Associate Director, CMC, Drug Product

Job summary

The Associate Director will lead non-clinical and early-phase clinical formulation and process development activities for small molecule drug products. They will manage CDMO relationships, oversee manufacturing activities, and ensure CMC documentation meets regulatory requirements for global filings.

Job details

The Associate Director will lead non-clinical and early-phase clinical formulation and process development activities for small molecule drug products. They will manage CDMO relationships, oversee manufacturing activities, and ensure CMC documentation meets regulatory requirements for global filings. Candidates must hold a PhD in a relevant scientific discipline with at least 10 years of experience in the pharmaceutical or biotech industry. Strong expertise in early-stage drug product development, cGMP compliance, and managing external manufacturing partners is required.

What you’ll do

The Associate Director will lead non-clinical and early-phase clinical formulation and process development activities for small molecule drug products. They will manage CDMO relationships, oversee manufacturing activities, and ensure CMC documentation meets regulatory requirements for global filings.

Requirements

Candidates must hold a PhD in a relevant scientific discipline with at least 10 years of experience in the pharmaceutical or biotech industry. Strong expertise in early-stage drug product development, cGMP compliance, and managing external manufacturing partners is required.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Short-term disability
• Long-term disability
• Accidental death and 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
• Target bonus

Listed skills

• Quality assurance · Preferred
• Leadership · Preferred
• Project management · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Drug product development
• CMC strategy
• Formulation development
• CDMO management
• Regulatory filings
• cGMP regulations
• Small molecule development
• Clinical supply management
• Project management
• Technical writing
• Quality assurance
• Analytical chemistry
• Process development
• Leadership
• Cross-functional collaboration
• Drug developability

Job areas

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

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