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)
The Associate Director, Biologics Analytical Development possesses broad knowledge and experience in analytical method development, protein structure analysis and characterization, specializing in antibody molecules with hands-on experience in the method development for biophysical and biochemical analysis of proteins, including but not limited to chromatographic methods, mass spectrometry, cIEF, ELISA, cSDS, etc.
Essential Functions of the Job (Key responsibilities)
Develop strategy to deliver an acceptable and product specific analytical package to support clinical studies from Phase 1 to BLA/NDA.
Profound scientific knowledge in structure-function analysis of antibody molecules.
Review and approve regulatory filing documents and responses from global regulatory agencies.
Oversee standard release assay panel development for drug substance and drug product.
Lead clinical phase-specific product characterization and comparability studies required for regulatory filing.
Develop fit-to-phase plans for method validation and transfer.
Write, review and approve analytical and stability sections for regulatory filing.
Qualifications (Minimal acceptable level of education, work experience, and competency)
PhD in biochemistry, biochemical engineering, chemistry or equivalent.
10+ years of experience in biotechnology or pharmaceutical industry with a track record of leadership and success.
Proficient in study design, protocol and technical report writing and review.
Excellent oral and written communication skills.
Good inter-personal skill to work with regulatory, QA, QC, CRO and CMO.
Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
Knowledge in antibody drug development.
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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