Remote Director, Drug Product Development & Manufacturing

Definium Therapeutics; Durham (NC); Remote; USD 230,000 - 260,000; Full time

Benefits offered by this job

100% paid health benefits including M,

401(k) with company match

Flexible time off

Generous parental leave

Job summary

Definium Therapeutics seeks a Director of Pharmaceutical Development to lead outsourced drug product manufacturing, packaging, and testing programs across early to late-stage development. The role emphasizes strategic vendor governance, technology transfer, scale-up, and lifecycle management in a virtual manufacturing environment.

The candidate will drive PPQ/CPV planning, process validation, and continuous improvement while aligning with regulatory expectations and commercial readiness through

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Minimum 12 years in pharmaceutical drug product development, manufacturing science, or related functions.
• Experience leading outsourced manufacturing models and CDMOs in virtual or highly outsourced environments.
• Strong knowledge of cGMP for OSD manufacturing; PPQ/CPV; regulatory expectations for late-stage development and commercial readiness.

Responsibilities

• Serve as senior technical lead for CDMOs supporting drug product manufacturing, packaging, testing, and release.
• Lead development strategy across programs including formulation, process development, scale-up, tech transfer, and commercial readiness.
• Oversee governance with external partners, cadence, risk management, and issue resolution.
• Mentor junior members and cross-functional partners in drug product development and manufacturing.
• Author/review CMC documentation for regulatory submissions and lifecycle management.

Skills

Leadership

CDMO management

Regulatory strategy

Technology transfer

Process validation

Risk assessment

Cross-functional coordination

Education

Bachelor’s in Pharmaceutical Sciences/Related

Job description

Definium Therapeutics seeks a Director of Pharmaceutical Development to lead outsourced drug product manufacturing, packaging, and testing programs across early to late-stage development. The role emphasizes strategic vendor governance, technology transfer, scale-up, and lifecycle management in a virtual manufacturing environment.

The candidate will drive PPQ/CPV planning, process validation, and continuous improvement while aligning with regulatory expectations and commercial readiness through