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 Investigational Material Supply Chain is looking for a Senior Manager, Clinical Supply Operations. This position manages clinical supply chain of compounds in the clinical stage of development.
Essential Functions of the Job (Key responsibilities)
Manage all aspects of clinical study requirements and Clinical Packaging activities.
Work with clinical operations, project management and tech ops to establish and meet timelines for clinical supplies available for clinical trials.
Recommend new procedures and processes to manage the growth of clinical supplies and number of clinical trials being conducted by Incyte.
Identify external packaging sites, monitors external clinical packaging, and reviews master and executed batch records.
Coordinate GMP auditing activities at CMOs; provides management with accurate time frames for resolution of delays in obtaining supplies for clinical projects; recommends insight and ideas into procedural improvements as needed and assist in the implementation of the improvements.
Work with tech ops and clinical operations in managing inventory of clinical supplies before and during clinical studies.
Develop and manages strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS or higher and minimum 5 years of experience in managing clinical packaging, clinical inventory and distribution.
Knowledge of US and Global clinical labeling, Ex-US depot and Qualified Person requirements for clinical supplies.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
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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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.