Manufacturing Associate

Fluxergy Inc.; Irvine (CA); Sur place; USD 40 000 - 43 000; Plein temps

Avantages offerts par ce poste

Excellent Medical/Dental Benefits

15 paid vacation days

2-week paid winter break

7 company paid holidays

5 paid sick days

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Pipetting

Liquid handling

Documentation

Attention to detail

Formation

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

Outils

Single-channel pipettes

Description du poste

About Us

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.

About the Role

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.

What You Will Do

• 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.

What You'll Need to Have

• 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.

Preferred Qualifications

• 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.

Interview Process

Our interview processes my differ slightly from role-to-role; however, most of our interviews will follow a similar pattern:

• 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.

Benefits

Excellent Medical/Dental Benefits

• 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

Work - Life Balance Minded Time Off

• 15 paid vacation days
• 2-week paid winter break
• 7 company paid holidays
• 5 paid sick days

A Work Culture Which Believes in Promoting from Within

• 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!

Salary Range: $29.00 - $31.25/hr.

Additional Information

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.