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, Pharmaceutical Development. This positionis responsible for manufacture and analytical support for Incyte's late stage and commercial products.
Essential Functions of the Job (Key responsibilities)
Provide technical expertise on the transfer of manufacture and analytical methods for late stage commercial drug products (small molecules). Solid dosage form and topical experience a plus.
Working knowledge of analytical techniques, such as HPLC, GC, MS, IR, thermal techniques, and dissolution.
Ability to develop specifications and revise methods for global drug products.
Identify external contract labs, monitors external contracts and reviews batch records/change controls.
Work with QA and Product Development/Analytical Scientists to implement and transfer appropriate manufacturing process for drug products as well as analytical methods
Write and reviews technical documentation for contributing to regulatory filings.
Works with European, Japanese and global technical operations teams
Qualifications (Minimal acceptable level of education, work experience, and competency)
Minimum of 15 years pharmaceutical experience.
Knowledge of GMP requirements, FDA/ICH guidance and global regulatory requirements relative to drug product manufacture and release.
Strong familiarity in late phase/commercial small molecules development
Excellent written and oral communication, including experience delivering professional internal and external presentations.
Strong analytical skills with a demonstrated ability to think strategically.
Solid negotiation skills in quotation and a persuasive project management style when working with CMO/CRO to achieve company's business and technical objectives.
Transparent and direct communication styles internally and externally.
Able to work in a fast-pace and constantly changing working environment.
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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