Senior Director, Manufacturing, Science and Technology (EDG-2025075)

Role Summary

Senior Director, Manufacturing, Science and Technology. Oversees late phase through commercialization drug product and drug substance manufacturing at partner CDMOs, ensuring high-quality products are delivered on time and within budget. Provides technical leadership for transfer of manufacturing processes to commercial scale, lifecycle management, and continuous improvement in a cGMP/regulatory context.

Responsibilities

• Lead the scale-up, and validation of manufacturing processes for both drug substance and drug product as well as finished goods packaging.
• Facilitate technology transfers, ensuring successful scale-up to commercial-scale production environments.
• Oversee CDMO qualification, contracting, and performance.
• Analyze existing processes, identify areas for improvement, and implement innovative technologies and strategies to optimize yield, reduce costs, and enhance efficiency.
• Provide technical expertise and actively troubleshoot and solve complex technical problems that arise during production.
• Manage and support manufacturing processes throughout their lifecycle, from validation through commercial operation.
• Work in collaboration with other teams to resolve technical challenges and meet program expectations, including RCMC, Quality Assurance, and Regulatory Affairs.
• Ensure that all manufacturing processes comply with relevant regulations and guidelines, including cGMP.
• Provide strategic leadership by directing and mentoring staff and fostering a culture of quality and innovation.
• Drive continuous improvement, implement best practices, and optimize manufacturing for efficiency and cost-effectiveness.
• Participate in the preparation of CMC sections for regulatory submissions, including for INDs and NDAs.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.

Qualifications

• Required: B.S. or M.S. in chemical engineering, pharmaceutical sciences or related field with an exceptional understanding of drug product development and manufacturing for solid oral dosage forms.
• Required: 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment.
• Required: 8+ years of management and oversight of CDMOs for cGMP activities.
• Required: Ability to navigate and craft global regulatory CMC documents.
• Required: Familiarity with safe and efficient laboratory practices.
• Required: General and scientific computer and software application proficiency.

Education

Additional Requirements

• Hybrid position; up to 30% travel.