Associate Director - Microbiology

Sarmal, Inc. is an innovative biotech company based in San Diego, California developing revolutionary genomics platforms that aim to transform genetic testing and sequencing. We are seeking a Associate Director of Microbiology to build and lead the microbiology function supporting our target detection platform. This is a leadership role responsible for owning microbiology strategy across assay development, sample preparation, and verification/validation (V&V), and for building the team and infrastructure that scale that work from R&D through commercialization. The ideal candidate is an experienced microbiology leader from a biotechnology, molecular diagnostics, or regulated laboratory environment who pairs deep technical expertise with a track record of building teams and driving cross‑functional programs in a fast‑paced R&D setting. Because this is a newly established function, the right person is energized by rolling up their sleeves to do the work today and building the team that will own it tomorrow. Key Responsibilities Own and lead the microbiology function, defining the strategy and roadmap for all microbiological inputs to the R&D pipeline from concept through feasibility, verification, and validation. Direct planning, prioritization, and execution of microbiology work across multiple concurrent programs, balancing timelines, resources, and quality. Establish the laboratory's microbial strain strategy — sourcing, characterization, banking, inventory governance, and documentation for bacterial and fungal organisms, including clinically relevant pathogens. Set standards for and oversee aerobic and anaerobic culturing, microbial sample preparation, and genomic DNA extraction workflows performed under BSL‑2 conditions. Oversee generation of contrived and mock clinical samples, microbial panels, dilution series, and mixed‑organism samples used for assay development, subsystem testing, and V&V. Team Building & Management Build the microbiology team from the ground up: define the team structure, write the roles, and hire your first microbiologists and research associates. In the interim, personally execute the microbiology workload — bench and documentation alike — until the team is in place to take it on. Set goals, allocate work, develop talent, and establish performance standards and operating cadence for a growing laboratory. Foster a culture of scientific rigor, biosafety, and quality, and mentor staff in microbial handling and documentation best practices. Partner with other R&D functions (engineering, assay development, integration) to direct development of sample preparation methodologies, control selection and design, and transition of assay chemistry from the R&D bench to high‑volume cGMP production. Lead the design of verification and validation studies, in concert with Regulatory Affairs and Assay Development, that meet global regulatory requirements including FDA and European IVDR. Direct the microbial genomic DNA characterization strategy supporting oligonucleotide screening, assay development, and verification studies. Drive the design, development, and scaling of an innovative molecular assay platform, bridging early‑stage process development through commercial manufacturing and ensuring diagnostic kits are scalable, robust, and regulatory‑compliant. Quality, Documentation & Regulatory Establish and own microbiology workflows and SOPs, and ensure traceability and data integrity across microbial samples and study materials. Partner with Clinical, Quality, and Regulatory representatives to deliver documentation packages, study records, and sample traceability that meet quality‑system requirements. Ensure compliance with biosafety procedures, laboratory standards, ISO 13485, and Design Controls. Drive continuous improvement of microbiology workflows, laboratory organization, and documentation practices. Cross‑Functional Collaboration Serve as the microbiology leader across the development organization, representing the function in technical investigations and development milestones. Coordinate microbial sample generation and study support across multiple concurrent projects. Build the scalable microbiology workflows and infrastructure needed to support future clinical and regulatory activities. Qualifications Required MS or PhD in Microbiology, Molecular Biology, Biomedical Sciences, or a related biological sciences discipline. 10+ years in molecular diagnostics, biotechnology, or clinical laboratory environments, with progressive leadership responsibility. Demonstrated experience building and/or managing scientific teams. 8+ years of assay development experience within a commercial biotechnology or medical device company. Proven track record navigating FDA approvals (510(k)/De Novo), IVDR compliance, and/or managing CAP/CLIA‑certified laboratories. Working knowledge of ISO 13485 quality management systems and Design Controls for medical devices. Deep hands‑on expertise in aerobic and anaerobic culturing of bacterial and fungal organisms, including clinically relevant pathogens. Hands‑on expertise with microbial genomic DNA extraction, quantification, and quality assessment. Experience working in BSL‑2 laboratory environments and handling potentially infectious materials. Strong documentation skills, including authoring SOPs, protocols, and study records. Experience with PCR, qPCR, sequencing, or related molecular characterization methods. Strong organizational, written, and verbal communication skills, with attention to detail and scientific rigor. Preferred Experience handling human blood samples or contrived clinical specimens. Experience with laboratory automation platforms. Experience supporting molecular diagnostic, sequencing, or infectious disease product development. Experience supporting analytical studies or V&V activities in a regulated environment. Education & Industry Experience Requirements MS or PhD in Microbiology, Molecular Biology, Biomedical Sciences, or a related biological sciences discipline. 10+ years of hands‑on microbiology experience in biotechnology, molecular diagnostics, clinical laboratory, or related environments. Benefits Medical, dental, and vision coverage Company‑paid life insurance Generous paid time off Access to additional voluntary benefits, employee perks, and discount programs We are committed to supporting the well‑being of our employees and providing a strong foundation for both professional and personal success. The anticipated salary range for this position is $165,000 – $205,000, depending on experience and qualifications. Final compensation will be determined based on a variety of factors including, but not limited to, location, relevant experience, skill set, and internal equity considerations. EEO Statement Sarmal is an equal opportunity employer committed to building a diverse and inclusive workplace. We do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, medical condition, genetic information, marital status, veteran status, or any other characteristic protected by applicable federal, state, or local laws. Reasonable Accommodation Statement Sarmal is an equal opportunity employer that values diversity and inclusion. We welcome applicants of all backgrounds and consider all qualified candidates in accordance with applicable laws. Closing Statement Join us in advancing the next generation of genomic technologies and shaping the future of precision health. #J-18808-Ljbffr Sarmal