Energy Jobline ZR
Director, Bioanalytical Laboratory in Redmond
Energy Jobline ZR, Redmond, Washington, United States, 98052
SystImmune is a leading and well‑funded clinical‑stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi‑specific, multi‑specific antibodies, and antibody‑drug conjugates (ADCs). The company has multiple assets in various stages of clinical trials for solid tumor and hematologic indications and a robust preclinical pipeline of potential cancer therapeutics in the discover and IND‑enabling stages.
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. 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. 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 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. 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. Compensation and Benefits
The expected base salary range for this position is $150,000 – $230,000 annually. Actual compensation will be based on a variety of factors, including, but not limited to, the candidate’s qualifications, experience, and skills. While most offers typically fall within the
low to mid‑point
of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role. SystImmune offers a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, automated STD and LTD plans, a 401(k) plan with a 50% company match up to 3% and a vesting schedule of 5 years, 15 PTO days per year, sick leave, 11 paid holidays, and additional benefits. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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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. 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. 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 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. 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. Compensation and Benefits
The expected base salary range for this position is $150,000 – $230,000 annually. Actual compensation will be based on a variety of factors, including, but not limited to, the candidate’s qualifications, experience, and skills. While most offers typically fall within the
low to mid‑point
of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role. SystImmune offers a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, automated STD and LTD plans, a 401(k) plan with a 50% company match up to 3% and a vesting schedule of 5 years, 15 PTO days per year, sick leave, 11 paid holidays, and additional benefits. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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