Research Investigator, Biologics Analytical Develo

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 Research Investigator, Biologics Analytical Development. Reporting to Analytical lead of large molecules, this position will be responsible for analytical data review, stability tending analysis, analytical method selection to support product release and characterization, and CMO analytical activity management for the biologics pipelines used for clinical studies and commercial launch. This 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 validation. This role 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, and being familiar with ICH guidance. Strong interpersonal and communication skills are required.
Key responsibilities
Review analytical data package generated internally and from CMO testing labs
Perform stability trending analysis
Select analytical release, stability and characterization method panels as development stage appropriate
Participate in planning, managing analytical method transfer and qualification/validation
Write technical reports including, but not limited to stability summary report, comparability protocol and report, and method transfer plan/report
Write SOPs related to analytical development for biologics
Work closely with internal development teams and quality group to ensure complying with our internal quality policy
Work closely with internal development teams, collaborators and CMOs to ensure the analytical activities being conducted properly and timely manner
Support regulatory fillings
Qualifications (Minimal acceptable level of education, work experience, and competency)
Ph.D. with 5 years of experience in analytical development for biologics. Master's degree with 7- 10 years of relevant industrial experience.
Hands on experience on analytical method development, qualification, method transfer and validation
In-depth knowledge of a variety of release and characterization methods is a must.
Experience of interfacing with QA and QC groups
Experience in management of out-sourced manufacturing/development activities.
Familiar with ICH guidelines associated with life cycle management
Strong written and verbal communication and organization skills are required.
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: 895351

Posted On: Jan 11, 2022

Updated On: Feb 10, 2022