at Incyte Corporation in Wilmington, Delaware, United States
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 motivated individual to lead our Cell Culture Process Science team. The Associate Director/Director, Cell Culture Process Science has direct oversight of the internal cell culture development group performing cell culture process development for Phase I-III and post-approval changes. Team also oversees technology transfer and participates in clinical/commercial manufacture at CMOs and internal facilities. The Associate Director/Director provides leadership for the development, technology transfer and execution of drug substance manufacturing programs at CMOs and internal facilities to successfully support IND submissions to BLA approvals. This position works with collaborators/partners and CMOs to participate in cross-functional teams.
Essential Functions of the Job (Key responsibilities)
Oversee cell culture manufacture process development, technology transfer to internal and CMO-based manufacturing of large molecules, including but not limited to monoclonal and bi-specific antibodies in early to late stage clinical development as well as commercial launch.
Provide technical support to CMOs/partners in cell culture fermentation process, such as optimization of process performance at various manufacturing scales, through an understanding of engineering and biological factors that influence process performance and product quality, process scale-up, batch record updates/review/approval, as needed.
Collaborates with the development team in the internal manufacturing facility during and after technology transfer to ensure process knowledge is correctly documented and transferred.
Ensure scalable, commercially-viable biological manufacturing processes are properly developed, implemented and characterized as necessary. Contributes to process validation activities leading to commercial approval.
Oversee internal cell culture lab responsible for process, media, and technology development as well as pilot scale material generation for antibody discovery and GLP toxicology studies.
Plan, create and manage the execution of process characterization protocols for biopharmaceutical manufacturing processes.
Provide engineering support to manufacturing process to improve efficiency, sustain product quality, and reduce cost of goods.
Establish and communicate key project milestones and manage timelines for multiple manufacturing campaigns occurring at different manufacturing sites globally.
Qualifications (Minimal acceptable level of education, work experience, and competency)
PhD in biochemical engineering, chemistry or equivalent and a minimum of 7-10 years of relevant industry experience or a MS degree in chemical engineering, biochemical engineering or relevant related field and a minimum of 8-12 years of relevant industry experience or equivalent.
Minimum of 5 years process operations experience supporting cGMP manufacturing facilities preferred.
Experience in development of robust processes, new technology implementation (i.e ATF, media and feeds, PAT), and establishment of cell culture platforms.
Demonstrate technical proficiency in biologic drug substance manufacturing processes (particularly monoclonal antibodies) focusing on cell culture operations from pilot to Phase 3/commercial scale.
Excellent verbal and written communication skills required.
Good inter-personal skill to work with regulatory, QA, QC, CRO and CMO.
Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
Prior experience working with ex-US business partners, and familiarity with ex-US Regulatory guidelines preferred.
Direct experience in preparing and reviewing CMC documentation for regulatory filings to support global regulatory submissions from IND to BLA as well as regulatory inspections.
Travel required, as needed - occasional international travel to partner(s) and CMO facilities.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees... For full info follow application link.
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