Senior / Executive Director, Analytical Development CMC
JOB SUMMARY
Iambic Therapeutics is seeking a Senior or Executive Director to lead the analytical development and QC function within CMC. This leadership role will provide scientific, strategic, and operational oversight of Analytical Development and Quality Control activities across Iambic’s small-molecule portfolio, supporting programs from early clinical development through late-stage development and commercialization. The individual will lead phase-appropriate analytical strategies for drug substance and drug product, including analytical method development, transfer and validation, specifications, impurity control, stability, reference standards, product characterization, and release testing. The role will serve as the primary Analytical Development/QC lead for internal cross-functional teams and external CDMOs/testing labs, ensuring high-quality, compliant, and timely execution of analytical activities in accordance with applicable regulatory requirements and company procedures.
KEY RESPONSIBILITIES
Lead DS and DP analytical strategy and scientific oversight across characterization, impurity and degradation-product control, reference standards, comparability, and stability, with responsibility for shelf-life/retest assessment and emerging stability risks.
