Scientist / Senior Scientist - Translational Bioanalytical Sciences (PK/ADA)

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). 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. We are seeking a Scientist or Senior Scientist to join our Translational Science/Bioanalysis Department, supporting bioanalytical PK, ADA, and related biomarker assays for clinical-stage oncology programs using ELISA (SoftMax Pro) and MSD platforms.This role serves as a critical translational interface between nonclinical development and clinical trials, generating high-quality, GLP-compliant bioanalytical data to support IND-enabling studies and clinical development (Phase I–III).The successful candidate will be responsible for PK and ADA assay development, validation, and execution, while ensuring full compliance with GLP, ICH, FDA, and global regulatory requirements.Key ResponsibilitiesBioanalytical Assay Development & ExecutionDesign, develop, optimize, and execute PK, ADA, and related ligand-binding assays (e.g., ELISA and MSD) to support nonclinical and clinical studiesPerform routine and non-routine bioanalytical sample analysis for toxicology and clinical trial samples in accordance with approved protocols and SOPsEnsure robust assay performance, including sensitivity, specificity, accuracy, precision, and stabilityAssay Validation & Technology TransferLead or support method qualification, validation, and partial validation in compliance with GLPAuthor, review, and maintain bioanalytical validation plans, reports, and SOPsSupport technology transfer and method bridging to CROs or internal laboratories, including troubleshooting and performance assessmentGLP, ICH & Regulatory ComplianceConduct all laboratory activities in compliance with GLP, ICH M10, ICH E6, FDA Bioanalytical Method Validation Guidance, and internal quality systemsMaintain audit-ready documentation, ensuring data integrity, traceability, and complianceSupport 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 pharmacologyTranslational & Cross-Functional CollaborationCollaborate with Translational Science, DMPK, Toxicology, Clinical Operations, and Regulatory Affairs teams to align bioanalytical strategy with clinical objectivesSupport exposure–response and PK/PD interpretation, and participate in translational data review meetingsProvide bioanalytical input into clinical protocols, sample handling plans, and bioanalytical strategy documentsLaboratory Operations & Data IntegrityManage samples, reagents, and inventory using LIMS systems, ensuring proper chain-of-custody and documentationMaintain complete and accurate laboratory notebooks, data records, and analytical reportsTroubleshoot assay issues and drive continuous improvement initiativesScientific Growth & Leadership (Senior Scientist level)Mentor junior scientists and contribute to team capability developmentStay current with emerging bioanalytical technologies, regulatory updates, and industry best practicesContribute to internal scientific reports, white papers, publications, or conference presentations as appropriateRequired QualificationsPhD 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 assaysHands-on experience with ELISA, MSD, and ligand-binding assay platformsStrong working knowledge of GLP, ICH guidelines, and global bioanalytical regulatory expectationsExperience supporting nonclinical and/or clinical studiesFamiliarity with LIMS, data integrity principles, and audit readinessStrong analytical, documentation, and problem-solving skillsExcellent communication skills and ability to work effectively in cross-functional teamsPreferred QualificationsExperience in oncology drug development, including biologics and/or ADCsExposure to clinical pharmacology or PK/PD analysisPrior experience collaborating with CRO bioanalytical laboratoriesCompensation and Benefits:The expected base salary range for this position is $90,000 - $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, level of position, 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. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.  SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply. Powered by JazzHRBAXsujXFcE

Salary : $90,000 - $130,000