Associate Director, Analytical Development Quality Control

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 immunotherapiesin 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 companys 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 Azaleas 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 addition this role is expected to travel to CRO/CDMOs as needed during tech transfer and GMP operations.

Key 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 Azaleas 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 Azaleas 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 Azaleas 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

• Bachelors degree in analytical chemistry biochemistry molecular biology pharmaceutical sciences biotechnology or a related discipline with 10 years of relevant experience; Masters 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 36 months)

• Develops a strong understanding of Azaleas 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 $170000 - $210000 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.

Azaleas 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.

Notice to Recruiters/Staffing Agencies: Recruiters and staffing agencies should not contact Azalea Therapeutics through this page. We require that all Recruitment Vendors (e.g. search firms recruitment agencies and staffing companies) have a fully executed formal written agreement on file with Azalea prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with Azalea and Azalea will not be responsible for any purported fees. For more information please contact our HR team at .

Information on Fraudulent Job Offers:Azalea is aware that some job seekers have received false employment offers or recruitment emails from individuals or organizations posing as Azalea. The individuals or organizations sending these false employment offers may send requests seeking to gain personal information items of value or monetary funds under the premise that doing so is required to further the recruitment process.

Azalea never requests passport details financial information items of value or money from job seekers for any reason as part of the recruitment process. Individuals who receive an offer of employment from Azalea are always required to go through a formal recruitment process which includes an interview with a member of Azaleas Human Resources recruitment team and the hiring manager.

Legitimate email communications from Azalea will also only use emails that end in @ from our core recruitment team. Fraudulent emails claiming to be sent by Azalea or Azalea employees may come from similar sounding emails with endings like @ or @ or even emails ending in common public domain addresses with endings like @ or @. There can also be instances of fraudulent communication that use the names and pictures of known company employees claiming to be sent from those employees or that even link out to fake websites that were created to look and feel like the real company website.

We are taking steps to investigate these fraudulent communications. If you feel that you have been a potential victim of an employment application scam please contact the Internet Crimes Complaint Center at. The Internet Crimes Complaint Center is an FBI entity that aggregates criminal events in order to analyze and prosecute numerous related scams.