Director, CMC – Precursor Development & Manufacturing

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