at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Global Pharmaceutical Development group is looking for a Director, Analytical Development. This position will be responsible for oversight of all Analytical Development activities needed to ensure successful clinical and commercial company goals are met in accordance with scientific and regulatory requirements.
Essential Functions of the Job (Key responsibilities)
Brings experience and innovative approaches to clinical and commercial regulatory filings as well as the ability to rapidly respond to regulatory questions.
Establishes external contacts with CROs. Monitors, reviews and guides that analytical activities at external laboratories to ensure high quality and timely analytical deliverables and provides guidance for investigations/deviations.
Acts as a technical expert for analytical techniques for the analysis of drug substance and drug product through collaboration with process chemistry and product development to ensure appropriate analytical methods development and characterization of drug substance/product.
Develops phase appropriate specifications to ensure drug substance/product quality and regulatory acceptance.
Critically assesses stability and supportive data and establishes appropriate retest periods/shelf life to ensure the quality of drug substance/product is maintained.
Is proficient in GMP, Industry and Regulatory requirements.
Authors analytical sections of regulatory filings as well as reviews CMC sections to ensure consistent regulatory strategy.
Authors/reviews SOPs that ensure phase appropriate quality and compliance within Global Technical Operations.
Provides mentoring/leadership to facilitate development of junior team members.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Must have an MS at a minimum (Ph.D. preferred) in Analytical or Organic Chemistry or other relevant field.
Must have 10 years minimum of related analytical development experience in a drug development setting.
Must have thorough knowledge of GMP, Industry and Regulatory requirements as well as significant experience with authoring/reviewing commercialization filings.
Ability to manage and lead teams.
Thorough knowledge of chemistry and expertise with analytical methodologies for the testing of small molecules.
Hands-on experience with analytical methods for the testing of small molecules such as HPLC/UPLC, LC-MS, dissolution, Karl Fischer titration, and GC.
Superior communication skills for interactions with technical personnel both internally and externally, cross-cultural team skills
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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