Director, Pharmaceutical Development, Drug Product Manufacturing

Scorpion Therapeutics; Durham (NC); On-site; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior technical leader to oversee outsourced drug product development and manufacturing for its late‑stage biopharma portfolio focused on psychiatric and neurological indications, including psychedelics.

You will direct formulation and process strategy, technology transfer, validation, lifecycle management, and commercial readiness, while mentoring junior staff and coordinating with external partners and cross‑functional teams.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry or related field.
• 12+ years in pharmaceutical drug product development or CMC.
• Extensive experience with outsourced manufacturing, process validation, cGMP, and regulatory expectations for oral dosage products.

Responsibilities

• Lead formulation and process strategy.
• Manage manufacturing investigations, deviations, CAPAs, and change controls.
• Ensure regulatory compliance across programs.
• Lead secondary packaging development and regulatory submissions/supports.
• Manage external partners and cross-functional teams; mentor junior staff.

Skills

Leadership

Regulatory strategy

Vendor management

Process development

cGMP knowledge

Project management

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Job description

Role: Senior technical leader responsible for outsourced drug product development and manufacturing within a late-stage biopharma focused on psychiatric and neurological therapeutics, including psychedelics. Objectives include overseeing formulation, process development, technology transfer, validation, lifecycle management, and commercial readiness.

Responsibilities

serve as primary contact for CDMO oversight, lead formulation and process strategy, manage manufacturing investigations, deviations, CAPAs, and change controls; ensure regulatory compliance; lead secondary packaging development; support regulatory submissions and inspections; manage external partners and cross-functional teams; mentor junior staff.

Requirements

Bachelor's in Pharmaceutical Sciences, Chemistry, or related; 12+ years in pharmaceutical drug product development, manufacturing science, or CMC; extensive experience with outsourced manufacturing, process validation, cGMP, and regulatory expectations for oral dosage products; proven leadership in virtual/outsourced settings, influencing external partners, and contributing to regulatory strategies.

Preferred

experience with lifecycle management, regulatory submissions, statistical process monitoring, and mentoring.

High-Value

biologics or small molecules targeting neuropsychiatric indications, late-stage/clinical development, process validation, and commercial manufacturing.

Work setup and travel details are not specified.