Director, CMC – Precursor Development & Manufacturing

The 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.

The successful candidate will work closely with external contract development and manufacturing organizations (CDMOs) to build process understanding, support analytical method development and validation, and ensure alignment with global regulatory expectations (e.g., ICH, GMP). This work enables the timely delivery of high-quality drug substance and reference standards for clinical and commercial manufacturing. The Director also supports CDMO selection and shipping logistics for precursor materials.

The role also includes leading CMC regulatory writing and documentation to support regulatory submissions for precursors and related reference standards.

Key Responsibilities and Duties

• 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

Other Responsibilities

• 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

Essential Skills, Qualifications, Industry and Educational Requirements

• 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, Qualifications, Industry and Educational Requirements

• 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