Senior Director, Commercial Manufacturing, Science and Technology

• Lead commercial drug product CMC lifecycle activities such as post-approval change management, process validation product risk management and process monitoring.
• Facilitate technology transfers, ensuring successful scale-up to commercial-scale production environments. 
• Serve as Primary technical point of contact with the CDMO's. Establish and monitor KPI's.
• 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. 
• Lead cross functional teams to resolve technical challenges and meet program expectations, including Reg CMC and Quality Assurance.
• 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. 

• Provide regulatory filings support by authoring and reviewing CMC sections of IND, IMPD, NDA or other filings as

Qualifications:

• PhD, MS or BS in chemical engineering, pharmaceutical sciences or related field with an exceptional understanding of drug product development and manufacturing for small molecule solid oral dosage forms
• 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment

• 12+ years of management and oversight of CDMOs for cGMP activities for late stage and commercial assets
• Experience in manufacturing techniques such as advanced drug delivery systems for enhancing drug permeability and/or solubility and other manufacturing processes including blending, granulation, tablet compression, film coating etc.
• Extensive experience in outsourcing, vendor selection and managing CMOs for scale up, tech transfer, process validation, and commercial manufacturing.
• Extensive knowledge of cGMP requirements for drug product manufacture as well as broader drug development guidelines (ICH, FDA, and EMA) and past experience in regulatory filings.
• Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory filings.
• Attention to detail and quality with critical thinking.
• 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment
• 8+ years of management and oversight of CDMOs for cGMP activities
• Ability to navigate and craft global regulatory CMC documents
• Familiarity with safe and efficient laboratory practices
• General and scientific computer and software application proficiency
• Up to 30% travel.
• This position requires technical leadership skills; interaction with all levels of employees; and the ability to direct, coach, and evaluate the operational activities of lower-level employees as well as influencing others in a matrix team leadership environment.
• Manages the coordination of the activities of a section or department with responsibility for results. In some instances, this manager may be responsible for a functional area and not directly supervise employees.

Salary Range:

$240,000 - 280,000 USD