Sr. Director, CMC – Precursor Development & Manufacturing

About the role

The Sr. Director, CMC - Precursor Development & Manufacturing is responsible for the development, optimization, manufacturing, and lifecycle management of precursor molecules and related reference standards used in the Company's radiopharmaceutical products. This role provides technical leadership across synthetic chemistry, process development, analytical development, and GMP manufacturing of complex small molecules, including peptide-based and chelator-containing precursors.

Responsibilities

• Lead process development, optimization, and scale-up for precursor molecules and reference standards, including small molecules and peptide-based constructs
• Provide subject matter expertise in synthetic organic and process chemistry, including route design, impurity control, and process robustness
• Partner with the Associate Director of Analytical Development to guide analytical development activities and ensure methods are GMP-ready, fit for intended use, and capable of supporting manufacturing, release, and stability programs
• Ensure GMP-compliant manufacturing of precursor materials at CDMOs
• Support technology transfer and scale-up activities for clinical and commercial manufacturing
• Ensure CMC activities align with ICH guidelines and global regulatory requirements for drug substance development
• Prepare and review CMC documentation for regulatory submissions (e.g., IND/CTA/MAA)
• Partner with Quality Assurance on deviations, investigations, change controls, and audit readiness
• Drive continuous improvement in process efficiency, robustness, and cost of goods
• Support material specifications, control strategies, and impurity fate and purge assessments
• Provide technical input to supply chain planning and risk mitigation strategies
• Mentor and develop CMC staff and foster a strong technical culture
• Observe the Company's workplace, health and safety, and regulatory policies and procedures
• Engage and communicate with other AdvanCell business unit staff to ensure that activities are coordinated seamlessly and effectively
• Adhere to the Company's quality management system processes and policies
• Other tasks as requested by the VP, CMC and Supply Chain

Qualifications

• Ph.D. in Chemistry (preferably Organic or Process Chemistry) or related discipline
• Significant industry experience (typically 6+ years) in CMC, process development, or technical operations
• Strong expertise in synthetic chemistry, including multi-step synthesis and impurity control
• Working knowledge of analytical development and validation (e.g., HPLC, LC-MS, stability-indicating methods)
• Advanced knowledge of GMP manufacturing and regulatory expectations
• Strong understanding of ICH guidelines and global regulatory requirements
• Demonstrated experience selecting and managing CDMOs and external partners
• Excellent problem-solving, communication, and leadership skills
• Ability to operate independently and effectively in a fast-paced, development-stage environment
• Demonstrated ability to deliver to timelines in high-pressure environments

Desirable skills

• Experience in radiopharmaceutical or radiochemistry environments
• Familiarity with chelator chemistry and metal complexation
• Experience supporting regulatory submissions (e.g., IND/CTA/NDA/MAA)
• Knowledge of CMC strategies for early- and late-phase development