Senior R&D Scientist

Responsibilities

• Applies the principles, theories, and techniques of Good Laboratory Practices (GLP) to produce and report appropriate pharmaceutical laboratory results
• Maintains an optimized schedule of method development activities
• Performs method/sample validation including: Method development, generating protocol specified data, analysis of data according to validation parameters, statistical analysis of data, stability study trending, and validation report writing
• Ensures sample testing runs accurately and comprehensively, records data in laboratory notebooks, calculates results, and maintains work area cleanliness and organization
• Participates in and records quality investigations and corrective actions, where appropriate
• Writes formal validation plans, timelines, and reports and provides oversight into the creation and execution of validation plans and reports of all R&D projects
• Trains R&D staff in principles of methods and applications within the services according to CED Analytical Laboratory quality system procedures
• Investigates, installs, evaluates, and purchases laboratory equipment, instrumentation, computer software/hardware, and other specialty items
• Collaborates with various groups for study-level publication planning including manuscript writing and submissions
• Generates documents to support regulatory submissions and/or responds to questions from regulatory authorities about existing submissions
• Participates in quality investigations and corrective actions, where appropriate
• Reviews literature and competitive information for R&D planning and analysis of results
• Assists in the investigation, installation, evaluation, and purchase of laboratory equipment, instrumentation, computer software/hardware, and other specialty items
• Participates in and records quality investigations and corrective actions, where appropriate
• Reviews literature and competitive information for R&D planning and analysis of results
• Collaborates to achieve publications for pharmaceutical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
• Generates documents to support regulatory submissions and/or responds to questions from regulatory authorities about existing submissions

Qualifications

• MS in chemistry or a science related field, or equivalent years of method validation and development experience
• Eight (8) years of laboratory experience performing analytical testing
• UPLC/HPLC/GC expertise, method development and/or method validation experience required
• Working knowledge of cGMP/GLP, ICH, USP/NF, FDA regulations
• Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel)
• Excellent communication skills; English (oral & written)
• Strong work ethic and reliable
• Excellent time management and organizational skills
• Able to work under pressure and successfully function in a fast-paced environment