Sr. Director, Process Sciences
Company: The American College of Radiation Oncology
Posted on: February 25, 2021
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
The Company strives to discover and develop first-in-class and
best-in-class medicines-advancing a diverse portfolio of large and
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
- 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
- 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
- Support and participate on cross-functional teams including
Manufacturing, Regulatory, Quality Assurance, Analytical Sciences,
and Drug Product Technologies to progress the Biologics
- 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
- 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.
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is optional, sources of the personal data we process, how it is
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- Job ID: 55728457
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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