Medicines360
Senior or Principal Scientist, Diagnostics Product Development
Medicines360, San Francisco, California, United States, 94199
Salary :
$210,000 to $225,000
Overview Medicines360 is a womens health innovation organization focused on solving consequential issues and transforming novel ideas into life-changing products. We are dedicated to improving womens health worldwide and addressing pressing concerns with our launched products. For more information, visit Medicines360.org.
Position Title Senior or Principal Scientist, Diagnostics Product Development
Reports To TBD
Status Full-time
Location San Francisco Hybrid
Position Summary At Medicines360, we are developing tests for early detection and treatment of maternal health diagnostics to transform care. As a Senior or Principal Scientist, Diagnostics Product Development, you will utilize your knowledge of diagnostic technologies, including proteomics and transcriptomics, to drive the development of a set of biomarker tests for scalable, reproducible analysis of diseases that cause stillbirth. This role will contribute significantly to the scientific and technological direction of the diagnostics that are core to our maternal health development program.
Essential Duties and Responsibilities
Oversees laboratory-based diagnostic science and innovation projects with a focus on proteomics, collaborating with cross-functional teams.
Oversee pivotal clinical program sample collection, testing and documentation to meet regulatory requirements for US FDA approval.
Oversee the identification and development of select antibodies with high specificity and affinity for target proteins, including de-novo antibody development.
Manages the selection process of a CRO for the development of immunoassays.
Oversee the design and development of immunoassays for various biomarkers across diverse biological matrices, ensuring high-quality, reproducible data.
Ability to leverage experience with a range of technology platforms across proteomics and transcriptomics to select optimal platforms.
Work with outside vendors to develop and optimize assay parameters to meet performance requirements, including sensitivity, specificity, dynamic range, precision, and robustness.
Oversee the evaluation and integration of novel technologies, reagents, and workflow improvements to enhance assay performance and scalability for both singleplex and multiplex formats.
Oversee bridging studies and rigorous data analysis using appropriate bioanalytical and statistical tools to determine key assay performance characteristics and support regulatory submissions.
Provide technical expertise to support LDT and IVD submissions to regulating organizations.
Oversee the maintenance of accurate, thorough, and timely research documentation, and provide progress reports regularly.
Work cross-functionally with internal teams and external partners to ensure timely and accurate execution of project deliverables.
Oversee the authoring, maintaining, and review of assay development documentation, including technical reports, SOPs, and work instructions, ensuring traceability and compliance with industry standards.
Essential Skills & Qualifications
Ph.D. in Biochemistry, Molecular Biology, Systems Biology, Biochemical Engineering or a related discipline, with a minimum of 10+ years of industrial experience.
Experience in translational biomarker discovery into diagnostic products that have achieved regulatory approval.
Experience in managing pivotal clinical program samples, overseeing testing and documentation necessary for regulatory approval.
Hands-on experience in developing immunoassays and optimizing products in singleplex and multiplex proteomics, and transcriptomics including molecular diagnostic techniques.
Experience working with external partners or collaborators (CROs, academic investigators, and diagnostic companies).
Familiarity with regulatory expectations and best practices for assay development, including verification and validation workflows to achieve regulatory approvals.
Experience in multiplex assay development and troubleshooting is highly desirable.
Proficiency in data management systems and tools is highly beneficial.
Excellent organizational, documentation, and communication skills, with the ability to clearly convey complex scientific concepts to multidisciplinary teams.
Proactive, adaptable, and self-motivated, with a strong can-do attitude and the ability to lead complex projects to completion.
Desirable Skills / Experience
Experience developing immunoassays in a regulated environment (e.g., In Vitro Diagnostics development standards or CAP/CLIA laboratories).
Experience of leading projects within a diagnostic organization.
Understanding of drug and companion diagnostic assay co-development and commercialization; experience in early and/or late phase projects.
Analytical diagnostic assay validation experience for clinical testing and/or regulatory submission.
Good computational and data analysis skills enabling automated or semi-automated analysis of large datasets (e.g., R, Python).
Knowledge of handling Human Biological Samples requirements.
In-Office Presence Please refer to the Hybrid and Remote Work Guidelines for in-office presence. The current in-office requirement is Tuesday, Wednesday, and Thursday each week.
Physical Demands / Misc
Must be able to remain in a stationary position 50% of the time.
Occasional movement within the office to attend meetings in different rooms.
Continuously operates a computer and may use other office productivity equipment.
Ability to communicate information clearly and accurately.
Ability to observe details at close range (within a few feet).
