SystImmune · 2 hours ago
Scientist/Senior Scientist – Translational Bioanalytical Sciences
Redmond, WA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $130K/yr
2+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. They are seeking a Scientist or Senior Scientist to support bioanalytical PK, ADA, and related biomarker assays for clinical-stage oncology programs, ensuring compliance with regulatory requirements and contributing to the development of high-quality bioanalytical data.
BiopharmaBiotechnologyProfessional Services
Responsibilities
Design, develop, optimize, and execute PK, ADA, and related ligand-binding assays (e.g., ELISA and MSD) to support nonclinical and clinical studies
Perform routine and non-routine bioanalytical sample analysis for toxicology and clinical trial samples in accordance with approved protocols and SOPs
Ensure robust assay performance, including sensitivity, specificity, accuracy, precision, and stability
Lead or support method qualification, validation, and partial validation in compliance with GLP
Author, review, and maintain bioanalytical validation plans, reports, and SOPs
Support technology transfer and method bridging to CROs or internal laboratories, including troubleshooting and performance assessment
Conduct all laboratory activities in compliance with GLP, ICH M10, ICH E6, FDA Bioanalytical Method Validation Guidance, and internal quality systems
Maintain audit-ready documentation, ensuring data integrity, traceability, and compliance
Support internal QA audits, external audits, and regulatory inspections (e.g., FDA, EMA, NMPA)
Contribute to IND, CTA, and other regulatory submission documents related to bioanalysis and clinical pharmacology
Collaborate with Translational Science, DMPK, Toxicology, Clinical Operations, and Regulatory Affairs teams to align bioanalytical strategy with clinical objectives
Support exposure–response and PK/PD interpretation, and participate in translational data review meetings
Provide bioanalytical input into clinical protocols, sample handling plans, and bioanalytical strategy documents
Manage samples, reagents, and inventory using LIMS systems, ensuring proper chain-of-custody and documentation
Maintain complete and accurate laboratory notebooks, data records, and analytical reports
Troubleshoot assay issues and drive continuous improvement initiatives
Mentor junior scientists and contribute to team capability development
Stay current with emerging bioanalytical technologies, regulatory updates, and industry best practices
Contribute to internal scientific reports, white papers, publications, or conference presentations as appropriate
Qualification
Required
PhD in Pharmaceutical Sciences, Bioanalytical Chemistry, Biotechnology, Pharmacology, or a related discipline (MS with strong relevant industry experience may be considered)
2+ years (Scientist) or 5+ years (Senior Scientist) of industry experience in bioanalytical PK and/or ADA assays
Hands-on experience with ELISA, MSD, and ligand-binding assay platforms
Strong working knowledge of GLP, ICH guidelines, and global bioanalytical regulatory expectations
Experience supporting nonclinical and/or clinical studies
Familiarity with LIMS, data integrity principles, and audit readiness
Strong analytical, documentation, and problem-solving skills
Excellent communication skills and ability to work effectively in cross-functional teams
Preferred
Experience in oncology drug development, including biologics and/or ADCs
Exposure to clinical pharmacology or PK/PD analysis
Prior experience collaborating with CRO bioanalytical laboratories
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
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
11 paid holidays
Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2023 (1)
2022 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
Recent News
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