Senior Director, Analytical Development & QC, CMC

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

Benefits offered by this job

Industry leading pay

Company-paid healthcare

401K matching

Uncapped vacation

Onsite gym and dining

Job summary

Iambic Therapeutics, a San Diego–based clinical-stage biotech, seeks a Senior or Executive Director to lead Analytical Development and QC across DS and DP for small‑molecule programs. The role provides scientific, strategic, and operational oversight to ensure compliant, timely analytical execution.

You will set phase-appropriate strategies, supervise method development, transfer, validation, specifications and impurity control, and partner with CDMOs and internal teams to enable regulatory

Qualifications

• Ph.D. in Analytical Chemistry or related field with 12+ years in pharma/biotech (or MSc with 14+ years or BSc with 17+ years).
• Hands-on experience in analytical method development, transfer, troubleshooting and validation for DS/DP.
• Experience supporting regulatory filings (IND/IMPD; NDA/MAA preferred).

Responsibilities

• Lead DS/DP analytical strategy across impurity control, reference standards, and stability.
• Oversee analytical method development, transfer, and validation.
• Manage QC testing and data review for release and stability, incl. OOS/OOT investigations.
• Establish specifications and acceptance criteria based on process understanding.
• Lead dissolution and product-performance testing efforts.
• Manage outsourced analytical and QC network (CDMOs).
• Ensure timelines and manufacturability through cross-functional collaboration.
• Contribute to regulatory submissions and health authority interactions.
• Recruit, mentor, and develop team members.

Skills

Analytical leadership

Strategic oversight

Regulatory strategies

CDMO management

Quality control leadership

Team development

Cross-functional collaboration

Strong communication

cGMP knowledge

Problem solving

Risk assessment

Education

Ph.D. in Analytical Chemistry

Experience: 12+ years in pharma/biotech

Tools

Regulatory guidelines knowledge

Job description

Iambic Therapeutics, a San Diego–based clinical-stage biotech, seeks a Senior or Executive Director to lead Analytical Development and QC across DS and DP for small‑molecule programs. The role provides scientific, strategic, and operational oversight to ensure compliant, timely analytical execution.

You will set phase-appropriate strategies, supervise method development, transfer, validation, specifications and impurity control, and partner with CDMOs and internal teams to enable regulatory