IVD Documentation Scientist, Manufacturing and Medical Device (Contract)

DELFI Diagnostics • Palo Alto, CA

1d • Hybrid

About The Position

DELFI Diagnostics is developing next-generation, blood-based tests for cancer detection using advanced machine-learning methods and a platform called fragmentomics. The company aims to save lives globally, especially for underserved populations. Their first test, FirstLook Lung, is for individuals eligible for lung cancer screening. DELFI Diagnostics is seeking an experienced scientist with expertise in GMP reagent manufacturing under ISO 13485 and IVD medical device documentation. This role will be crucial in creating the necessary manufacturing documentation for a high-risk IVD device, ensuring compliance with FDA's PMA and IVDR's Class C/D submission requirements. The scientist will collaborate with assay development, reagent manufacturing, regulatory, and quality teams to develop procedures, templates, and documentation for high-quality reagent manufacturing execution, including batch records, CoAs, study plans, reports, SOPs, and design history file content.

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.

Nice To Haves

• 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).

Responsibilities

• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior