Sr. Research Investigator, Biologics Analytical Development

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 Senior Research Investigator, Biologics Analytical Development 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 hands-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, and being familiar with ICH guidance.

Essential Functions of the Job (Key responsibilities)

• Support regulatory fillings if needed.
• Work closely with collaborators and CMOs to ensure the analytical activities being conducted properly and timely manner.
• Work closely with our quality group to ensure complying with our internal quality policy.
• Write SOPs related to analytical development for biologics.
• Write technical reports including, but not limited to stability summary report, comparability protocol and report, and method transfer plan.
• Participate in planning and managing analytical method transfer/qualification/validation.
• Perform stability trending analysis.
• Review analytical data package.
• Contributes to project strategy in pursuit of set goals within a single discipline. Demonstrated expertise in execution and troubleshooting of manual methods and immunoassay technologies such as ELISA, ECL (MSD), BIACORE assays. Drive the development of analytical methods. This position leads method development, data analysis, prepares technical reports, and proposes comprehensive solutions and improvements. This position develops technical solutions to problems independently and proactively exchanges technical information with team members, research, process science, and cross-functional groups for troubleshooting and ongoing support.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Proficiency in statistical analysis, with an emphasis on diverse methodologies and inclusive data interpretation.
• Knowledge in protein chemistry and large molecules is required. Experience with analytical instrumentation is preferred.
• Demonstrated experience with Octet and/or Biacore or equivalent skills or knowledge.
• Demonstrated experience with ELISA techniques or equivalent skills or knowledge.
• Advanced degree (e.g., Doctoral or Master's) with relevant experience, or equivalent combination of education and experience.
• Strong written and verbal communication and organization skills are required.
• Manage external collaborations through scientific and strategic understanding, and attention to program success, to maximize integration and synergy between Incyte and partners, ensuring inclusivity and respect for diverse perspectives.
• Partner extensively within Biologics and Pharmaceutical Development, and with other Incyte functions, including Research, Regulatory CMC, QA, Tech Ops and Legal.

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.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.