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.
The Research Investigator will work within CMC Biologics Formulation and Drug Product Development organization and will research and develop viable formulation to support preclinical and clinical studies and robust and scalable manufacturing processes for monoclonal antibodies biologic products.
Essential Functions of the Job (Key responsibilities)
Design and conduct experiments to develop formulations, manufacturing processes for biologic products at different stages of development.
Participate in drug product development teams and contribute to the planning and execution of product development studies including all aspects of formulation and drug product process development, technology transfer, scale-up, and validation activities, based on project goals and timelines.
Design, execute, and interpret development studies based on defined project objectives by working closely with the drug product project lead and development team.
Generate high quality data based on sound scientific principles and summarize the results in technical reports, scientific papers, presentations, and regulatory documents.
Interact effectively with members of the Biologics Development department, and cross-functional internal and external partners.
Participate regulatory submission.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Ph.D in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 2 yrs of relevant industrial experience in formulation and drug product development of therapeutic protein products. MS/BS with a minimum of 5 years of relevant industrial experience will also be considered.
Scientific background and hands-on experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
Demonstrated experience in conducting experiments to evaluate the optimal formulations for biological products and establish robust process conditions for product manufacturing.
Technical expertise in at least one aspect of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging.
Basic understanding of the relationships between formulation, manufacturing process, and device design for the performance, quality, and stability of biological drug products.
Experience in statistical experimental design and data analysis including Design of Experiments (DoE).
Understanding and experience with GMP manufacturing and compliance preferred.
Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
Demonstrated ability for critical thinking, problem solving and creativity in the laboratory.
Strong organizational and planning skills.
Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate.
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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