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Director/Sr Director, Analytical Development

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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 motivated individual to lead the analytical development for our small molecule pipeline.

Essential Functions of the Job (Key responsibilities)

Provide technical expertise on analytical methods for drug substance and drug product.

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 substances and products.

Identify external contract labs, monitors external contracts and write/review change controls.

Work with QA, Process Chemist, Product Development and Analytical Scientists to implement and transfer appropriate analytical methods with CMO's

Write and review technical documentation for contributing to regulatory filings. Experience with regulatory aspects analytical sections of NDA's, MAA's is required

Works with European, Japanese and global technical operations teams

Manage junior scientists; provide scientific guidance as needed.

Qualifications (Minimal acceptable level of education, work experience, and competency)

Must Ph.D. in pharmaceutical sciences or other relevant field.

Minimum of 15 years pharmaceutical R&D experience.

Knowledge of GMP requirements, FDA/ICH guidance and regulatory requirements relative to drug substance characterization and drug product release.

Experience in managing and leading teams.

Strong familiarity in late stage small molecules analytical development including validation

Excellent written and oral communication, including experience delivering professional internal and external presentations.

Strong analytical skills with a demonstrated ability to think strategically.

Strong problem-solving skills with a track record of identifying and implementing novel solutions.

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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You can learn more about Incyte's data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

 

We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

        

 

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Job Posting: 855456

Posted On: Oct 09, 2021

Updated On: Nov 08, 2021