Senior / Executive Director, Analytical Development CMC

Nexus Venture Partners; San Diego (CA); On-site; USD 224,000 - 310,000; Full time

Benefits offered by this job

Competitive pay

Company-paid healthcare

Flexible Spending Accounts (FSA)

Voluntary life insurance

401K matching

Uncapped vacation

Job summary

Iambic Therapeutics seeks a Senior or Executive Director to lead Analytical Development and QC across its small-molecule portfolio, guiding method development, transfer, validation, and regulatory readiness. This role partners with CDMOs and internal teams to ensure compliant, timely execution of analytics from early clinical to commercialization.

The role emphasizes strategic direction, people leadership, and collaboration with Drug Substance, Drug Product, Quality, Regulatory CMC, and Clinical

Qualifications

• Ph.D. in Analytical Chemistry or related field with 12+ years pharma/biotech experience (or equivalent MS/BS with longer tenure).
• Hands-on experience in analytical method development, transfer, and validation for DS/DP across development stages.
• Experience leading Analytical Development and QC with external CDMOs and partners.
• Deep knowledge of cGMP, ICH guidelines, and regulatory expectations for drug development.

Responsibilities

• Lead DS and DP analytical strategy and scientific oversight across characterization, impurity, and stability.
• Oversee method development, transfer, validation, and lifecycle management.
• Manage QC testing and data review for release and stability, incl. OOS/OOT investigations.
• Set specifications and acceptance criteria based on product understanding and data.
• Provide leadership for dissolution and product-performance testing.
• Direct outsourced analytical and QC network, including vendor governance.
• Ensure activities align with program timelines and manufacturing readiness.
• Support global regulatory submissions and health authority interactions (Module 3 content).
• Recruit and develop team, manage resources and budget.

Skills

Strategic leadership

Analytical development

QC oversight

Cross-functional collaboration

Regulatory readiness

cGMP knowledge

Communication skills

Travel readiness

Education

Ph.D. in Analytical Chemistry

M.Sc. in Analytical Chemistry

B.Sc. in a related field

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.

Location

Remote - US; San Diego HQ

Employment Type

Full time

Location Type

Remote

Department

ClinicalCMC

Compensation

• Senior Director$224K – $280K
• Executive Director$248K – $310K

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.
Compensation Range: $224K - $310K