Senior Principal Investigator, DP Process Development

Incyte; Wilmington (DE); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Incyte in Wilmington, DE seeks a Senior Principal Investigator in Drug Product Process Development to lead biologics DP development and validation efforts, and to manage CMC content for regulatory submissions. You will collaborate with internal teams and external CDMOs to ensure timelines and quality across development programs.

Responsibilities include process development, validation, technology transfer, and regulatory documentation, with opportunities to influence program strategy and

Qualifications

• PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with 15+ years of experience in biopharmaceutical industry.
• Hands-on experience in cleanroom environments and biologics drug product manufacturing.
• Experience in CMC sections writing for IND/BLA and regulatory interactions.

Responsabilités

• Design and develop phase-appropriate drug product processes for preclinical and clinical studies.
• Oversee manufacturing activities for registration, validation, and commercial use.
• Manage primary/registration batch manufacturing aligned with regulatory filings.
• Lead transfer, process and method development, qualification, validation, and CDMO interactions.
• Evaluate third-party manufacturers with QA and Regulatory Affairs; negotiate supply/technical agreements.
• Coordinate with CMOs, Supply Chain, QA and Ops to ensure supply continuity and quality.
• Participate in cross-functional project teams as CMC representative.
• Author/review drug product sections for regulatory submissions (IND/IMPD, BLA, responses).
• Ensure milestones and schedules are met; manage consultants and CDMOs.
• Travel to CDMO sites (~15%).
• Other projects as assigned.

Connaissances

Biologics process development

CDMO management

Regulatory submissions (CMC)

Cross-functional collaboration

Risk management

Formation

PhD/MS/BS in Biochemistry or Chemical Engineering

Description du poste

Incyte in Wilmington, DE seeks a Senior Principal Investigator in Drug Product Process Development to lead biologics DP development and validation efforts, and to manage CMC content for regulatory submissions. You will collaborate with internal teams and external CDMOs to ensure timelines and quality across development programs.

Responsibilities include process development, validation, technology transfer, and regulatory documentation, with opportunities to influence program strategy and