Senior Director, Manufacturing, Science and Technology

Role Summary

Senior Director, Manufacturing, Science and Technology responsible for overseeing late-phase through commercialization drug product and drug substance manufacturing, leading technology transfers to commercial scale, and ensuring compliance, quality, and efficiency across internal and CDMO operations.

Responsibilities

• Lead the scale-up and validation of manufacturing processes for drug substance, drug product, and finished goods packaging.
• Facilitate technology transfers to commercial-scale production environments.
• Oversee CDMO qualification, contracting, and performance.
• Analyze existing processes, identify improvements, and implement technologies to optimize yield, reduce costs, and enhance efficiency.
• Provide technical expertise and troubleshoot complex manufacturing problems during production.
• Manage and support manufacturing processes throughout their lifecycle from validation through commercial operation.
• Collaborate with teams to resolve technical challenges and meet program expectations (CMC, Quality Assurance, Regulatory Affairs).
• Ensure manufacturing processes comply with regulations and guidelines, including cGMP.
• Provide strategic leadership by directing and mentoring staff and fostering a culture of quality and innovation.
• Drive continuous improvement and optimize manufacturing for efficiency and cost-effectiveness.
• Participate in preparing CMC sections for regulatory submissions (INDs and NDAs).
• Adhere to workplace health and safety policies and company procedures.
• Perform other duties as assigned by supervisor.

Qualifications

• Required: B.S. or M.S. in chemical engineering, pharmaceutical sciences, or related field with strong 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 proficiency with common computer and software applications

Skills

• Technical leadership in manufacturing processes and technology transfer
• Strong problem-solving and troubleshooting abilities
• Project and lifecycle management for manufacturing processes
• Collaboration with cross-functional teams (CMC, Quality, Regulatory)
• Regulatory compliance knowledge (cGMP)

Education

• B.S. or M.S. in chemical engineering, pharmaceutical sciences or related field

Additional Requirements

• Hybrid work arrangement; up to 30% travel