Senior Director, Analytical Development CMC

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $224k - $310k / year

⏰ Full Time

🟠 Senior

👔 Director

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series B on 2024-04

Healthcare • Consulting • Manufacturing

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• Lead analytical development and QC functions within CMC • Provide scientific, strategic, and operational oversight across Iambic’s small-molecule portfolio from early clinical development through late-stage development and commercialization • Lead phase-appropriate analytical strategies for drug substance and drug product • Oversee analytical method development, transfer, validation, specifications, impurity control, stability, reference standards, product characterization, and release testing • Serve as primary Analytical Development/QC lead for internal cross-functional teams and external CDMOs/testing labs • Lead DS and DP analytical strategy and scientific oversight across characterization, impurity and degradation-product control, reference standards, comparability, and stability • Assess shelf-life/retest periods and emerging stability risks • Oversee QC release and stability testing, OOS/OOT investigations, deviations, root-cause assessments, CAPAs, and analytical issue resolution • Establish scientifically justified specifications and analytical acceptance criteria • Lead dissolution and product-performance testing, including QC and discriminatory methods for oral drug products • Lead outsourced analytical and QC network partner selection, technical oversight, governance, issue resolution, and performance management • Partner with Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other cross-functional teams to support timelines and manufacturing readiness • Lead analytical CMC support for global regulatory submissions and health authority interactions • Author and review Module 3 content, specifications and justifications, analytical methods, stability sections, and regulatory-query responses • Recruit, lead, coach, and develop team members • Oversee functional resource planning and budget proposals • Foster a collaborative, high-performing environment aligned with organizational goals

🎯 Requirements

• 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 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 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 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 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 • Must be currently 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 • Easy access to great places to live and play