Scientist

ACON Laboratories; San Diego (CA); On-site; USD 81,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Paid Holidays

Job summary

ACON Laboratories is seeking a Scientist to develop projects from early development through clinical studies, guiding research priorities and progress. You will design experiments, analyze data, and provide recommendations to advance product development.

The role may lead a team of Scientists, Research Associates, and Technicians, requiring strong immunoassay expertise and regulatory awareness for FDA 510K submissions.

Qualifications

• Ph.D. in chemistry, biochemistry or related field or BS with 3–5 years of Scientist experience in IVD.
• 3–5 years of assay development and improvement experience in a quality system environment.

Responsibilities

• Develop projects from early development to product transfer and clinical studies.
• Lead or participate in prioritization and planning of research activities.
• Design experiments, develop procedures, and train staff as needed.
• Investigate and solve complex technical problems and perform data analysis.
• Assist with 510K submissions and regulatory documentation.
• May supervise a small team of Scientists, RAs, or Technicians.

Skills

Lateral flow immunoassay

Fluorescence immunoassay

Immunoassay development

Infection disease immunoassay

Root-cause analysis

Project management

Troubleshooting

Education

Ph.D. in chemistry/biochemistry or related

BS + 3–5 years in Scientist role in IVD

Tools

Excel

Job description

At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company.

We are looking for a Scientist to develop projects, design and conduct research and development studies. This individual will contribute to decisions regarding research priorities to support the effective and efficient progression of product development, analyze data, and recommend directions for further study. In addition, the Scientist may lead a team of one or more Scientists, Research Associates, and/or Research Technicians in executing daily project activities.

Some Essential Duties and Responsibilities:

• Develop projects from early development, product transfer, manufacturing and clinical studies phases;
• Participate in decision making regarding research priorities of the department and provides information on feasibility of prospective projects;
• Develop research plan, design experiments and outline research procedures to be followed;
• Identify and provide training to subordinate personnel to carry out research;
• Investigate and develop new methods for solving complex technical problems;
• Plan research schedule according to timetable and establishes daily or weekly routines necessary to meet the timetable;
• Assist RA department for 510K submission;
• Conduct research using laboratory equipment, computer resources and libraries;
• Provide expertise in field of research to other department members;
• Provide knowledge and support of electrochemical biosensor development; and
• Perform and report analysis of data to monitor; and
• When required, may train and/or supervise from Scientist to Research Technician for daily project activities

Education and /or Experience:

• Ph.D. in chemistry, biochemistry or related, or a combination of bachelor’s degree and 3-5 years’ experience in a Scientist role in the IVD industry; and
• 3-5 years of experience in assay development and improvement process in a quality system environment.

Required Knowledge, Skills and Abilities:

• Must have experience on lateral flow and fluorescence immunoassay;
• Experience in immunoassay development with instrument read;
• Experience in infection disease immunoassay development such as HIV, Syphilis blood test;
• Strong troubleshooting and root-cause analysis skills;
• Demonstrated expertise in diagnosing and resolving complex technical issues
• Must be able to manage project and timelines effectively, organize work priorities and effectively interact with other team members;
• Knowledge of conducting clinical trial study and FDA 510K submission; and
• Must be able to use Excel program to present data and do basic statistical analysis.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At ACON it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The annual salary range for this position is $81,000 - $100,000.

ACON offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and ACON may amend, terminate, or enhance the benefits provided, as it deems appropriate