Reseach Associate, Clinic Pathology and CDx (IHC Focus)
SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. 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 several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
Job
Summary:
Systimmnue's Clinic Pathology and Companion Diagnostics Business (CDx) to develop, manufacture and commercialize in vitro diagnostic devices, which are a critical part of precision medicine. We are looking for a talented and dedicated Research Associate to join our Clinic Pathology, CDx Research and Development team. You will involve the clinical requirements for new diagnostic products, conducting the clinical biomarker and validation to register these products as In Vitro Diagnostics with regulatory agencies, drive medical value innovation and clinical differentiation of key products. You join our Clinic Pathology and CDx team, focusing on patient sample analysis using immunohistochemistry (IHC) techniques. The successful candidate will be responsible for conducting experiments, analyzing data, and contributing to the overall success of our clinical trial programs. This position requires expertise in IHC methodologies, as well as experience working in CLIA-certified laboratory environments. You will work in across-functional team dedicated to the design and development of CDx assays in a highly regulated environment. This position based on Redmond WA with onsite work locations.
Key
Responsibilities:
Perform immunohistochemistry experiments on patient samples collected from clinical trials according to established protocols and standard operating procedures (SOPs).
Conduct data analysis and interpretation, including quantification of IHC staining and correlation with clinical outcomes.
Maintain accurate records of experimental procedures, results, and data analysis in compliance with regulatory requirements.
Collaborate with cross-functional teams, including research, clinical development, biostatistics, and regulatory affairs, to define biomarker strategies and integrate companion diagnostics into clinical trial protocols.
Conducting and validating analytical performance characteristics of IHC assays, including sensitivity, specificity, reproducibility, and robustness, in accordance with regulatory guidelines (FDA, EMA).
Generate technical documentation, including assay protocols, validation reports, and regulatory submissions, to support companion diagnostic development and regulatory approval.
Implement quality control procedures and participate in laboratory inspections and audits to ensure compliance with regulatory standards (ISO 13485, CLIA and CAP).
Qualifications:
B.S. in Biological Sciences, Immunology, Pathology or related field with a minimum of 3 years of relevant experience in clinical research or diagnostic laboratory settings.
Demonstrated expertise in immunohistochemistry techniques, including tissue processing, antigen retrieval, antibody staining, and imaging analysis.
Experience working in CLIA-certified laboratories and familiarity with CLIA regulations and quality control standards.
Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
Prior experience with biomarker discovery or companion diagnostics development is desirable.
Passionate about working at the intersection of digital pathology and AI. The ideal candidate will have a strong interest in leveraging cutting-edge technology to revolutionize pathology practices and contribute to the advancement of healthcare. Experience or knowledge in digital pathology, image analysis, machine learning, and related fields is highly desirable.
The hiring pay range for this position is $70,000 - $110,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a stable, 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.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to email protected Estimated Salary: $20 to $28 per hour based on qualifications.
Job
Summary:
Systimmnue's Clinic Pathology and Companion Diagnostics Business (CDx) to develop, manufacture and commercialize in vitro diagnostic devices, which are a critical part of precision medicine. We are looking for a talented and dedicated Research Associate to join our Clinic Pathology, CDx Research and Development team. You will involve the clinical requirements for new diagnostic products, conducting the clinical biomarker and validation to register these products as In Vitro Diagnostics with regulatory agencies, drive medical value innovation and clinical differentiation of key products. You join our Clinic Pathology and CDx team, focusing on patient sample analysis using immunohistochemistry (IHC) techniques. The successful candidate will be responsible for conducting experiments, analyzing data, and contributing to the overall success of our clinical trial programs. This position requires expertise in IHC methodologies, as well as experience working in CLIA-certified laboratory environments. You will work in across-functional team dedicated to the design and development of CDx assays in a highly regulated environment. This position based on Redmond WA with onsite work locations.
Key
Responsibilities:
Perform immunohistochemistry experiments on patient samples collected from clinical trials according to established protocols and standard operating procedures (SOPs).
Conduct data analysis and interpretation, including quantification of IHC staining and correlation with clinical outcomes.
Maintain accurate records of experimental procedures, results, and data analysis in compliance with regulatory requirements.
Collaborate with cross-functional teams, including research, clinical development, biostatistics, and regulatory affairs, to define biomarker strategies and integrate companion diagnostics into clinical trial protocols.
Conducting and validating analytical performance characteristics of IHC assays, including sensitivity, specificity, reproducibility, and robustness, in accordance with regulatory guidelines (FDA, EMA).
Generate technical documentation, including assay protocols, validation reports, and regulatory submissions, to support companion diagnostic development and regulatory approval.
Implement quality control procedures and participate in laboratory inspections and audits to ensure compliance with regulatory standards (ISO 13485, CLIA and CAP).
Qualifications:
B.S. in Biological Sciences, Immunology, Pathology or related field with a minimum of 3 years of relevant experience in clinical research or diagnostic laboratory settings.
Demonstrated expertise in immunohistochemistry techniques, including tissue processing, antigen retrieval, antibody staining, and imaging analysis.
Experience working in CLIA-certified laboratories and familiarity with CLIA regulations and quality control standards.
Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
Prior experience with biomarker discovery or companion diagnostics development is desirable.
Passionate about working at the intersection of digital pathology and AI. The ideal candidate will have a strong interest in leveraging cutting-edge technology to revolutionize pathology practices and contribute to the advancement of healthcare. Experience or knowledge in digital pathology, image analysis, machine learning, and related fields is highly desirable.
The hiring pay range for this position is $70,000 - $110,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a stable, 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.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to email protected Estimated Salary: $20 to $28 per hour based on qualifications.
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