Director, Bioanalytical Labs for Biologics & ADCs

SystImmune, Inc.; Bothell (WA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

PTO 15 days

Sick leave

11 holidays

Job summary

SystImmune, Inc. in Bothell, WA, seeks an experienced Associate Director/Director of Bioanalytical Laboratories to lead bioanalytical capabilities across preclinical and clinical programs in biologics and ADCs. This hands-on role combines science with strategy and mentorship.

You will build a high-performing team, oversee PK/ADA/biomarker assay development and regulatory interactions, ensure GLP/GCP compliance, and partner with cross-functional groups to advance oncology programs.

Qualifications

• Ph.D. in Pharmacology, Biochemistry, Analytical Chemistry, Immunology, or 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 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 a plus.

Responsibilities

• 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.
• 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.
• 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.

Skills

Leadership

People management

Communication

Education

Ph.D. in Pharmacology/Biochemistry/Analytical Chemistry/Immunology or related

Job description

SystImmune, Inc. in Bothell, WA, seeks an experienced Associate Director/Director of Bioanalytical Laboratories to lead bioanalytical capabilities across preclinical and clinical programs in biologics and ADCs. This hands-on role combines science with strategy and mentorship.

You will build a high-performing team, oversee PK/ADA/biomarker assay development and regulatory interactions, ensure GLP/GCP compliance, and partner with cross-functional groups to advance oncology programs.