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Reagent Manufacturing Jobs (NOW HIRING)

Madrona Venture Labs

Reagent Buyer & Planner

San Carlos, CA · On-site

$68K - $94K/yr

We are hiring for a Reagent Buyer & Planner to join our growing team. This role is responsible for ... The successful candidate will play a critical role in supporting manufacturing by managing raw ...

Roche

Reagent Manufacturing Supervisor - 2nd Shift

Tucson, AZ · On-site

$57K - $78K/yr

The Position As the Manufacturing Supervisor, you will be supporting a fast-paced operation to deliver diagnostic products and ensure continuous quality, schedule adherence, and efficient production.

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How much do reagent manufacturing jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for reagent manufacturing in the United States is $20.84, according to ZipRecruiter salary data. Most workers in this role earn between $16.35 and $23.32 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in reagent manufacturing?

To thrive in Reagent Manufacturing, you need a solid background in chemistry or biology, laboratory experience, and knowledge of good manufacturing practices (GMP). Familiarity with laboratory equipment, quality control systems, and safety protocols is typically required, along with potential certifications in chemical handling or laboratory safety. Attention to detail, problem-solving, and effective teamwork are crucial soft skills for ensuring accuracy and efficiency. These competencies ensure the consistent production of high-quality reagents, adherence to regulatory standards, and a safe work environment.

What are some common challenges faced by professionals in reagent manufacturing, and how can they be addressed?

Professionals in reagent manufacturing often encounter challenges such as maintaining strict quality control, managing contamination risks, and ensuring consistency across batches. Addressing these requires thorough adherence to standard operating procedures, regular calibration of equipment, and proactive communication within cross-functional teams, including quality assurance and production. Staying up-to-date with regulatory requirements and participating in ongoing training can also help mitigate these challenges and contribute to a reliable and efficient manufacturing process.

What is the difference between Reagent Manufacturing vs Laboratory Technician?

AspectReagent ManufacturingLaboratory Technician
CredentialsTypically requires a degree in chemistry or related field, sometimes certifications in chemical safetyUsually requires an associate's degree or certification in laboratory techniques
Work EnvironmentManufacturing plants, chemical production facilitiesResearch labs, clinical or industrial laboratories
Industry UsageUsed in chemical, pharmaceutical, and biotech industries for producing reagentsUsed across various labs for testing, analysis, and experiments

Reagent Manufacturing involves producing chemical reagents in industrial settings, focusing on large-scale production and safety protocols. Laboratory Technicians work in labs performing tests and analyses, often using reagents produced elsewhere. While both roles require chemistry knowledge, their work environments and responsibilities differ significantly.

What cities are hiring for Reagent Manufacturing jobs?

Cities with the most Reagent Manufacturing job openings:

What states have the most Reagent Manufacturing jobs?

States with the most job openings for Reagent Manufacturing jobs include:

What are popular job titles for Reagent Manufacturing?

Popular job titles for Reagent Manufacturing:

Reagent Manufacturing jobs near you
Infographic showing various Reagent Manufacturing job openings in the United States as of August 2026, with employment types broken down into 90% Full Time, 4% Part Time, 3% Contract, and 3% Nights. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $43,341 per year, or $20.8 per hour.

IVD Documentation Scientist, Manufacturing and Medical Device (Contract)

Palo Alto, CA • On-site

DELFI Diagnostics, Inc.
Biotechnology Research and Development • 51 - 200 employees
Learn more about DELFI Diagnostics, Inc.external

Contractor

Re-posted yesterday

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.

 
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)

$62 - $80 an hour
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.

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