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Sr. Director, Process Sciences

Company: The American College of Radiation Oncology
Location: Wilmington
Posted on: February 25, 2021

Job Description:

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 Sr Director of Process Science. This role will provide leadership to Incyte Biologics specifically in the area of cell culture, purification, and cell line development of monoclonal and bi-specific antibodies. This position will hold a breath of responsibility starting with interfacing with Discovery to progress molecules from pre-clinical to clinical stage, subsequently preparing the process and technology for commercial manufacture, and ensuring a successful BLA package. As a key opinion leader, this position will drive process validation and play an instrumental role in establishing best practices for technology transfer to both internal and external DS manufacturing sites.

Essential Functions of the Job (Key responsibilities)

  • Rapidly deliver cell line and manufacturing process using existing platform suitable to enable FIH clinical trials
  • Ensure global regulatory filings and responses to health authorities are clearly written and appropriate for the current trends.
  • Oversee cell line and technology development using internal and external labs as required.
  • Grow, develop, and lead the Biologics process sciences core functional capabilities which includes resource planning, recruiting top talent, and setting up internal labs.
  • Identify new technologies to evaluate and oversee the development of a next generation platform.
  • Lead/play a key role in technology transfer governance and approaches both internally and externally.
  • Responsible for successful and timely completion of FMEA, process characterization, process validation strategy, and protocol development.
  • As life cycle management may require, optimize commercial processes using new technologies
  • Support manufacturing plant in Switzerland as a key opinion leader and process design expert.
  • Responsible for vendor selection, contract initiation and approval, technical review of agreements to support development and manufacturing.
  • Support and participate on cross-functional teams including Manufacturing, Regulatory, Quality Assurance, Analytical Sciences, and Drug Product Technologies to progress the Biologics portfolio.
  • Participate in due diligence and provide feedback on the process and manufacturing aspects.
    Qualifications (Minimal acceptable level of education, work experience, and competency)
    • PhD in chemical engineering, biochemistry or equivalent.
    • 15+ years of experience in biotechnology/biopharmaceutical/biosimlars industry with a track record of leadership and success.
    • Experience with early and late stage regulatory requirements especially as they apply to design space and process validation.
    • Experience with GMP as it applies to manufacturing and resolution of process deviations.
    • 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, MS&T, CROs and CMOs.
    • Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
    • Knowledge in antibody drug development.
    • Ability to travel up to 30%
      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.

      Job Information
      • Job ID: 55728457
      • Location:
        Wilmington, Delaware, United States Please refer to the company's website or job descriptions to learn more about them. United States 2 days ago Director to Executive Director, Immuno-Oncology... 2001 6th Ave, Suite 2700 Seattle, Washington 98121 (206) 956-3650

Keywords: The American College of Radiation Oncology, Boston , Sr. Director, Process Sciences, Executive , Wilmington, Massachusetts

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