Director, Analytical Development/QC

Avenzo Therapeutics, Inc. (“Avenzo”) is a clinical-stage biotechnology company developing next-generation oncology therapies. Co-founded in 2022 by former executives of Turning Point Therapeutics, Avenzo is headquartered in San Diego, California, with a passionate team committed to advancing targeted oncology programs.

About the role

Reporting to the Senior Vice President, CMC, the Director, Analytical Development/Quality Control (QC) will lead analytical strategy and execution across preclinical and clinical programs. This hands-on leader will oversee outsourced analytical activities, ensuring robust, compliant methods and regulatory documentation for drug substance and drug product.

Responsibilities

• Lead analytical development and QC testing for biologics programs from early development through commercialization, primarily through external partners.
• Drive analytical characterization to define molecular behavior, structure-function relationships, and impact on mechanism of action (MOA).
• Author and review analytical sections of CMC filings; communicate risks, timelines, and data interpretation to internal teams and external stakeholders.
• Build and manage Contract Development and Manufacturing Organization (CDMO) and Clinical Trial Liaisons (CTL) partnerships, using metrics to manage risk and drive performance.
• Oversee analytical method development, transfer, validation, verification, and lifecycle management to ensure robust, compliant methods across testing sites.
• Review validation strategies, acceptance criteria, and method trends to maintain method robustness and compliance.
• Provide technical and quality oversight for QC activities, including raw material, in-process, release, stability, and special testing for drug substance and drug product.
• Ensure QC operations comply with global regulations and internal standards; serve as escalation point for critical QC and compliance issues.
• Review and approve investigations (e.g., OOS/OOT, deviations, data integrity), ensuring they are scientifically sound, risk-based, and include effective CAPAs.
• Trend QC events to identify and resolve systemic issues.
• Manage the lifecycle of reference standards and critical reagents, including qualification, potency assignment, and requalification strategies.
• Oversee the global stability program, specifications, CoA, and QC inputs to annual product reviews, including protocol input, execution, data review, and reporting.
• Ensure effective CoA generation, review, and approval for clinical and commercial materials, with strong data integrity and specification compliance.
• Oversee specification development, approval, and lifecycle management for drug substance, drug product, and combination devices.
• Support regulatory submissions, audits, and inspections as a QC Subject Matter Expert (SME).
• Establish QC processes within the QMS (SOPs, training, change control, and risk management).
• Contribute QC metrics, trends, and risk assessments to QMR and Quality Council forums.
• Provide leadership, mentoring, and oversight of QC staff and external partners.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, biology, engineering, or a related field; advanced degree (MS or PhD) preferred.
• 10+ years of progressive QC, QA oversight of QC, and/or analytical sciences experience in the life sciences industry.
• Experience supporting small molecule, biologics, and/or combination device programs.
• Strong knowledge of FDA, EMA, ICH, EU GMP, and global QC regulatory requirements.
• Proven track record supporting regulatory inspections, resolving complex QC compliance issues, and applying risk-based approaches.
• Experience with statistical analysis of analytical data and method capability.
• Deep expertise in analytical data interpretation, method capability, laboratory investigations, and data integrity.
• Ability to apply scientific judgment to data interpretation, method performance issues, and complex laboratory investigations.
• Strong organizational skills and ability to manage multiple projects with competing timelines.
• Ability to work effectively in cross-functional teams and independently in a remote setting.
• Excellent communication and interpersonal skills, with a strategic mindset.

Schedule

• Remote: Home office with periodic travel to San Diego headquarters.
• San Diego-based: On-site requirement (Monday through Thursday).
• Periodic/regular travel, including up to 10% of work time, which may include overnight travel.

Pay

The salary range for this position is $218,000 to $233,000 per year. The final pay offered will depend on factors such as experience, education, and skills.

Benefits

• Medical, dental, vision, and basic life and AD&D insurance for employees and eligible dependents.
• Short-term and long-term disability insurance.
• Flexible spending accounts and health savings accounts.
• Voluntary insurance programs, including voluntary life, AD&D, accident, and critical illness.
• 401(k) plan enrollment.
• 10 hours of paid vacation time accrued monthly.
• 1 hour of paid sick leave accrued for every 30 hours worked.
• 17 paid holidays each calendar year, including a winter closure.

Other Compensation

• Eligibility for an annual discretionary bonus.
• Eligibility for an equity award, subject to applicable plan documents and Company policies.

Physical Demands and Work Environment

• Constant or continuous use of a computer keyboard, monitor, and mouse.
• Constant or frequent sitting, standing, or walking.
• May lift and/or move objects of various weights.
• Moderate noise level in the work environment.
• Fast-paced, time-sensitive environment with frequently changing priorities.
• Ability to handle multiple projects simultaneously.

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.