IVD Documentation Scientist, Manufacturing and Medical Device (Contract)

DELFI Diagnostics, Inc. • Palo Alto, CA

3d • $62 - $80 • Hybrid

About The Position

DELFI Diagnostics is developing next-generation, blood-based tests to detect cancer using advanced machine-learning methods and fragmentomics. The company is 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 FDA's PMA and IVDR's Class C/D submission requirements. The focus will be on collaborating with assay development, reagent manufacturing, regulatory, and quality teams to create procedures, templates, and documentation for high-quality reagent manufacturing execution, including batch records, CoAs, study plans, reports, SOPs, and design history file content. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. The company 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.

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

• Equal opportunity employer
• Value diversity at our company
• Do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

What This Job Offers

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