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Executive Director Analytical Development Cmc Jobs

$224K - $310K/yr

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 ...

Join us as a Director, Analytical Development , and you'll be part of a culture that welcomes ... Prior experience in analytical CMC and demonstrated management of a multidisciplinary technical ...

Join us as a Director, Analytical Development , and you'll be part of a culture that welcomes ... Prior experience in analytical CMC and demonstrated management of a multidisciplinary technical ...

Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and ... Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to ...

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Executive Director Analytical Development Cmc information

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$89K

$191.4K

$287.5K

How much do executive director analytical development cmc jobs pay per year?

As of Sep 13, 2026, the average yearly pay for executive director analytical development cmc in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

What does an executive director analytical development CMC do?

An Executive Director of Analytical Development CMC (Chemistry, Manufacturing, and Controls) is responsible for overseeing the development, validation, and implementation of analytical methods used to support drug development and manufacturing. They lead teams that ensure the quality and regulatory compliance of analytical testing for pharmaceutical products, manage analytical strategies, and collaborate cross-functionally with research, manufacturing, and regulatory departments. Their role is crucial in ensuring that products meet safety, efficacy, and quality standards throughout the drug lifecycle.

What are some typical challenges faced by an executive director analytical development CMC in managing cross-functional teams?

As an Executive Director of Analytical Development CMC, you will often coordinate multidisciplinary teams across R&D, quality, and manufacturing functions. A common challenge is ensuring clear communication and alignment of project goals, especially when balancing regulatory requirements with tight timelines. You may also need to address resource constraints and shifting priorities as projects advance through different development stages. Building strong relationships and fostering collaboration with stakeholders in various departments is key to overcoming these challenges and driving successful outcomes.

What are the key skills and qualifications needed to thrive as an executive director analytical development CMC, and why are they important?

To thrive as an Executive Director Analytical Development CMC, you need advanced expertise in analytical chemistry, regulatory guidelines, and CMC processes, usually supported by a Ph.D. in a relevant field and extensive industry experience. Familiarity with analytical instrumentation, LIMS, ICH guidelines, and regulatory submission systems is essential. Strategic leadership, effective communication, and cross-functional collaboration are vital soft skills for success in this executive role. These skills and qualifications are crucial to ensure robust analytical strategies, regulatory compliance, and the successful development and commercialization of pharmaceutical products.

What is the difference between Executive Director Analytical Development Cmc vs Analytical Development Manager?

AspectExecutive Director Analytical Development CmcAnalytical Development Manager
ResponsibilitiesOversees global analytical development strategies, leads cross-functional teams, and sets long-term goalsManages daily analytical development activities, supervises team members, and ensures project milestones
Experience & CredentialsExtensive industry experience, advanced degrees, leadership skills, and strategic planning expertiseRelevant scientific background, project management skills, and several years of analytical development experience
Work EnvironmentExecutive-level, strategic planning, cross-departmental collaborationOperational, team management, laboratory-focused

The Executive Director Analytical Development Cmc holds a senior leadership role with strategic responsibilities, while the Analytical Development Manager focuses on day-to-day project execution and team supervision. Both roles require strong scientific credentials, but the director position emphasizes strategic oversight and industry-wide impact.

What are popular job titles related to Executive Director Analytical Development Cmc jobs?

For Executive Director Analytical Development Cmc jobs, the most frequently searched job titles are:

Infographic showing various Executive Director Analytical Development Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, and 3% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $191,412 per year, or $92 per hour.

Senior / Executive Director, Analytical Development CMC

On-site, Remote

$224K - $310K/yr

Full-time

Medical, Life, Retirement, PTO

Posted 17 days ago


Job description

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.
  • 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 IAMBIC THERAPEUTICS
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 iambic.ai.
MISSION & CORE VALUES
Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics 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.