Product Development Scientist

Duties:

• Work with a multidisciplinary team of mass spec scientists, automation engineers, data scientists, software developers and clinical researchers to develop LDT and IVD products for early detection of cancer in liquid biopsy samples.

• Provide technical expertise to support LDT and IVD submissions to regulating organizations.

• Manage execution of various product development studies.

• Assist in planning the strategy for product design, verification, validation, and technical transfer to CLIA lab.

• Provide leadership in experimental design, execution, and data analysis.

• Supervise testing to establish assay performance characteristics and support regulatory submissions.

• Supervise activities of direct reports and help mentor other junior level team members.

• Write detailed SOPs, protocols, and reports to support development of regulated products.

• Manage relationships with CRO’s and CMO’s involved in the IVD development.

• Evaluate and develop robust and economical methods to enrich low abundance analytes in plasma.

Requirements:

• PhD in biochemistry, analytical chemistry, or related field with 2+ years (Scientist) or 8+ years (Sr. Scientist) relevant industry experience.

• Prior experience in IVD product development required for Sr. Scientist level, strongly preferred for Scientist level.

• Prior management experience required.

• Experience with developing immunoassays highly desired, but not required.

• Experience with targeted Mass Spec assays is plus, but not required.

• Proven history of executing against timelines and reaching key milestones.

• Must work well in a small team setting, with ability to work independently and collaboratively while meeting deadlines.

• Highly organized, exceptional attention to detail and strong documentation skills.

• Must be able to organize work, multitask and manage time effectively.

• Excellent communications and presentation skills, as well as a desire to work across functional teams.

• Desire to focus on breakthroughs in an exciting, fast-paced startup environment.

• Ability and drive to solve practical problems.