Principal Investigator, Drug Product Technologies

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 Principal Research Investigator, Drug Product Technologies will work within the Global Biopharmaceutical Development, Drug Product Technology organization and will research and develop viable formulations and robust and scalable manufacturing processes for monoclonal antibodies and bispecific biologic products to support preclinical, clinical studies and commercial use.

Essential Functions of the Job (Key responsibilities)

• Will interact effectively with members of the Global Biopharmaceutical Development department, and cross-functional internal and external partners.
• Will collaborate with Contract Research and Contract Manufacturing Organizations (CROs and CMOs) to generate high quality data based on sound scientific principles and summarize the results in technical reports, scientific papers, presentations, and regulatory documents.
• Will design, execute, and interpret development studies based on defined project objectives.
• Will 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.
• The successful candidate will conduct objective research to develop formulations (liquid or Lyo DP), manufacturing processes, primary container configurations for biologic products and combination product at different stages of development.
• Will write technical reports and be authors of IND/IMPD, BLA and other regulatory filing documents.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Strong organizational and planning skills.
• Demonstrated ability for critical thinking, problem solving and creativity.
• Proven ability to work effectively in team structures and collaborate with cross-functional internal/external partners.
• Experience with process characterization, validation, risk assessment, and control strategies of protein drug products.
• Experience in statistical experimental design and data analysis including Design of Experiments (DoE).
• Technical expertise in aspect of drug product development and/or manufacturing processes, including formulation, compounding, sterile processing, filling, lyophilization, and primary packaging. Understanding the relationships between formulation, manufacturing process, and device design for the performance, quality, and stability of biological drug products.
• Scientific background and practical experience in protein formulation, biologic drug product process development for liquid and lyophilized products, and biophysical characterization of proteins. Experience in developing optimal formulations for biological products and establishing robust process conditions for manufacturing.
• In-depth understanding of the requirements for IND/IMPD, BLA submissions and other regulatory filing documents.
• Degree (such as Ph.D/MSc/BS) in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with significant experience in formulation and drug product development of therapeutic protein products.
• Strong written and verbal communication skills, excellent interpersonal skills, ability to manage multiple tasks, proven track record in publications, 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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