Senior / Executive Director, Analytical Development CMC

Другое

• JOB SUMMARY
• Company 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
• 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.
• Lead analytical method development, validation, transfer, lifecycle management, and troubleshooting across DS and DP, ensuring methods are fit for purpose, scientifically sound, and aligned with regulatory expectations.
• Oversee QC testing and data review for release and stability, including OOS/OOT investigations, deviations, root-cause assessment, CAPAs, and resolution of analytical issues.
• Establish scientifically justified specifications and analytical acceptance criteria based on product and process understanding, batch history, stability data, and stage of development.
• Provide analytical leadership for dissolution and product-performance testing, including development of QC and discriminatory methods for oral drug products.
• Lead the outsourced analytical and QC network, including partner selection, technical oversight, governance, issue resolution, and performance management.
• Ensure analytical activities support program timelines and manufacturing readiness through close partnership with Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other cross-functional teams.
• Lead analytical CMC support for global regulatory submissions and health authority interactions, including authoring and review of relevant Module 3 content, specifications and justifications, analytical methods, stability sections, and responses to regulatory queries.
• Recruit, lead, coach, and develop team members; oversee functional resource planning and budget proposals; and foster a collaborative, high-performing environment aligned with organizational goals.
• QUALIFICATIONS
• Ph.D. in Analytical Chemistry or a related field with 12+ years of experience in the pharmaceutical/Biotech industry (or an M.Sc . with 14+ years or B.Sc . with 17+ years of experience).
• Extensive hands-on experience in analytical method development, transfer, troubleshooting, and validation for small molecule drug substance (DS) and drug product (DP) across early and late-stage development.
• Strong experience developing phase-appropriate analytical control strategies, including specifications, impurity/degradation-product control, reference standards, stability-indicating methods, dissolution, and product characterization.
• Demonstrated experience supporting early and late-stage development and regulatory filings, including IND/IMPD and preferably NDA/MAA.
• Proven success leading Analytical Development and QC activities through external CDMOs, including technical oversight, issue resolution, and management of multiple programs and partners.
• In-depth knowledge of cGMP laboratory operations, global regulatory expectations and relevant ICH guidance.
• Strong experience with analytical methods for enabling formulations and conventional oral solid dosage forms.
• Proven leadership experience in building collaborative, high-performing teams and working effectively across Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other functions.
• Excellent written and verbal communication skills, with the ability to communicate technical issues, risks, and recommendations to internal stakeholders, external partners, and health authorities.
• Ability to travel up to 15% domestically and internationally.
• ABOUT Company
• Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at.
• MISSION & CORE VALUES
• Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Company are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
• PAY AND BENEFITS
• We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.