Senior or Principal Scientist, Diagnostics Product Development

Job Description

Job Description

Salary : $ 210,000 to $225,000

ABOUT MEDICINES360

At Medicines360, we are more than a womens health innovation organization we are a catalyst for change. We are fearless in our pursuit of creative approaches to solving consequential womens health issues and transforming novel ideas into life-changing products that improve the lives of all women, and especially the underserved. We are fiercely dedicated to our mission of improving womens health worldwide. Our launched products address pressing health concerns of women, providing them with the products they need to live healthier, more fulfilled lives. For more information on Medicines360, please 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, drive the development of a set of biomarker tests for the scalable, and reproducible analysis of diseases that cause stillbirth. This role position will provide a significant contribution 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 vendor 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 maintain 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 :

Desirable Skills / Experience :

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 :

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.