IVD Documentation Scientist, Manufacturing and Medical Device (Contract)

Job Description

Job Description

About Us

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.

DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices

We are seeking an experienced scientist who is a subject-matter expert in GMP reagent manufacturing under ISO 13485 and IVD medical device documentation. This role will be the key individual responsible for the manufacturing documentation required for a high risk IVD device meeting the rigor of FDA’s PMA and IVDR’s Class C/D submission including Specifications and Procedures for Manufacturing, Packaging, Storage, Handling, Distribution and Process Controls. The focus will be working closely with the assay development, reagent manufacturing, regulatory, and quality teams to craft the procedures, templates, and documentation that govern high-quality reagent manufacturing execution, including batch records, CoAs, study plans, reports, SOPs, and design history file content.

• Author and revise existing reagent manufacturing and qualification procedures to ensure processes are repeatable and meet GMP and IVD quality documentation expectations including 21 CFR 820 and ISO 13485 requirements

• Author batch record templates and finalize batch manufacturing records (BMRs) for GMP reagent manufacturing processes, including incoming receipt, in-process, and release steps

• Develop Certificates of Analysis (CoAs) and specification documents for GMP-grade reagents, controls, and raw materials, aligned with regulatory expectations

• Write and maintain manufacturing study plans and summary reports for lot qualification, lot-to-lot variability, stability, and process characterization studies

• Draft and revise SOPs, work instructions, and manufacturing process descriptions for inclusion in the Device History Record (DHR) and Device Master Record (DMR)

• Develop and maintain Design History File (DHF) documentation packages to support PMA submission, including manufacturing development reports, risk assessments, and design transfer documentation, process validation, equipment and software qualification

• Compile and organize manufacturing evidence packages (batch records, qualification data, CoAs, validation reports) for regulatory submission

• Support other IVD documentation as needed, such as FMEA, BOMs, trace matrix 

• Review CMO-generated documentation (batch records, CoAs, deviation reports) for GMP compliance prior to lot release

• Support incoming QC workflows and receiving-to-release documentation for in-house and CMO-manufactured reagents

• Prior hands-on experience in the preparation of GMP-grade reagents, controls, and reference standards (formulation, aliquoting, labeling, packaging) following SOPs and batch records

• Ability to complete hands-on training and bench execution of step-by-step manual reagent preparation, observe and identify potential failure modes, recommend improvements, and update existing documentation to meet GMP/FDA/IVD expectations

• Work with reagent manufacturing operators to ensure QC testing and real-time batch records are completed during manufacturing runs

Required

• BS+7, MS+5, or PhD+3 years in GMP manufacturing or tech transfer within IVD, medical device, or pharma

• Hands-on experience with manual GMP manufacturing: reagent formulation, controlled preparation, aliquoting, labeling, and release QC testing

• Prior experience operating lab equipment in GMP-controlled environments with strict contamination control and cleanroom protocols

• Demonstrated expertise authoring GMP documentation: BMRs, CoAs, study plans, manufacturing reports, SOPs, and process validation packages

• Direct experience in eQMS document control, including creating, revising, and approving quality documents. 

• Direct experience contributing to FDA PMA, 510(k), or BLA/NDA submission packages — specifically manufacturing sections

• Strong working knowledge of 21 CFR Part 820, ISO 13485, and design control requirements

• Experience with CMO oversight including review of CMO-generated documentation

• Background in NGS-based assays, molecular diagnostics, or immunoassay platforms

• Hands-on experience with protein- or nucleic acid-based reagent manufacturing, including recombinant protein controls or reference standards

• Familiarity with DHF/DMR structure, CLSI guidelines, ISO 14971 risk documentation, and ERP/lot-tracking systems (e.g., NetSuite)

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.

This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.