Associate Director, Analytical Development / Quality Control

Socket.dev; Berkeley (CA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Bonus/Equity eligible

Job summary

Azalea Therapeutics in Berkeley, CA is seeking an Associate Director, Analytical Development / Quality Control to own external analytical and QC capabilities for advancing EDV and AAV programs. The role reports to the VP, External CMC Operations in a hybrid onsite setting.

The candidate will establish phase-appropriate analytical strategies, manage CRO/CDMO partnerships, and ensure regulatory compliance for early-phase clinical trials, with emphasis on method transfer and data integrity.

Qualifications

• Bachelor’s degree in analytical chemistry or related field required.
• Experience leading analytical method development and transfer in GMP environment.
• Experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Own the integrated external analytical plan across Azalea programs.
• Lead external CRO/CDMO management and oversight.
• Coordinate method transfer, validation, and lifecycle management.
• Collaborate with Quality, Regulatory, and MSAT to define specifications.
• Review data packages and reports for regulatory readiness.

Skills

Analytical thinking

External collaboration

Cross-functional leadership

Regulatory understanding

Data interpretation

Education

Bachelor’s degree in analytical chemistry / biochemistry / molecular biology / pharmaceutical sciences / biotechnology or related

Master’s degree with 8+ years or PhD with 6+ years

Tools

qPCR

ddPCR

ELISA

HPLC/UPLC

Capillary electrophoresis

Job description

Job Title: Associate Director, Analytical Development / Quality Control

Department: External CMC Operations

Reports to: VP of External CMC Operations

Location: Hybrid Role, Onsite 3-5 days per week in Berkeley, CA

Employment Type: Full-time

FLSA Status: Exempt

Bonus/Equity: Eligible

About Azalea

Azalea Therapeutics is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo. Azalea is pioneering a new way to turn a persons own T cells into a powerful cancer therapy directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles, or EDVs. As highly selective couriers, EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell, the anti-cancer agent is inserted into a precise site in the genome, ensuring safe and potent modifications to fortify the T cells against cancers.

Why this matters:

• We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body.
• Our platform is designed for precision, so the right cells are safely programmed to effectively fight cancer.
• This technology has the potential to treat a wide range of cancers with a streamlined, scalable process.

Our goal is simple:

develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients.

How We Work

Azalea is building ambitious science in a fast-moving environment. The people who thrive here are accountable, adaptable, rigorous, humble, and direct. Across roles and functions, we look for team members who demonstrate the following:

• Outcome Ownership - We own results, close loops, and follow through without needing to be prompted. We take responsibility for moving work forward and making sure important decisions, deliverables, and handoffs do not fall through the cracks.
• Comfort with Ambiguity - We operate in an early-stage environment where information may be incomplete and priorities may evolve. We clarify quickly, make thoughtful decisions with the information available, and adapt without unnecessary drama.
• High Standards, Low Ego - We care deeply about the quality of the work and the impact it can have for patients. We raise the bar while staying humble, direct, and open to feedback.
• Collaboration and Candor - We share context early, communicate clearly, partner across functions, and operate with transparency. We believe strong collaboration requires both trust and direct communication.

The Opportunity

Azalea is seeking a scientifically rigorous and execution orientated 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.

External Analytical Program Leadership

• 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.

Technical Oversight & Data Management

• 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

Qualifications

• Minimum Qualifications
• 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.
• Preferred Qualifications
• 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.

What Success Looks Like (first 3-6 months)

• Develops a strong understanding of Azalea’s platform, AZA-2509 program strategy, EDV and AAV product and process attributes, external testing network, and 2026 company goals.
• Completes a risk‑based AD/QC readiness assessment that identifies method gaps, transfer needs, laboratory capacity risks, documentation needs, and critical decisions for pilot, engineering, and GMP activities.
• Clarifies phase‑appropriate specifications, testing strategies, in‑process controls, release requirements, stability plans, reference standards, and critical reagent needs.
• Ensures analytical readiness supports planned pilot, engineering, and GMP manufacturing execution without avoidable testing or release delays.
• Establishes reliable processes for analytical data review, trending, investigation, decision‑making, and cross‑functional communication.
• Provides credible analytical and QC leadership for CMC planning, regulatory materials, and company‑critical program decisions.
• Builds trusted relationships across Technical Operations, Quality, Regulatory, Research, and external partners and creates clarity about responsibilities and decision rights.

Working Conditions / Physical Requirements (as applicable)

• Ability to work in a hybrid environment with regular engagement with Bay Area‑based colleagues, laboratories, and external partners.
• Ability to travel as needed to CDMOs, contract testing laboratories, manufacturing sites, technical meetings, and company business locations.
• Ability to work in laboratory or manufacturing environments as needed and comply with applicable safety, gowning, and personal protective equipment requirements.
• This role includes substantial computer‑based data review, document preparation, virtual collaboration, and in‑person technical meetings.

Compensation and Benefits

• The expected salary range for this role based on the primary location for this position in California is $170,000 - $210,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job‑related factors permitted by law. Salary will be commensurate with experience, qualifications, training and market.
• This role is eligible for annual performance bonuses, equity grants, and a comprehensive benefits package that includes medical, dental, vision, retirement plan with company match, and paid time off.

Azalea’s Commitments

Equal Employment Opportunity (EEO): Azalea is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable law.

Reasonable Accommodation: We will provide reasonable accommodation to qualified individuals with disabilities and to individuals with sincerely held religious beliefs, consistent with applicable law. To request accommodation, email HR at [HR email].

Applicant Privacy: Azalea collects and uses applicant personal information for recruiting and employment purposes. If applicable, Azalea will provide a California applicant privacy notice describing categories of information collected, purposes, retention, and rights under the California Consumer Privacy Act (CCPA/CPRA).

Job Description Disclaimer: This job description may change at any time based on business needs. It is not a contract and does not create a promise of employment for any particular duration.