Associate Director/Director, Bioanalytical Laboratory

Systimmune•Redmond, WA

3d•$150,000 - $230,000•Onsite

About The Position

SystImmune is seeking an experienced and visionary Associate Director/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 pharmacokinetic (PK) and anti-drug antibody (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 for a leader who thrives at the intersection of science, strategy, and mentorship. The position is full-time onsite and based in Redmond, WA.

Requirements

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.

Nice To Haves

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.
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.
Collaborate closely with Translational Sciences, Clinical Pharmacology, Regulatory Affairs, and Quality to ensure alignment on 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.