Executive Director, Process Sciences

InCyte•Wilmington, DE

52d

About The Position

Overview 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 Executive Director, Process Sciences provides leadership to Incyte Biologics specifically in the area of cell line development, cell culture and purification of monoclonal and bi-specific antibodies, ensuring an inclusive and diverse team environment. This position will have a scope of responsibility that includes collaborating with Discovery to advance molecules from pre-clinical to clinical stages, subsequently preparing the process and technology for commercial manufacture to deliver a successful BLA package. As a key opinion leader and key contributor, the person in this position will collaborate with commercial facilities for process validation and play an instrumental role in establishing best practices for technology transfer to both internal and external DS manufacturing facilities.

Requirements

Advanced degree (such as PhD) in chemical/biochemical engineering, biochemistry, or related field, or equivalent experience.
At least 15 years of extensive experience in biotechnology/biopharmaceutical/biosimilars industry with a track record of success.
Demonstrated experience in leading teams and achieving successful outcomes in a fast-paced, lean environment.
Experience with Good Manufacturing Practices (GMP) as it applies to manufacturing and resolution of process deviations.
Proficient in study design, protocol and technical report writing and review.
Strong communication skills, both verbal and written, are essential.
Strong interpersonal skills to collaborate effectively with regulatory, QA, MS&T, CROs and CMOs.
Willingness to travel 10-20% or more as needed, both domestic and international, with reasonable accommodations available for individuals with disabilities.

Nice To Haves

Experience with regulatory requirements across all stages of development, especially as they apply to design space and process validation, is preferred.

Responsibilities

Efficiently deliver cell line and manufacturing process using existing platform suitable to enable First-In-Human (FIH) clinical trials.
Ensure global regulatory filings and responses to health authorities are clearly written and suitable 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 diverse talent, and managing internal labs.
Identify new technologies to evaluate and oversee the development of a next generation process sciences platform.
Lead or play a key role in technology transfer governance and approaches both internally and ensuring inclusive and diverse perspectives are considered.
Lead successful, timely and comprehensive completion of FMEA, process characterization, process validation strategy, and regulatory submissions.
Optimize commercial processes using new technologies throughout life cycle management.
Support the internal Drug Substance manufacturing plant in Europe as a key opinion leader and process design expert.
In agreement with other parts of Global Biopharmaceutical Development (GBD) identify new vendors, contract initiation and review of technical agreements to support development and transfer of production processes.
Serve as Technical Operations representative and CMC sponsor on Global Program Teams as needed.
Support and participate in cross-functional teams including Manufacturing, Regulatory, Quality Assurance, Analytical Sciences, and Drug Product Technologies to progress the Biologics portfolio while fostering an inclusive environment for all team members.
Participate in due diligence and provide feedback on the process and manufacturing aspects.