Reagent Production Chemist

Job Title: Reagent Production Chemist

Salary Range: $45,000 – $75,000 per year

Position Summary: The Reagent Production Chemist plays a critical role in Monobind’s manufacturing operations, responsible for the accurate and efficient production of immunoassay reagents that support the company’s high-quality diagnostic products. This hands-on position executes established compounding protocols at scales ranging from 10 mL to 400 L, maintains detailed documentation, ensures regulatory compliance, and collaborates closely with Production, Quality Control, and R&D teams to deliver consistent, high-performing reagents. This role is ideal for a detail-oriented, safety-conscious chemist or laboratory professional with strong practical skills in reagent formulation, documentation, and regulated manufacturing environments. The Reagent Production Chemist contributes directly to Monobind’s reputation for quality by ensuring reliable production of ELISA and CLIA immunoassay reagents and controls.

Essential Duties and Responsibilities:

• Producing immunoassay reagents based on established compounding protocols and records 
• Calculating required volumes and masses of reagent ingredients based on established records and directions from the Production Supervisor as well as Quality Control/Quality Assurance/R&D staff
• Reading, processing, and completing assigned work orders to meet product specifications and quality standards
• Recording detailed operational and production data on reagent production forms
• Managing inventory of incoming materials and finished Monobind products 
• Operating and maintaining laboratory equipment, including but not limited to pH meters, scales, compressed gas tanks, pipettes, centrifuges, magnetic stirrers, propeller mixers, etc
• Collaborating with the Production Supervisor, QC, and R&D to adjust reagent formulations and titrations as needed during production
• Receiving, inspecting, and verifying incoming raw materials for conformance to Monobind’s specifications and ISO requirements
• Performing routine and non-routine equipment maintenance, troubleshooting operational issues, and ensuring safety and efficiency per OSHA and ISO standards
• Maintaining a clean and organized work area while adhering to cGMP, cGLP, and ISO 13485 standards
• Participating in KPI and Production meetings to optimize manufacturing efficiency

Qualifications:

• Associate’s Degree or Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other science-related field.
• Working knowledge of cGLP, cGMP, Quality Systems with FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 13485 a plus
• Laboratory skills including measuring volumes by pipet and gravimetric methods, weighing solid material, handling compressed gas, handling typical chemistry lab equipment, using personal protective equipment (PPE), concentration and dilution calculations, and detailed record keeping
• Ability to lift up to 50 lbs and use equipment to move heavier objects. 
• Possess excellent writing capacity for production documentation 
• Ability to carry out instructions furnished in written, verbal, or diagram form
• Strong communication (verbal and written) and interpersonal skills
• Ability to balance workloads and multiple issues at once and have a good knowledge of, and computer skills in, MS Office, Excel and Word with the ability to quickly learn to use new software and Monobind’s internal software.
• Ability to demonstrate a sense of urgency and attention to detail in approach to day-to-day work, as well as ability to work independently or with others
• Possess a positive attitude and the ability to influence others

About Monobind:

Monobind Inc. is a private company headquartered in Lake Forest, CA. It is a global leader in diagnostic development and innovation since 1978. Monobind manufactures 60+ analytes immunoassay kits in ELISA and CLIA formats and semi-to-fully automated instruments, as well as clinical controls. All products are CE Marked and Monobind is FDA Registered and ISO 13485 Certified.