Director of Product Development

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manage and oversee activities and contractual relationship with Contract Manufacturing Organizations (CMOs) performing process scale-up development, technology transfer, and manufacturing of drug product.
• Lead and collaborate with cross functional project team members to meet operational, quality, and CMC goals.
• Write Request for Proposal and negotiate contracts and agreements.
• Evaluate and select contract manufacturers.
• Thoroughly review and approve master and executed manufacturing and packaging batch records.
• Provide manufacturing summary reports.
• Assist in preparation of regulatory documentation for IND and NDA submissions.
• Work closely with CMC project managers, CTM supply chain manager, and drug substance team to plan and coordinate manufacturing activities to meet clinical supply projection.
• Troubleshoot manufacturing related issues. Make decisions and recommendations.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

• Master’s degree in pharmaceutical sciences, chemistry, chemical engineering or relevant area.
• 8+ years relevant industry experience with increasing responsibility.
• Extensive experience with process scale-up and manufacturing of oral solid dosage forms.
• Prior experience with QbD (Quality by Design) and process validation is a plus.
• Proven track record of CMO management.
• Experience in compiling technical information for manufacturing and control of critical steps to support regulatory submissions.
• Thorough understanding of drug product GMPs and quality systems.
• Excellent written and oral communication skills.
• Strong organizational and problem solving skills.
• Willing to travel up to 30% of time.