Drug Product Development Lead — CDMO Strategy & Validation

Definium Therapeutics; Durham (NC); On-site; USD 150,000 - 202,000; Full time

Benefits offered by this job

100% paid health benefits including M,

401(k) with company match

Flexible time off

Parental leave

Job summary

Definium Therapeutics in the United States seeks an Associate Director of Drug Product Development to lead outsourced manufacturing strategies and CDMO collaborations. You will drive process development, tech transfer, scale-up, and validation, ensuring timelines align with late-stage programs.

The role requires deep expertise in drug product development, CPV/PPQ, and regulatory readiness, with leadership across virtual manufacturing activities and packaging development for commercial readiness.

Qualifications

• 10+ years of relevant experience in pharmaceutical drug product development, manufacturing science, technical operations, or related CMC functions.
• Experience supporting outsourced manufacturing models and managing CDMOs in a virtual company environment.
• Strong working knowledge of cGMP for OSD manufacturing, drug product development, and PPQ.
• ICH Q8/Q9/Q10 and risk-based validation principles.
• Proven ability to technically oversee and influence external manufacturing partners.

Responsibilities

• Serve as the technical contact for CDMOs supporting drug product development and release activities.
• Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation.
• Provide technical leadership for clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, and investigations as applicable.
• Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges, ensuring timely resolution of technical issues.
• Contribute to the development of process validation strategies for drug product manufacturing in collaboration with internal and external stakeholders.
• Oversee preparation, review, and approval of process validation documentation, including PPQ protocols/reports, risk assessments, control strategies, and CPV plans.
• Evaluate manufacturing performance data to identify trends and opportunities for improvement.
• Lead secondary packaging development activities for a drug product in late-stage development.
• Support packaging design inputs, labeling configuration, packaging line considerations, and secondary packaging validation with partners and stakeholders.

Skills

CDMO management

cGMP knowledge

Drug product development

Technology transfer

Risk-based validation

Education

Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or related

Job description

Definium Therapeutics in the United States seeks an Associate Director of Drug Product Development to lead outsourced manufacturing strategies and CDMO collaborations. You will drive process development, tech transfer, scale-up, and validation, ensuring timelines align with late-stage programs.

The role requires deep expertise in drug product development, CPV/PPQ, and regulatory readiness, with leadership across virtual manufacturing activities and packaging development for commercial readiness.