Overview Job description The Senior Principal Investigator Drug Product Process Development will report to the senior director 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. Individuals who are self-motivated enthusiastic team players with a passion for playing a key role in the development of life-saving medicines are encouraged to apply. Expertise and experience in large moleculebiologics 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. Incyte is a fast-paced biopharmaceutical company of passionate employees and there is substantial opportunity for the ideal candidate to grow and develop with the organization. Individuals will have the opportunity to work on projects and take on responsibilities that may fall outside hisher immediate scope of work. The job is based in Wilmington Delaware US. Essential Duties and Responsibilities • Design and develop phase appropriate processmanufacturing to support preclinical and clinical studies. • Design and oversee execution of drug product activities in preparation for registration and validation and commercial activities. • Manage and execute PrimaryRegistration batch manufacturing aligned with regulatory filings. • Lead in RFP writing technical transfer process and method development optimization qualification validation and activities related to all manufacturing operations. • Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs negotiate effective supplytechnical agreements. • Work closely with contract manufacturers CMOs Supply Chain leads Quality and operations partners to ensure supply continuity with optimal cost and quality. • 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 INDIMPD INDIMPD amendments BLA and response to queries from global regulatory authorities Investigators Brochure and Pharmacy Manual. • Ensures that key project milestones and schedules are met. • Manage consultants vendors and CDMOs to meet agreed upon program timelinesbudgets. • Travel to various CDMO sites 15 • Other projects as deemed appropriate KnowledgeSkillsAbilities Required PhDMSBS in Biochemistry Chemical Engineering or related field with 15 years of experience in biopharmaceutical industry. Hands-on experience working in a cleanroom 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 working closely with the Quality Assurance and Clinical Supply Chain Management functions. Experience in risk management deviation and root-cause investigations and CAPAs. Experience in writing CMC sections of IND and BLA. Experience in formulation development lyophilization cycle development drug product process characterization and validation equipment validation and cleaning validation are highly desired. Must be proactive detail-oriented collaborative and able to work effectively in a fast-paced environment with minimal supervision. Excellent communication organization and collaborative skills are essential. 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. We Respect Your Privacy Learn more at httpwww.incyte.comprivacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access delete restrict edit move or object to the use of your personal data. 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