Senior Scientist - Ivd Development

Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development.

Predicine has developed an international business utilizing its innovative liquid biopsy technology and molecular insights to empower biopharma partners in clinical drug development and expand opportunities around new oncology medicines. Fully recognized by global industry leaders, we are partnering with the top 10 MNC BioPharma’s to support biomarker-driven clinical trials in US, EU, APAC including China.

At Predicine, we believe people are our most important asset and we are dedicated to creating a great place to work. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.

We invite people who share the same values to join us !

In this role, you will be responsible for strategic design in the assay validation under design control for Predicine’s global NGS assays with particular focus on IVD product development. The role is intended to be a technical lead for performing analytical validation studies under the design control environment. In this role, there are three strategic areas of focus: understanding the validation design to conduct the experiment, proactively prepare samples including contrived and clinical samples for the validation process and collaborate with multiple departments to ensure the smooth analytical validation progress, and troubleshooting the process and understanding the validation data. All of these efforts will support the IVD product development of liquid biopsy oncology products.

You will work cross-functionally with team members from across the and you must be able to operate in a fast-paced organization and have extremely high standards and accountability on quality of deliverables. This is an exciting opportunity to join a fast-growing startup to accelerate your growth, contribute, and make an immediate impact on cancer care worldwide.

Responsibilities

• Apply expert knowledge of molecular biology and next generation sequencing to develop IVD products following the design control requirements.
• Design and conduct experiments to move products forward through all stages of the development from feasibility, development to IVD product.
• Drive for critical decisions during the product development based on risk management, scientific principles, and product/customer requirements.
• Collaborate with operation and automation groups to build the process for verification and validation studies.
• Understands project goals and commits to deliver projects within a deadline, willing to present data in front of cross functional team members.
• Responsible for study protocol and report preparation, or other technical documents per product requirements.
• Communicate effectively within the group and other cross-functional groups.
• Provide a deep understanding on validation study design to meet the regulatory needs.

Who You Are

• PhD degree in molecular biology, or closely related filed, or 3+ years technical experiences in applicable areas such as NGS, oncology.
• Good skills in experimental design, data organization and result interpretation, and familiar with laboratory procedures, SOPs and instruments
• Critical thinking and effective troubleshooting skills.
• Solid knowledge with the NGS-related research area such as NGS, molecular biology, genetics, cancer biology or related areas.
• Be willing to work in the lab and learn FDA and other regulatory authorities’ guidelines on general principles related to validations.
• Proven proficient in reading and communication skills.
• Good team player and willing to work cross-functionally with multiple groups including working with lab operations, quality, regulatory and marketing teams.
• Highly self-motivated and work with a sense of urgency

We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.

Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.