Associate Scientist - Assay Development

Autonomous Medical Devices Incorporated • Santa Ana, CA

426d • $70,000 - $85,000

About The Position

The Associate Scientist position at Autonomous Medical Devices Incorporated (AMDI) involves working within the Assay Development team to conduct experiments and studies aimed at developing novel molecular diagnostic and immunodiagnostic assays. The role emphasizes planning and executing experiments in a BSL2 environment, performing statistical analysis, and collaborating with cross-functional teams to support regulatory submissions and product launches. The position requires a strong focus on quality control processes and documentation, as well as the ability to communicate findings effectively.

Requirements

• Minimum of a Bachelor's Degree in biology, chemistry, Bioengineering, Chemical Engineering or equivalent.
• Minimum of 2 years' experience in diagnostics industry with experience in protein characterization/assays, reagent formulation and/or assay development.
• Background in analytical methodologies and statistical analysis is preferred.
• Experience with Good Laboratory Practices (GLP) and Good Documentation Practice (GDP) preferred.

Nice To Haves

• Advanced degree preferred.
• Collaborative and motivated team player with a positive attitude and solid work ethic.
• Sets specific goals and objectives to complete tasks on-time in an organized manner.
• Effectively communicates in both written and oral presentations on data generated.
• Excellent attention to detail, record keeping and a passion for accuracy and precision.
• Ability to work in a fast-paced environment with deadline-driven workflows.

Responsibilities

• Draft material specifications, manufacturing procedures, and equipment operating procedures.
• Prepare reagents and solutions as directed, using appropriate documentation methods.
• Execute experiments and studies as an independent contributor or as part of a team.
• Design moderately complex to multi-factor experiments with appropriate statistical power.
• Complete statistical analysis of data and present it in easy-to-understand graphs/figures.
• Provide written and/or oral updates to the team regarding data, progress, technical issues and troubleshooting efforts.
• Interface with QC and manufacturing staff to assist in reliable integration, scale up and tech transfer of manufacturing procedures.
• Participate effectively in developing QC procedures for incoming biologicals and subassemblies.
• Maintain accurate records of all lab work either in physical or electronic form.
• Participate in using Quality Management System and uphold AMDI's Quality Policy.
• Assist with other responsibilities and/or projects as the need arises.

Benefits

• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid holidays
• Tuition reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree