IVD Documentation Scientist, Manufacturing and Medical Device (Contract)

DELFI Diagnostics, Inc. 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 addresses high-burden health challenges. The platform relies on fragmentomics—the discovery that cancer cells leave behind tell-tale patterns of cell-free DNA (cfDNA) fragments. FirstLook Lung, DELFI’s first laboratory-developed screening test, uses millions of data points to 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.

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

About the role

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 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. You will work closely with assay development, reagent manufacturing, regulatory, and quality teams to craft procedures, templates, and documentation governing high-quality reagent manufacturing execution.

Responsibilities

• IVD Documentation (Manufacturing and Medical Device):
  • Author and revise reagent manufacturing and qualification procedures to ensure repeatability and compliance with 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, 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, and trace matrix.
• CMO & Supplier Coordination:
  • 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.
• GMP Manufacturing Experience:
  • Hands-on experience in the preparation of GMP-grade reagents, controls, and reference standards (formulation, aliquoting, labeling, packaging) following SOPs and batch records.
  • Complete hands-on training and bench execution of step-by-step manual reagent preparation, identify potential failure modes, recommend improvements, and update 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.

Requirements

• 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.

Preferred Qualifications

• 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).