Senior Principal Investigator, Drug Product Process Development

Incyte Corporation; Wilmington (DE); Presencial; USD 180 000 - 260 000; Tempo integral

Resumo da oferta

Incyte Corporation in Wilmington, Delaware, seeks a Senior Principal Investigator, Drug Product Process Development to lead DP process development, validation, and regulatory submissions. You will coordinate with internal and external teams, manage CDMOs, and ensure timelines and budgets are met.

PhD/MS/BS with 15+ years in biopharma, hands-on cleanroom experience, and expertise across manufacturing steps from thawing to filling and labeling, with CDMO management and risk investigations.

Qualificações

• PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with 15+ years of experience in biopharmaceutical industry.
• Hands-on experience 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 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.

Responsabilidades

• 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

Conhecimentos

Process development

Regulatory submissions

CDMO management

Quality Assurance collaboration

Documentation

Project management

Communication skills

Formação académica

PhD in Biochemistry / Chemical Engineering or related field

Descrição da oferta de emprego

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.