Molecular Diagnostics Reagent Manufacturing Specialist

Fluxergy Inc.; Irvine (CA); On-site; USD 40,000 - 43,000; Full time

Benefits offered by this job

Excellent Medical/Dental Benefits

15 paid vacation days

2-week paid winter break

7 company paid holidays

5 paid sick days

Job summary

Fluxergy Inc. seeks a Reagent Manufacturing Associate to support manufacturing, formulation, and transfer of molecular diagnostic reagents and assay components.

You will execute production processes, prepare formulations, practice precise liquid handling, and help transfer new products from R&D to routine manufacturing. The role demands a solid lab background, ability to work in a regulated environment, and familiarity with SOPs and batch records.

Qualifications

• Bachelor's degree in a scientific discipline as listed.
• 1+ years in lab, biotech, molecular diagnostics, pharma, medical device, or reagent manufacturing.
• Hands-on experience with precision pipetting and reagent preparation.
• Experience following SOPs, batch records, and controlled procedures.

Responsibilities

• Execute manufacturing processes for molecular diagnostic reagents and assay components.
• Perform accurate liquid handling using single-channel pipettes.
• Identify and correct liquid handling issues including contamination, air bubbles, dispensing inconsistencies, and measurement errors.
• Work safely within lab and controlled manufacturing environments following PPE and biosafety requirements.
• Calculate dilutions, concentrations, volumes, and material quantities for formulations.
• Communicate formulation deviations or process concerns.
• Support scale-up and transfer of formulations from R&D to manufacturing.
• Apply knowledge of biology and biochemistry to support manufacturing activities.
• Complete manufacturing records, logs, calculations, and controlled documentation in real time.
• Assist investigations related to deviations and nonconformances and support risk identification.
• Follow GMP, ISO 13485, and company QMS requirements.

Skills

Pipetting

Liquid handling

Documentation

Attention to detail

Education

Bachelor's degree in Biology / Molecular Biology / Biochemistry / Biotechnology / Chemistry / Genetics or related

Tools

Single-channel pipettes

Job description

Fluxergy Inc. seeks a Reagent Manufacturing Associate to support manufacturing, formulation, and transfer of molecular diagnostic reagents and assay components.

You will execute production processes, prepare formulations, practice precise liquid handling, and help transfer new products from R&D to routine manufacturing. The role demands a solid lab background, ability to work in a regulated environment, and familiarity with SOPs and batch records.