Associate Director, Analytical Development / Quality Control

Azalea Therapeutics, Inc.•Berkeley, CA

3h•$170,000 - $210,000•Hybrid

About The Position

Azalea is seeking a scientifically rigorous and execution-oriented Associate Director, Analytical Development / Quality Control to own the external analytical and quality-control capabilities required to advance the pipeline toward first-in-human readiness and support the company’s future pipeline. Reporting to the VP, External CMC Operations, the immediate focus for this role will be establishing phase-appropriate analytical strategies and ensuring assay, testing, release, stability, and external laboratory readiness for planned EDV and AAV manufacturing activities. This is a highly external-facing technical and program leadership role that will work side by side with the internal analytical development team. This leader will ensure that external CRO and CDMO activities are planned, governed, reviewed and delivered on schedule and within compliance of all regulatory requirements for early phase clinical trials. They will bridge internal assay development with external transfer and execution. They will drive method implementation and phase appropriate qualifications, critically reviewing all development reports and data packages. This role is aligned with Azalea’s Associate Director level and will lead a significant functional area with accountability for outcomes. The Associate Director shall combine deep analytical judgement with exceptional vendor management and operational discipline. They will shape analytical plans and priorities, manage ambiguity, influence cross-functional decisions, guide internal contributors and external partners, and connect execution to company goals. The role may directly manage employees as the function grows and is expected to deliver through a combination of internal expertise, consultants, contract laboratories, and CDMO teams. The ideal candidate is a hands-on analytical leader who can establish strategy while also reviewing data, troubleshooting methods, strengthening external execution, and building practical systems. The successful candidate will identify risks early, maintain a clear view of assay readiness across programs and manage outsourced testing that supports process development, lot release, stability, comparability and regulatory filings. This person should be able to balance scientific rigor, GMP expectations, speed, resource constraints, and the need for decision-quality data in an early-stage biotechnology company. This is a hybrid role, onsite 3-5 days in our Berkeley, CA office, depending on project needs. In addition, this role is expected to travel to CRO/CDMO’s as needed during tech transfer and GMP operations.

Requirements

Bachelor’s degree in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences, biotechnology, or a related discipline with 10+ years of relevant experience; Master’s degree with 8+ years; or PhD with 6+ years. Equivalent combinations of education and experience will be considered.
Significant experience in analytical development and/or Quality Control for viral vectors, gene therapies, cell therapies, vaccines, or complex biologics. Direct experience supporting viral vector products is strongly preferred.
Demonstrated experience leading analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management in a regulated development environment.
Experience establishing analytical control strategies, specifications, release-testing plans, stability programs, and phase-appropriate method requirements for clinical-stage products.
Experience providing technical oversight of external laboratories, CDMOs, CROs, or consultants, including data review, timeline management, issue escalation, and performance accountability.
Working knowledge of GMP requirements, data integrity, laboratory investigations, out-of-specification and out-of-trend processes, corrective and preventive actions, change control, and relevant ICH and regulatory expectations.
Familiarity with relevant regulatory and quality expectations, including ICH Q2 (R2(, ICH Q14, FDA/EMA guidance, and phase-appropriate CMC practices.
Experience contributing analytical and QC content to CMC plans, IND-enabling packages, regulatory submissions, or health-authority interactions.
Demonstrated ability to lead significant cross-functional workstreams, manage competing priorities, make sound recommendations with limited direction, and communicate risks and tradeoffs clearly.
Experience guiding, coaching, or managing employees, technical contributors, vendors, or matrixed project teams.
Prior people-management experience.

Nice To Haves

PhD or M.S. in analytical chemistry, biochemistry, molecular biology, chemical engineering, pharmaceutical sciences or related scientific discipline with >10 years of relevant experience.
Experience with AAV, lentiviral vectors, enveloped viral vectors, engineered delivery vehicles, or other advanced gene-delivery modalities.
Technical depth across viral vector analytical methods such as qPCR or ddPCR, infectivity or transduction assays, cell-based potency assays, ELISA, HPLC or UPLC, capillary electrophoresis, residual assays, particle characterization, and compendial testing.
Experience developing potency strategies and establishing links among mechanisms of action, product quality attributes, process performance, and clinical relevance.
Experience supporting method comparability, reference-standard qualification, critical-reagent control, analytical bridging, and stability-indicating method development.
Experience building AD/QC capability in an early-stage biotechnology company with a heavily outsourced operating model.
Experience supporting pre-IND or IND submissions and agency interactions for cell or gene therapy products.
Experience using statistical tools for assay performance evaluation, method validation, trending, and specification development.

Responsibilities

Own the integrated external analytical plan across Azalea programs, including assay scope, development, documentation review and qualification timelines, as well as managing the budget, capacity dependencies, and risk mitigation, with immediate focus on EDV and AAV viral vector manufacturing.
Serve as Azalea’s primary external technical lead and manage day-to-day operations for analytical CROs, CDMOs, and specialty testing laboratories.
Work collaboratively with the internal analytical development team to establish the appropriate analytical assay matrix and method-lifecycle plan needed to support process development, characterization, comparability, release, stability, and regulatory submissions.
Partner with Quality, Regulatory, Process Development, and MSAT colleagues to establish phase-appropriate specifications, acceptance criteria, control strategies, and data packages that support program decisions and product disposition.
Lead regular partner meetings; track actions, milestones, decisions, risks, and deviations from the plan.
Model Azalea’s operating principles by owning outcomes, creating clarity in ambiguity, communicating tradeoffs directly, partnering across functions, and maintaining high standards with low ego.
Coordinate closely with Azalea’s internal analytical development team so that methods, reagents, controls, reference standards, and technical knowledge are ready for transfer.
Oversee critical reagents, reference standards, sample management, method bridging, method comparability, assay controls, data integrity, and other infrastructure required for reliable analytical execution.
Review and provide technically rigorous feedback on external analytical development plans, protocols, method transfer packages, qualification/validation protocols and reports, raw data summaries, certificates of analysis etc..
As part of our quality management system, review and trend analytical and QC data as recommended by the appropriate regulatory guidelines for GMP or internal quality system procedures.
Manage, coach, and develop internal contributors as applicable; provide clear expectations and feedback; and strengthen the performance of external technical teams.
Lead technical review and approval of sampling plans for process development, characterization, engineering, GMP manufacturing, release, stability, comparability and other investigational studies
Coordinate external testing logistics from sample-generation planning through shipping, laboratory receipt confirmation, testing initiation, data turnaround, and final data-package delivery.
Contribute analytical sections to regulatory submissions, briefing materials, CMC development reports, and technical risk assessments.
Serve as the external analytical subject-matter expert on cross-functional CMC teams and present clear, decision-oriented updates to senior stakeholders