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 motivated individual to lead the product development of Incyte's small molecule pipeline.
Essential Functions of the Job (Key responsibilities)
Provide technical expertise on formulating drug products (small molecules). Experience of extended release, pediatric dosage forms a plus.
Working knowledge of solid dosage form equipment and processes
Ability to develop new and innovative formulations, and improve existing ones.
Identify external contract labs, monitors external contracts and reviews batch records.
Work with external contract labs, QA and Process Chemist/Analytical Scientists to implement and execute Formulation strategy, and transferring appropriate manufacturing process for drug products.
Manage junior scientists; provide scientific guidance as needed.
Make recommendations on formulation development and manufacture process.
Write and reviews technical documentation for contributing to regulatory filings.
Works with European, Japanese and global technical operations teams
Assist with creating SOPs relative to formulation and manufacture process.
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 of the collection of analytical techniques that support the formulation, fill/finish process development work.
Excellent written and oral communication, including experience delivering professional internal and external presentations.
Strong analytical skills with a demonstrated ability to think strategically.
Knowledge of physical properties, pharmacology, clinical trial supply.
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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