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Principal Investigator/Associate Director, Biologi

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 BioPharmaceutical Development Group is looking for a Principal Investigator / Associate Director, Biologics Analytical Development. This position is responsible for analytical method development to support product release and characterization, and CMO analytical activity management for the biologics pipelines used for clinical studies and commercial launch. This is a hand-on position will be actively engaged with collaborators/partners and CMOs, and interface with our quality group to support product and reference material release, and analytical method transfer or qualification/validation. This position requires solid scientific knowledge of a variety of analytical methods, broad and relevant industrial experience in biologics development from early stage, late stage to commercial launch, being familiar with ICH guidance and management skill.
Essential Functions of the Job (Key responsibilities)
Contributes to project strategy in pursuit of set goals within a single discipline. Proven technical and hand-on expertise with execution and troubleshooting of analytical separation techniques such as HPLC, CE, and cIEF assays. Drive the development of analytical methods. This position leads method development, data analysis, prepare technical reports and propose comprehensive solutions and improvements. This position develops technical solutions to problems independently, proactively exchanges technical information with team members with research, process science and with cross functional groups for troubleshooting and ongoing supports.
This position will supervise and manage the analytical separations team in the development lab.
Review analytical data package.
Perform stability trending analysis.
Participate in planning and managing analytical method qualification/validation and transfer to QC lab.
Write technical reports including, but not limited to stability summary report, comparability protocol and report, and method transfer plan.
Write SOPs related to analytical development for biologics.
Work closely with our quality group to ensure complying with our internal quality policy.
Work closely with collaborators and CMOs to ensure the analytical activities being conducted properly and timely manner.
Support regulatory filling.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Doctoral degree with more than 10 years relevant experience or Masters' degree with more than 14 years relevant experience.
Knowledge in protein chemistry and large molecules is must.
Extensive experience with analytical instrumentation.
Developing and implementing separations methods including HPLC, cIEF, CE etc.
Developing analytical methods transfer strategy and protocols to QC laboratories
Statistical analysis skill.
Partner extensively within Biologics and Pharmaceutical Development, and with other Incyte functions, including Research, Regulatory CMC, QA, Tech Ops and Legal.
Manage external collaborations through scientific and strategic understanding, and attention to program success, to maximize integration and synergy between Incyte and partner.
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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Job Posting: 1051384

Posted On: Oct 02, 2022

Updated On: Nov 01, 2022