Job Description

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.

What you’ll do

IVD documentation (Manufacturing and Medical Device)

• 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

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

• 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

What you'll bring to DELFI

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

Preferred

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)