Principal Scientist, IVD Reagent Development and Manufacturing

Job Description

Job Description

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.

In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

• Lead with Science, Anchor in Pragmatism : We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.

• Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class 

• Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

About the role

• Own the IVD reagent development plan execution by developing reagent specifications and manufacturing processes for finished reagents that will be used for DELFI’s molecular diagnostic assays. 

• Lead the Reagent Development and Operations team and be accountable for Process Validation and Design Transfer from R&D to Operations.

• Define reagent criticality (Key, Ancillary, General Use) for DELFI's IVD molecular diagnostic assays, and develop reagent FMEA to inform testing rigor and change control requirements. 

• Develop and qualify QC test methods for reagent lot release, including method design, acceptance criteria, lot release procedures, and integration with batch manufacturing records.

• Evaluate Contract Reagent Manufacturers. Be the primary point of contact and be accountable for the completion of process development and the generation of pilot builds for R&D needs by developing various scopes of work (SOWs) and helping implement supplier agreements. Participate in Quality audits.

• Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities.

• Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists. 

• Develop IVD design documents required for PMA submission under Design Control to meet product development and project milestones.

What you'll do

• Own the IVD reagent development plan execution by developing reagent specifications and manufacturing processes for finished reagents that will be used for DELFI’s molecular diagnostic assays. 

• Lead the Reagent Development and Operations team and be accountable for Process Validation and Design Transfer from R&D to Operations.

• Define reagent criticality (Key, Ancillary, General Use) for DELFI's IVD molecular diagnostic assays, and develop reagent FMEA to inform testing rigor and change control requirements. 

• Develop and qualify QC test methods for reagent lot release, including method design, acceptance criteria, lot release procedures, and integration with batch manufacturing records.

• Evaluate Contract Reagent Manufacturers. Be the primary point of contact and be accountable for the completion of process development and the generation of pilot builds for R&D needs by developing various scopes of work (SOWs) and helping implement supplier agreements. Participate in Quality audits.

• Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities.

• Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists. 

• Develop IVD design documents required for PMA submission under Design Control to meet product development and project milestones.

What you'll bring

Required

• PhD with 8+ years or Master’s with 10+ years industry assay/reagent development with experience in Molecular Biology, Biochemistry, Chemistry, or a similar discipline 

• 3+ years of developing IVD diagnostic tests with NGS cfDNA/multi-omic assay technologies from plasma (e.g., DNA fragments, RNA, small variants, methylation, or immunoassays) under 21 CFR Part 820 or ISO 13485.

• 2+ years of experience developing reagent specifications (format, fill volume tolerance, closure, label, shelf, and in-use stability), reagent integrations with automated platforms, and transferring reagent manufacturing from R&D to an internal department or an external contract reagent manufacturer.

• Hands-on with reagent development for IVD or LDT product development experience, working in a regulated laboratory environment (GxP).

• Experience in writing protocols, designing experiments, analyzing, and documenting results in reports.

• Clear communication skills, ability to work with team members in the same and adjacent disciplines, and experience mentoring and training junior scientists and other cross-functional stakeholders to foster a collaborative, knowledge-sharing and data-driven culture.

• Ability to work on-site at our Palo Alto laboratory three to five days a week when required, with periodic travel to the reagent manufacturer sites for audit purposes.

Preferred

• Experience with IVD reagent kitting and reagent interchangeability

• Experience in developing reagent QC methods and Process Validation for reagent manufacturing.

• Experience in managing R&D relationships and auditing reagent suppliers.

Actual base pay will consider experience, skillset, education, and geography. This role may be eligible for other forms of compensation, including an annual bonus and a new hire equity grant, subject to the terms of the applicable plans and Company discretion. All employees are also eligible for DELFI's comprehensive and competitive benefits package, including but not limited to: a flexible time-off policy; a 401(k) retirement plan; an extremely competitive medical, dental, and vision coverage; onsite lunch 3 days a week; and other wellness related offerings.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.