Senior 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 Sr. Principal Investigator, Drug Product Technologies, reporting to DP Technologies (DPT) in Global Biopharmaceutical Development (GBD), is a critical role in our development team and will help lead the successful development and commercialization of biologics product candidates.
The successful incumbent in this role will be a self-motivated, enthusiastic team player with a passion for playing a key role in the development of life-saving medicines. Expertise and experience in large molecule/biologics DP process development and validation and CDMO management are required. The incumbent will work with internal and external team members to meet Company timelines and objectives. Responsibilities include but not limit to drug product process development, process validation as well as preparation of CMC sections for regulatory submissions and updates.

Essential Functions of the Job (Key responsibilities)

• Design and develop phase appropriate process/manufacturing to support preclinical and clinical studies.
• Lead in RFP writing, technical transfer, process and method development, optimization, qualification, validation, and activities related to all manufacturing operations, ensuring inclusive practices and diverse perspectives are considered.
• Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, negotiate effective supply/technical agreements.
• Work closely with contract manufacturers (CMOs), Supply Chain leads, Quality and operations partners to ensure supply continuity with optimal cost and quality.
• Manage Interactive Response Technology (IRT) systems from specification, user acceptance testing and release to support randomization and management of CTM.
• Manage investigation, reporting and communication of outcomes from temperature excursions, product complaints, etc.
• Design and oversee execution of drug product activities in preparation for registration and validation, and commercial activities.
• Manage and execute Primary/Registration batch manufacturing aligned with regulatory filings.
• Participate in cross functional project teams for product development as CMC functional area representative.
• Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator's Brochure and Pharmacy Manual.
• Ensures that key project milestones and schedules are met.
• Manage consultants, vendors, and CDMOs to meet agreed upon program timelines/budgets.
• Travel to various CMOs sites (20%).

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

• Degree (such as PhD/MS/BS) in Biochemistry, Chemical Engineering, or related field with significant experience in the biopharmaceutical industry. 
• Practical experience working in a controlled environment and in drug product manufacturing of biologics.
• Experience and knowledge in the entire drug product manufacturing process, from drug substance thawing and compounding, sterile filtration, filling, stoppering, lyophilization, capping, to visual inspection and labeling.
• Familiar with filtration systems, filling lines, filling isolators, and environmental monitoring.
• Experience in CDMO management and collaborating effectively with the Quality Assurance and Clinical Supply Chain Management teams.
• Experience in risk management, deviation and root-cause investigations, and corrective and preventive actions (CAPAs).
• Experience in writing Chemistry, Manufacturing, and Controls (CMC) sections of Investigational New Drug (IND) and Biologics License Application (BLA) submissions.
• Must be proactive, detail-oriented, collaborative, and able to work effectively in a dynamic environment with minimal supervision.
• Excellent communication, organization, and collaborative skills are essential.
• Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly valued.

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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