, ELSD, CAD) GC, MS, NMR, TLC, TGA, Karl-Fischer, FTIR, etc.
• Must have working knowledge of cGMP practices, ICH guidelines, and other regulatory documents
• Experience with designing method validation protocols
• Exceptional attention to detail
• Demonstrated ability to work in virtual environment within strict time constraints
• Ability to work independently as well as in a team environment on a variety of projects simultaneously
• Proven success in management and oversight of external contract testing laboratories
• Experience and fundamental knowledge of analytical validation principles
• Strong statistical background (desired)
• Excellent oral and written communication skills