South San Francisco, California /
Operations – Product Development /
Full Time Employee
A Project/Product focused professional with a proven track record in building, aligning, and maintaining product portfolio candidates with a maniacal focus on patient experience and outcomes. Everything you do and say leads by example of how we take out technology into the clinic that helps change people’s lives. You don’t see departments, you see individual architects shaking the foundation of science and medicine. If this is you, read on.
We are not married to specific tools, technologies or shiny objects. We ask questions until we arrive at the best answer for the patient. We believe glycoproteins are a new language of biology we are translating for the benefit of patients, researchers, science and medicine. We have diverse backgrounds and experiences, skeptical about the status quo yet solution-oriented. If this sounds like a good fit, read on.
We are seeking a talented individual with a proven track record as one of our Program Managers. The desired candidates would have experience in developing diagnostic products and/or companion diagnostics. Working with multidisciplinary teams and the management team to achieve corporate goals and push products into the clinic are pivotal.
- Ownership of product portfolios in disease-specific areas
- Develop reporting methodologies, engage management team and update organization on product candidate advancements
- Work closely with Quality and Regulatory team to ensure clinical-grade quality to all products
- Coordinate and conduct risk identification and management strategies
- Drive several LDT test development and launch activities
- Lifecycle management of products at various stages
- BS in biological sciences, chemistry or analytical chemistry
- >5 yrs experience in managing a portfolio or product development experience
- Proven products entering the clinic and beyond
- Strong communication skills and ability to reach group consensus and decision making
- Experience in design control and device history file completion a plus
- Proven product design and launch in the healthcare industry (RUO/LDT/FDA preferred)
- Operated in GxP environments
- Risk management and strategic analysis is a must
- A genuine desire to impact patient lives