Director, Analytical Development/QC

AVENZO THERAPEUTICS INC•San Diego, CA

5h•$218,000 - $233,000•Hybrid

About The Position

Avenzo Therapeutics, Inc. (“Avenzo” or “Company”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California. 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, including method development and validation, specifications, release and stability testing, impurity control, and regulatory CMC documentation for drug substance and drug product. This hands‑on leader will operate effectively in a lean environment and oversee outsourced analytical activities with strong technical judgment.

Requirements

Bachelor’s degree in chemistry, pharmaceutical sciences, biology, engineering required, or a related area degree preferred (e.g., MS or PhD) with 10+ years of progressive QC, QA oversight of QC, and/or analytical sciences experience in the life sciences industry or an equivalent combination of academic and industry experience
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, with strong scientific judgment
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 the ability to manage multiple projects with competing timelines
Ability to work effectively in cross-functional teams and independently in a remote setting as needed
Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
Strong analytical and problem-solving abilities, with a strategic mindset

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 ensure robust, compliant method across testing sites. Review validation strategies, acceptance criteria, and method trends to ensure methods are robust, controlled, and compliant across testing sites
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, trending, and have 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, and ensuring consistent execution across internal and external labs
Oversee the global stability program, specifications, CoA and QC inputs to annual product reviews, alignment to regulatory filings including protocol input and approval, execution, data review, trend analysis, and reporting to support filings, shelf life, and ongoing product verification
Oversee annual product quality reviews related to QC data, including OOS/OOT trends, stability, CoAs, and release testing
Ensure effective CoA generation, review, and approval for clinical and commercial materials, with strong data integrity, specification compliance, and alignment to regulatory filings
Oversee specification development, approval, and lifecycle management for drug substance, drug product, and combination devices, ensuring scientific justification, phase-appropriate criteria, and alignment with regulatory commitments
Support regulatory submissions, audits, and inspections as a QC 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