Associate Director/Director, Bioanalytical Laboratory

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 is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, 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). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

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 Bothell, 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 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 a 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 exceeds the requirements of the role.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

• 100% paid employee premiums for medical/dental/vision
• STD
• LTD
• a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
• 15 PTO days per year
• sick leave
• plus 11 paid holidays and MORE

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.