Senior Director, Analytical Development CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee analytical development and quality control functions within CMC.

• Provide scientific, strategic, and operational oversight for Iambic’s small-molecule portfolio from early clinical development through late-stage development and commercialization.

• Direct phase-appropriate analytical strategies for both drug substance and drug product.

• Manage analytical method development, transfer, validation, specifications, impurity control, stability, reference standards, product characterization, and release testing.

• Act as the primary Analytical Development/QC lead for internal cross-functional teams and external CDMOs/testing laboratories.

• Lead the analytical strategy and scientific oversight for drug substance and drug product, focusing on characterization, impurity and degradation-product control, reference standards, comparability, and stability.

• Evaluate shelf-life/retest periods and identify emerging stability risks.

• Supervise QC release and stability testing, OOS/OOT investigations, deviations, root-cause assessments, CAPAs, and resolution of analytical issues.

• Establish scientifically justified specifications and analytical acceptance criteria.

• Direct dissolution and product-performance testing, including QC and discriminatory methods for oral drug products.

• Lead the selection, technical oversight, governance, issue resolution, and performance management of outsourced analytical and QC network partners.

• Collaborate with Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other cross-functional teams to support timelines and manufacturing readiness.

• Provide analytical CMC support for global regulatory submissions and interactions with health authorities.

• Author and review Module 3 content, specifications and justifications, analytical methods, stability sections, and responses to regulatory queries.

• Recruit, lead, mentor, and develop team members.

• Oversee functional resource planning and budget proposals.

• Promote a collaborative, high-performing environment that aligns with organizational objectives.

⛳️ Requirements

• Ph.D. in Analytical Chemistry or a related discipline with 12+ years of experience in the pharmaceutical/Biotech industry, or an M.Sc. with 14+ years, or a B.Sc. with 17+ years of experience.

• Extensive hands-on experience in analytical method development, transfer, troubleshooting, and validation for small molecule drug substance and drug product throughout early and late-stage development.

• Strong background in 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 as well as regulatory filings, including IND/IMPD, and preferably NDA/MAA.

• Proven track record of leading Analytical Development and QC efforts through external CDMOs, including technical oversight, issue resolution, and management of multiple programs and partners.

• In-depth understanding 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.

• Demonstrated leadership experience in building collaborative, high-performing teams and effectively working across Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other functions.

• Excellent written and verbal communication skills, with the ability to convey technical issues, risks, and recommendations to internal stakeholders, external partners, and health authorities.

• Willingness to travel up to 15% domestically and internationally.

• Must be authorized to work in the United States.

• Must address analytical strategy, a technical or regulatory challenge, and outcome in a 100–250-word application response.

🏝️ Benefits

• Company-paid healthcare.

• Flexible spending accounts.

• Voluntary life insurance.

• 401(k) matching.

• Uncapped vacation.

• Onsite gym.

• Onsite dining.

• Brand-new state-of-the-art facility.

• Convenient access to great places to live and play.