Executive Director, Analytical Development & QC (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

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