Job Details

ABOUT MEDICINES360

Medicines360 is a women's health innovation organization focused on solving consequential health issues and transforming ideas into life-changing products. We are dedicated to improving women's health worldwide. 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 closely 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 the 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 maintaining accurate, thorough, and timely research documentation, and make progress reports on a regular basis.
• Work cross-functionally with internal teams and external partners to ensure the 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.
• Experienced in translational biomarker discovery into diagnostic products that have achieved regulatory approval.
• Experienced 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 of 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.
• An understanding of drug and companion diagnostic assay co-development and commercialization and experience working in early and/or late phase projects.
• Demonstrable experience of analytical diagnostic assay validation, use in a clinical testing setting and/or delivery of regulatory submission.
• Good computational and data analysis skills enabling automated/semi-automated analysis of large datasets (e.g., R, Python).
• Knowledge of requirements related to handling of Human Biological Samples.

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.
• The person in this position may need to occasionally move throughout the office to attend meetings in different rooms.
• Continuously operates a computer and occasionally uses other office productivity machinery, such as copy machines and a computer printer.
• The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
• The ability to observe details at close range (within a few feet of the observer).

Medicines360 is committed to a diverse workplace and 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.