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Systimmune

Director, Bioanalytical Laboratory

Systimmune, Redmond, Washington, United States, 98052

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SystImmune is a leading and well-funded clinical-stage biopharmaceutical company with locations in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using bi-specific, multi-specific antibodies and antibody-drug conjugates (ADCs). The company has assets in various stages of clinical trials for solid tumor and hematologic indications, alongside a robust preclinical pipeline in discovery and IND-enabling stages. We offer an opportunity to learn and grow while making significant contributions to the company's success. SystImmune is seeking an experienced and visionary

Director of Bioanalytical Laboratories

to lead, expand, and inspire our bioanalytical capabilities supporting preclinical and clinical programs in biologics and ADC development. This role combines scientific depth, operational excellence, and people leadership. The Director will oversee assay development, validation, and execution for PK and ADA analyses, supporting ADCs and other biologics, while building a high-performing team and fostering a culture of scientific rigor and continuous learning. This is a hands-on, high-impact role at the intersection of science, strategy, and mentorship. The position is full-time onsite and based in Redmond, WA. Responsibilities

Strategic & Scientific Leadership

Define and execute bioanalytical strategies supporting discovery, preclinical, and clinical development of biologics and ADCs. Lead the design, development, validation, and troubleshooting of PK, ADA, and biomarker assays using ligand-binding, ELISA, ECLIA, LC-MS/MS, and hybrid methods. Serve as the bioanalytical lead in cross-functional project teams and regulatory interactions. Anticipate and adapt to evolving regulatory expectations and scientific advances to ensure SystImmune remains at the forefront of bioanalytical science.

Operational & Laboratory Management

Oversee day-to-day laboratory operations to ensure compliance with GLP, GCP, ICH, and 21 CFR Part 11 standards. Direct equipment qualification, calibration, and maintenance programs. Establish and maintain SOPs, safety protocols, data integrity systems, and quality management processes. Partner with Quality Assurance to prepare for audits and regulatory inspections, maintaining a state of perpetual readiness.

Team Leadership & Talent Development

Build, inspire, and empower a team of exceptional scientists and analysts. Foster a culture that emphasizes mentorship, growth, and scientific curiosity, helping staff expand their technical expertise and leadership potential. Create individualized development plans and cross-training opportunities to strengthen technical depth and career progression. Promote open communication, shared accountability, and recognition of high performance.

Cross-Functional & Global Collaboration

Collaborate with Translational Sciences, Clinical Pharmacology, Regulatory Affairs, and Quality to align analytical strategy and regulatory submissions. Partner with global bioanalytical and translational teams to harmonize methods, data standards, and reporting practices. Represent SystImmune’s bioanalytical expertise in internal governance forums and external scientific networks.

Qualifications

Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, Immunology, or a related discipline (M.S. with significant experience considered). 10+ years of industry experience in bioanalytical sciences supporting biologics or ADC programs, including 5+ years in a leadership role. Demonstrated expertise in assay development, validation, and regulatory submission for PK/ADA/biomarker methods. Proven success managing GLP/GCP-compliant lab operations and preparing for health authority inspections. Strong understanding of global regulatory requirements (FDA, EMA, NMPA, ICH M10, E6). Exceptional leadership and people management skills with a track record of developing scientific talent and fostering high-performance teams. Effective communicator who can translate complex data into strategic decisions. Experience managing CROs or global lab partnerships is a plus. Compensation & Benefits

The expected base salary range for this position is $150,000 - $230,000 annually. Actual compensation will be based on factors including but not limited to qualifications, experience, and skills. Offers may fall toward the higher end for exceptional candidates whose background and expertise align strongly with the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3%, a 5-year vesting schedule, 15 PTO days per year, sick leave, 11 paid holidays, and more. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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