Senior Principal Investigator, Drug Product Technologies
Incyte
July 01, 2026
Remote friendly (Wilmington, DE)
United States
Operations
Job Summary (Primary Function)
- Sr. Principal Investigator, Drug Product Technologies (DP Technologies, Global Biopharmaceutical Development): Lead development and commercialization of biologics product candidates, including drug product process development, process validation, and preparation of CMC sections for regulatory submissions and updates.
Key Responsibilities
- Design and develop phase-appropriate process/manufacturing to support preclinical and clinical studies.
- Lead RFP writing, technical transfer, process/method development, optimization, qualification, validation, and manufacturing operations (inclusive practices).
- Evaluate third-party manufacturers with Quality Assurance and Regulatory Affairs; negotiate supply/technical agreements.
- Partner with CMOs, Supply Chain, Quality, and Operations to ensure supply continuity with optimal cost and quality.
- Manage Interactive Response Technology (IRT) systems (specification, UAT, release) to support randomization/CTM management.
- Manage and communicate outcomes from temperature excursions and product complaints.
- Design/oversee drug product activities for registration, validation, and commercial readiness.
- Manage and execute Primary/Registration batch manufacturing aligned with regulatory filings.
- Serve as CMC functional area representative on cross-functional project teams.
- Author/review drug product regulatory sections (IND/IMPD, BLA, amendments, query responses, Investigator’s Brochure, Pharmacy Manual).
- Ensure key milestones and schedules are met.
- Manage consultants, vendors, and CDMOs to meet timelines/budgets.
- Travel to CMOs sites (20%).
Qualifications & Required/Preferred Skills
- PhD/MS/BS in Biochemistry, Chemical Engineering, or related field; significant biopharmaceutical industry experience.
- Biologics drug product manufacturing experience in controlled environments.
- Knowledge of end-to-end drug product process: thawing/compounding, sterile filtration, filling, stoppering, lyophilization, capping, visual inspection, labeling.
- Familiarity with filtration systems, filling lines, filling isolators, and environmental monitoring.
- CDMO management experience; collaboration with Quality Assurance and Clinical Supply Chain.
- Risk management, deviations, root-cause investigations, CAPAs.
- Experience writing CMC sections for IND and BLA submissions.
- Proactive, detail-oriented, collaborative; strong communication/organization.
- Highly valued: formulation development, lyophilization cycle development, process characterization/validation, equipment validation, cleaning validation.
- Sr. Principal Investigator, Drug Product Technologies (DP Technologies, Global Biopharmaceutical Development): Lead development and commercialization of biologics product candidates, including drug product process development, process validation, and preparation of CMC sections for regulatory submissions and updates.
Key Responsibilities
- Design and develop phase-appropriate process/manufacturing to support preclinical and clinical studies.
- Lead RFP writing, technical transfer, process/method development, optimization, qualification, validation, and manufacturing operations (inclusive practices).
- Evaluate third-party manufacturers with Quality Assurance and Regulatory Affairs; negotiate supply/technical agreements.
- Partner with CMOs, Supply Chain, Quality, and Operations to ensure supply continuity with optimal cost and quality.
- Manage Interactive Response Technology (IRT) systems (specification, UAT, release) to support randomization/CTM management.
- Manage and communicate outcomes from temperature excursions and product complaints.
- Design/oversee drug product activities for registration, validation, and commercial readiness.
- Manage and execute Primary/Registration batch manufacturing aligned with regulatory filings.
- Serve as CMC functional area representative on cross-functional project teams.
- Author/review drug product regulatory sections (IND/IMPD, BLA, amendments, query responses, Investigator’s Brochure, Pharmacy Manual).
- Ensure key milestones and schedules are met.
- Manage consultants, vendors, and CDMOs to meet timelines/budgets.
- Travel to CMOs sites (20%).
Qualifications & Required/Preferred Skills
- PhD/MS/BS in Biochemistry, Chemical Engineering, or related field; significant biopharmaceutical industry experience.
- Biologics drug product manufacturing experience in controlled environments.
- Knowledge of end-to-end drug product process: thawing/compounding, sterile filtration, filling, stoppering, lyophilization, capping, visual inspection, labeling.
- Familiarity with filtration systems, filling lines, filling isolators, and environmental monitoring.
- CDMO management experience; collaboration with Quality Assurance and Clinical Supply Chain.
- Risk management, deviations, root-cause investigations, CAPAs.
- Experience writing CMC sections for IND and BLA submissions.
- Proactive, detail-oriented, collaborative; strong communication/organization.
- Highly valued: formulation development, lyophilization cycle development, process characterization/validation, equipment validation, cleaning validation.