FierceBiotech and FiercePharma Jobs
Methods Development Chemist - MR-Raleigh
Sep 12
Location: Raleigh, NCCategories: Research
Position Description
My client is an early stage molecular imaging company that is developing Imaging Diagnostics for selected CNS disease. The firm is backed by blue chip venture capital investors and top caliber scientists.
Position:GMP Analytical Methods Development Chemist
DESCRIPTION:
Designs and initiates development and validation of appropriate analytical methods and improvement of existing ones to support all stages of drug development from drug substance characterization through clinical and commercial formulations and process development and registration. Performs and supervises as appropriate activities to demonstrate method suitability for application to drug substance and product scale up and commercialization.
Critically evaluates and interprets experimental data for conclusions and resolution of problems. Establishes and coordinates activities at contract chemical, formulation, and analytical laboratories, as required. Prepares reviews and approves analytical data, technical reports and analytical methods in support of and for inclusion in the regulatory submissions.
Establishes collaborative working relationships with product and process development, and other groups to ensure consistency of analytical methodologies throughout the drug development process.. Sets priorities to meet changing needs from multiple projects.
Position Requirements
• BS in Chemistry or related discipline with at least 3 years of experience in development and application of analytical methods to support development of parenteral dosage forms from pre clinical stage through registration in USA and Europe.
• Extensive knowledge of state of the art separation sciences theory and applications and current state of technology
• In depth knowledge of principles and applications of HPLC and detection systems, LC/MS, UV/VIS and other methodologies to determine potency, purity, impurities of drug substances and drug products and characterization of impurities and degradation products.
• Proven ability to apply advanced chemical science principles, theories, concepts to a broad range of research problems and develop innovative solutions for analytical problems related to drug substances and drug products. Demonstrated ability to critically evaluate and interpret all scientific data including stability data and provide the significance.
• Knowledge of US and international CMC regulatory requirements and cGMP and their utilization to support global product registration.
• Excellent written and oral communications, project management and team leadership skills. Demonstrated ability to work on multiple projects and meet timelines
Michael A. Terretti
Managing Director
Global Life Sciences
MRI-Raleigh
919-781-0400×112 office
mterretti@mriraleigh.com
