Senior Biologics DP Process Development Lead

Biopharma Careers; Wilmington (DE); On-site; USD 180,000 - 260,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Biologics

Cross-functional leadership

Regulatory knowledge

Process development

CDMO management

Quality Assurance coordination

IND/BLA writing

Education

PhD in Biochemistry/Chemical Engineering

MS in related field

BS in related field

Tools

CMC writing experience

Regulatory submission planning

Job description

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