Medicines360 is committed to a diverse workplace and to equal opportunity employment for all job applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.
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$210,000 to $225,000
Overview Medicines360 is a womens health innovation organization focused on solving consequential issues and transforming novel ideas into life-changing products. We are dedicated to improving womens health worldwide and addressing pressing concerns with our launched products. For more information, visit Medicines360.org.
Position Title Senior or Principal Scientist, Diagnostics Product Development
Reports To TBD
Status Full-time
Location San Francisco Hybrid
Position Summary At Medicines360, we are developing tests for early detection and treatment of maternal health diagnostics to transform care. As a Senior or Principal Scientist, Diagnostics Product Development, you will utilize your knowledge of diagnostic technologies, including proteomics and transcriptomics, to drive the development of a set of biomarker tests for scalable, reproducible analysis of diseases that cause stillbirth. This role will contribute significantly to the scientific and technological direction of the diagnostics that are core to our maternal health development program.
Essential Duties and Responsibilities
Oversees laboratory-based diagnostic science and innovation projects with a focus on proteomics, collaborating with cross-functional teams.
Oversee pivotal clinical program sample collection, testing and documentation to meet regulatory requirements for US FDA approval.
Oversee the identification and development of select antibodies with high specificity and affinity for target proteins, including de-novo antibody development.
Manages the selection process of a CRO for the development of immunoassays.
Oversee the design and development of immunoassays for various biomarkers across diverse biological matrices, ensuring high-quality, reproducible data.
Ability to leverage experience with a range of technology platforms across proteomics and transcriptomics to select optimal platforms.
Work with outside vendors to develop and optimize assay parameters to meet performance requirements, including sensitivity, specificity, dynamic range, precision, and robustness.
Oversee the evaluation and integration of novel technologies, reagents, and workflow improvements to enhance assay performance and scalability for both singleplex and multiplex formats.
Oversee bridging studies and rigorous data analysis using appropriate bioanalytical and statistical tools to determine key assay performance characteristics and support regulatory submissions.
Provide technical expertise to support LDT and IVD submissions to regulating organizations.
Oversee the maintenance of accurate, thorough, and timely research documentation, and provide progress reports regularly.
Work cross-functionally with internal teams and external partners to ensure timely and accurate execution of project deliverables.
Oversee the authoring, maintaining, and review of assay development documentation, including technical reports, SOPs, and work instructions, ensuring traceability and compliance with industry standards.
Essential Skills & Qualifications
Ph.D. in Biochemistry, Molecular Biology, Systems Biology, Biochemical Engineering or a related discipline, with a minimum of 10+ years of industrial experience.
Experience in translational biomarker discovery into diagnostic products that have achieved regulatory approval.
Experience in managing pivotal clinical program samples, overseeing testing and documentation necessary for regulatory approval.
Hands-on experience in developing immunoassays and optimizing products in singleplex and multiplex proteomics, and transcriptomics including molecular diagnostic techniques.
Experience working with external partners or collaborators (CROs, academic investigators, and diagnostic companies).
Familiarity with regulatory expectations and best practices for assay development, including verification and validation workflows to achieve regulatory approvals.
Experience in multiplex assay development and troubleshooting is highly desirable.
Proficiency in data management systems and tools is highly beneficial.
Excellent organizational, documentation, and communication skills, with the ability to clearly convey complex scientific concepts to multidisciplinary teams.
Proactive, adaptable, and self-motivated, with a strong can-do attitude and the ability to lead complex projects to completion.
Desirable Skills / Experience
Experience developing immunoassays in a regulated environment (e.g., In Vitro Diagnostics development standards or CAP/CLIA laboratories).
Experience of leading projects within a diagnostic organization.
Understanding of drug and companion diagnostic assay co-development and commercialization; experience in early and/or late phase projects.
Analytical diagnostic assay validation experience for clinical testing and/or regulatory submission.
Good computational and data analysis skills enabling automated or semi-automated analysis of large datasets (e.g., R, Python).
Knowledge of handling Human Biological Samples requirements.
In-Office Presence Please refer to the Hybrid and Remote Work Guidelines for in-office presence. The current in-office requirement is Tuesday, Wednesday, and Thursday each week.
Physical Demands / Misc
Must be able to remain in a stationary position 50% of the time.
Occasional movement within the office to attend meetings in different rooms.
Continuously operates a computer and may use other office productivity equipment.
Ability to communicate information clearly and accurately.
Ability to observe details at close range (within a few feet).
Medicines360 is committed to a diverse workplace and to equal opportunity employment for all job applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.
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