Senior Principal Investigator, Drug Product Process Development

Biopharma Careers; Wilmington (DE); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

Incyte in Wilmington, Delaware, seeks a Senior Principal Investigator, Drug Product Process Development to lead phase-appropriate biologics manufacturing development, validation and CDMO coordination. The role reports to the Senior Director of DP Technologies and offers ownership across preclinical to commercial processes.

You will design manufacturing steps, author CMC sections, and collaborate with QA, regulatory, supply chain, and contract manufacturers to meet timelines while traveling up to

Qualifications

• PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with 15+ years of experience in biopharma.
• Hands-on experience in drug product manufacturing of biologics and cleanroom environments.
• Experience with CDMO management, QA collaboration, and regulatory interactions.

Responsabilités

• Design and develop phase-appropriate drug product processes for preclinical and clinical studies.
• Lead registration/validation activities and support regulatory submissions.
• Manage and coordinate CDMOs, vendors, and cross-functional teams to meet milestones.
• Author and review CMC sections for IND/BLA submissions and inquiries.
• Travel to CDMO sites as needed (around 15%).
• Collaborate with QA, Regulatory, and Supply Chain to ensure supply continuity.

Connaissances

Biologics

Cross-functional leadership

Regulatory knowledge

Process development

CDMO management

Quality Assurance coordination

IND/BLA writing

Formation

PhD in Biochemistry/Chemical Engineering

MS in related field

BS in related field

Outils

CMC writing experience

Regulatory submission planning

Description du poste

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 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. 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 his/her immediate scope of work. The job is based in Wilmington Delaware, US.

Essential Duties and Responsibilities:

• Design and develop phase appropriate process/manufacturing 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 Primary/Registration 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 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.
• 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 CDMO sites (15%)
• Other projects as assigned

Knowledge/Skills/Abilities Required:

PhD/MS/BS 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 (Biologics License Application) 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: http://www.incyte.com/privacy-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. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). Please contact [e-mail] if you have any questions or concerns or would like to exercise your rights. vwd VWD