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.
Job Summary (Primary function)
Reporting to Senior Director, Analytical Sciences within Biopharmaceutical Development, the Analytical Project Lead is responsible for analytical support early to late stage development internally/externally and manufacturing performed. The incumbent is actively engaged with development teams/collaborators/partners, CMOs, quality assurance and regulatory CMC groups to support product specifications, stability, investigations, analytical method transfer, qualification/validation, and annual product review. The incumbent has solid scientific knowledge of a variety of analytical methods, broad and relevant industrial experience, familiarity with ICH and other international guidance, as well as global regulatory requirements to support global filing strategy.
Essential Functions of the Job (Key responsibilities)
Lead implementation of changes to specifications of materials, parts, and products based on regulatory feedback or continued product knowledge.
Oversee external manufacturing quality control, meeting product specifications and expectations.
Participate in audits at CMO and QC lab as required to support quality assurance. Report out specified key performance indicators and communications; specific to quality and associated processes. Understand and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
Develop and maintain analytical policies and procedures, change controls, deviations, CAPAs, validation protocols, etc. Approve of analytical test methods that progress from development to the commercial arena.
Responsible for ensuring successful internal/external tech transfer of qualified/validated methods from one partner/CMO to another as projects may require.
Identify opportunities for continuous improvement of analytical methods or techniques and justify implementation plans to development teams.
Support and document OOS and OOT investigations until corrective plans are completed. Incorporate risk management principles into the management and decision making process, while promoting quality awareness and continuous improvement
Work with CMOs to complete lot disposition as required. Identify and resolve testing issues with service providers and CMOs. Providing microbiological expertise and support for product investigations, improvements, etc. to ensure continued compliance with regulations
Effectively interacting with internal/external development departments, quality groups, manufacturing in engineering materials, bulk and finish products.
Support CMO and QC lab in Agency Inspectors' routine inspections.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS degree in Chemistry with 10 years of relevant biopharmaceutical experience or MS degree in Chemistry with 7 years of relevant biopharmaceutical experience.
Knowledge in protein chemistry and large molecules is a must.
Experience in a variety of analytical techniques and their application within a Drug Development setting.
Excellent interpersonal skills as well as 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.
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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1801 Augustine Cutoff
Wilmington, Delaware 19803