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 bringRequired- 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.
$180,000 - $230,000 a year
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.
