Director/Senior Director, CMC, Drug Product Manufacturing (Late Stage/Commercial)

Job summary

The Director, CMC, Drug Product oversees late-stage process development, validation, and commercial manufacturing of drug products through external partners. They are responsible for ensuring regulatory compliance, managing CDMO relationships, and providing strategic oversight for CMC documentation and submissions.

Job details

The Director, CMC, Drug Product oversees late-stage process development, validation, and commercial manufacturing of drug products through external partners. They are responsible for ensuring regulatory compliance, managing CDMO relationships, and providing strategic oversight for CMC documentation and submissions. Candidates must hold a PhD in a relevant scientific discipline with at least 10 years of management experience in the pharmaceutical or biotech industry. Extensive expertise in late-stage drug product manufacturing, commercialization, and cGMP regulations is required.

What you’ll do

The Director, CMC, Drug Product oversees late-stage process development, validation, and commercial manufacturing of drug products through external partners. They are responsible for ensuring regulatory compliance, managing CDMO relationships, and providing strategic oversight for CMC documentation and submissions.

Requirements

Candidates must hold a PhD in a relevant scientific discipline with at least 10 years of management experience in the pharmaceutical or biotech industry. Extensive expertise in late-stage drug product manufacturing, commercialization, and cGMP regulations is required.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Short-term disability
• Long-term disability
• Accidental death & dismemberment insurance
• Life insurance
• Employee assistance program
• Travel insurance
• Retirement savings program
• Company matching contributions
• Vacation
• Personal days
• Sick days
• Tuition assistance program
• Stock options

Listed skills

• Supply Chain · Preferred
• Quality assurance · Preferred
• Leadership · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• CMC
• Drug product development
• Process validation
• Commercial manufacturing
• CDMO management
• Small molecule
• Regulatory affairs
• cGMP
• FMEA
• Scale-up
• Formulation development
• Project management
• Leadership
• Strategic planning
• Quality assurance
• Supply chain

Job areas

• Science & Research
• Manufacturing
• Management & Leadership
• Healthcare
• Engineering

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