Description

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 Responsibilities Bioanalytical Assay Development & Execution<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Design, develop, optimize, and execute PK, ADA, and related ligand-binding assays (e.g., ELISA and MSD) to support nonclinical and clinical studies</li><li style="margin-bottom:11px;">Perform routine and non-routine bioanalytical sample analysis for toxicology and clinical trial samples in accordance with approved protocols and SOPs</li><li style="margin-bottom:11px;">Ensure robust assay performance, including sensitivity, specificity, accuracy, precision, and stability</li></ul>Assay Validation & Technology Transfer<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Lead or support method qualification, validation, and partial validation in compliance with GLP</li><li style="margin-bottom:11px;">Author, review, and maintain bioanalytical validation plans, reports, and SOPs</li><li style="margin-bottom:11px;">Support technology transfer and method bridging to CROs or internal laboratories, including troubleshooting and performance assessment</li></ul>GLP, ICH & Regulatory Compliance<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Conduct all laboratory activities in compliance with GLP, ICH M10, ICH E6, FDA Bioanalytical Method Validation Guidance, and internal quality systems</li><li style="margin-bottom:11px;">Maintain audit-ready documentation, ensuring data integrity, traceability, and compliance</li><li style="margin-bottom:11px;">Support internal QA audits, external audits, and regulatory inspections (e.g., FDA, EMA, NMPA)</li><li style="margin-bottom:11px;">Contribute to IND, CTA, and other regulatory submission documents related to bioanalysis and clinical pharmacology</li></ul>Translational & Cross-Functional Collaboration<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Collaborate with Translational Science, DMPK, Toxicology, Clinical Operations, and Regulatory Affairs teams to align bioanalytical strategy with clinical objectives</li><li style="margin-bottom:11px;">Support exposure–response and PK/PD interpretation, and participate in translational data review meetings</li><li style="margin-bottom:11px;">Provide bioanalytical input into clinical protocols, sample handling plans, and bioanalytical strategy documents</li></ul>Laboratory Operations & Data Integrity<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Manage samples, reagents, and inventory using LIMS systems, ensuring proper chain-of-custody and documentation</li><li style="margin-bottom:11px;">Maintain complete and accurate laboratory notebooks, data records, and analytical reports</li><li style="margin-bottom:11px;">Troubleshoot assay issues and drive continuous improvement initiatives</li></ul>Scientific Growth & Leadership (Senior Scientist level)<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Mentor junior scientists and contribute to team capability development</li><li style="margin-bottom:11px;">Stay current with emerging bioanalytical technologies, regulatory updates, and industry best practices</li><li style="margin-bottom:11px;">Contribute to internal scientific reports, white papers, publications, or conference presentations as appropriate</li></ul> Required Qualifications<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">PhD in Pharmaceutical Sciences, Bioanalytical Chemistry, Biotechnology, Pharmacology, or a related discipline (MS with strong relevant industry experience may be considered)</li><li style="margin-bottom:11px;">2+ years (Scientist) or 5+ years (Senior Scientist) of industry experience in bioanalytical PK and/or ADA assays</li><li style="margin-bottom:11px;">Hands-on experience with ELISA, MSD, and ligand-binding assay platforms</li><li style="margin-bottom:11px;">Strong working knowledge of GLP, ICH guidelines, and global bioanalytical regulatory expectations</li><li style="margin-bottom:11px;">Experience supporting nonclinical and/or clinical studies</li><li style="margin-bottom:11px;">Familiarity with LIMS, data integrity principles, and audit readiness</li><li style="margin-bottom:11px;">Strong analytical, documentation, and problem-solving skills</li><li style="margin-bottom:11px;">Excellent communication skills and ability to work effectively in cross-functional teams</li></ul>Preferred Qualifications<ul style="margin-bottom:11px;"><li style="margin-bottom:11px;">Experience in oncology drug development, including biologics and/or ADCs</li><li style="margin-bottom:11px;">Exposure to clinical pharmacology or PK/PD analysis</li><li style="margin-bottom:11px;">Prior experience collaborating with CRO bioanalytical laboratories</li></ul> Compensation 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.

Scientist/Senior Scientist – Translational Bioanalytical Sciences

Description

SystImmune