Manufacturing Associate
Fluxergy Inc.
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Benefits offered by this job
Job summary
Fluxergy is seeking a Reagent Manufacturing Associate in Irvine to support the manufacturing, formulation, and transfer of molecular diagnostic reagents and assay components. You will execute production processes, perform precise liquid handling, and help move formulations from R&D into routine manufacturing.
The role blends laboratory science with manufacturing, enabling development and commercialization of innovative diagnostic products while adhering to quality systems and safety standards.
Qualifications
- Hands-on experience with precision pipetting and reagent preparation.
- Experience following SOPs, batch records, and controlled procedures.
- Experience in regulated manufacturing environments.
- Strong documentation and recordkeeping skills.
- Excellent attention to detail and commitment to quality.
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 and dispensing errors.
- Work safely in laboratory and manufacturing environments following PPE and biosafety rules.
- Calculate dilutions, concentrations, volumes, and quantities for formulations.
- Communicate formulation deviations or process concerns clearly.
- Support scale-up and transfer of formulations from R&D into manufacturing.
- Apply biology and biochemistry knowledge to support manufacturing activities.
- Complete manufacturing records, logs, calculations, and documentation in real time.
- Assist investigations related to deviations and nonconformances; support risk identification.
- Follow GLP, ISO 13485, and company Quality Management System requirements.
Skills
Education
Job description
Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system.
Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.
At the core of our company’s identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours.
Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system.
Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.
At the core of our company’s identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours.
Our product: https://vimeo.com/176673475
We are seeking a motivated and technically capable Reagent Manufacturing Associate to support the manufacturing, formulation, and transfer of molecular diagnostic reagents and assay components.
This role is ideal for someone with strong laboratory skills who enjoys working at the intersection of science and manufacturing. You will be responsible for executing production processes, preparing formulations, performing precise liquid handling, and supporting the transfer of new products and processes from Research & Development into routine manufacturing.
The successful candidate will understand both the procedural requirements of manufacturing and the scientific principles that influence reagent performance. This position offers an opportunity to apply laboratory expertise while contributing directly to the development and commercialization of innovative diagnostic products.
- Execute manufacturing processes for molecular diagnostic reagents and assay components.
- Perform accurate liquid handling using single-channel pipettes.
- Identify and correct common liquid handling issues including contamination, air bubbles, dispensing inconsistencies, and measurement errors.
- Work safely within laboratory and controlled manufacturing environments while following PPE, biosafety, and contamination-control requirements.
- Calculate dilutions, concentrations, volumes, and material quantities required for formulation preparation.
- Recognize and communicate formulation deviations, abnormalities, or process concerns.
- Support scale-up and transfer of formulations from R&D into manufacturing.
- Apply fundamental knowledge of biology, molecular biology, biochemistry, or related sciences to support manufacturing activities.
- Complete manufacturing records, logs, calculations, and controlled documentation accurately and in real time.
- Support investigations related to deviations, nonconformances, and manufacturing issues. Contribute to risk identification.
- Follow GLP, ISO 13485, and company Quality Management System requirements.
- Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Biotechnology, Chemistry, Genetics, or a related scientific discipline.
- 1+ years of laboratory, biotechnology, molecular diagnostics, pharmaceutical, medical device, or reagent manufacturing experience.
- Hands-on experience with precision pipetting and reagent preparation.
- Experience following SOPs, batch records, and controlled manufacturing procedures.
- Experience working in laboratory or regulated manufacturing environments.
- Strong pipetting and liquid handling proficiency.
- Experience preparing solutions, buffers, reagents, and biological formulations.
- Ability to perform dilution, concentration, and formulation calculations.
- Understanding of molecular biology concepts and biological reagent handling.
- Strong documentation and technical recordkeeping skills.
- Excellent attention to detail and commitment to quality.
- Experience with PCR, qPCR, sequencing, molecular diagnostics, or nucleic acid-based assays.
- Experience formulating diagnostic reagents, master mixes, enzyme preparations, buffers, or biological solutions.
- Experience working with enzymes, oligonucleotides, primers, probes, nucleic acids, or assay controls.
- Experience supporting technology transfer from R&D into manufacturing.
- Experience in ISO 13485, GLP, IVD, or regulated medical device environments.
- Experience with lyophilization processes.
- Knowledge of reagent stability and storage requirements.
- Recruiter Interview
- On-site Interview
- Decision
We are an early-stage company and may change our interview process from time-to-time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn’t presented.
- 95% medical benefit premiums paid by Fluxergy and covers employee, partner, and dependents
- 100% dental and vision premiums paid for employee, partner, and dependents
- 100% Life Insurance premiums paid for the employee
- 15 paid vacation days
- 2-week paid winter break
- 7 company paid holidays
- 5 paid sick days
- Wear lots of hats / accelerate your career growth!
- We are a flat organization by design - lots of visibility!
- Many of our current leaders started their career with Fluxergy!
Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic.
Fluxergy participates in the E-Verify program. Please clickhere,here, here for more information.
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