JOB DESCRIPTION:The OpportunityThis position works out of our
San Diego, CA location in the Abbott
Infectious Disease Unit.
We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
The person hired in this role will be responsible for managing laboratory operations within a multi-disciplinary R&D environment supporting development of in vitro diagnostic (IVD) products. Ensures laboratories operate safely, efficiently, and in compliance with Abbott Quality System requirements, including FDA Quality System Regulation (21 CFR Part 820) and ISO 13485, as well as applicable biosafety standards.
What You'll Work On- Uses professional concepts and company objectives to resolve complex laboratory operational issues in creative and effective ways
- Applies comprehensive knowledge of laboratory operations to support R&D objectives in a regulated environment
- Ensures compliance with Abbott Quality Systems, FDA QSR, and ISO 13485 requirements
- Leads biosafety and laboratory compliance programs consistent with CDC, NIH, and OSHA regulations
- Establishes and enforces proper PCR laboratory workflow design (e.g., unidirectional workflow, physical segregation of pre- and post-amplification areas, contamination control practices) to minimize risk of amplicon contamination
- Implements and monitors controls such as dedicated equipment, consumables, cleaning protocols, and environmental monitoring to prevent cross-contamination in molecular workflows
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Maintains laboratories in an inspection-ready state and supports internal and external audits
- Manages lifecycle, calibration, and maintenance of laboratory equipment including freezers, centrifuges, PCR systems, analytical instruments, balances, and pipettes
- Coordinates equipment qualification, preventive maintenance, and vendor service contracts
- Oversees sample handling, biorepository operations, and chain-of-custody controls
- Supports compliant shipment and receipt of biological materials per IATA and DOT regulations
- Drives 5S implementation to maintain an organized, efficient, and safe lab environment supporting R&D Excellence.
- May determine methods and procedures on new assignments and provide guidance to staff
- Collaborates cross-functionally with R&D, Quality, Regulatory, EHS, and Facilities
- Drives continuous improvement initiatives to enhance operational efficiency and compliance
Required Qualifications- Bachelor's Degree in related field
- 7 years of related experience
Preferred Qualifications- Laboratory operations experience in regulated environments such as IVD, medical device, biotechnology, or pharmaceutical industries.
- Demonstrated knowledge of FDA QSR and ISO 13485 and their application to laboratory operations.
- 3 years of experience with biosafety programs and laboratory equipment management required.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $100,000.00 - $200,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Research and Discovery
DIVISION:ID Infectious Disease
LOCATION:United States > San Diego : 4545 Towne Center Court
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Exposure to temperatures below 60 degrees Fahrenheit/16 degrees Celsius or above 85 degrees Fahrenheit/28 degrees Celsius on a regular basis, Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Routine work with chemicals, Work at heights, e.g. ladders, scaffolds, catwalks, etc., Work in a clean room environment, Work requiring repeated bending, stooping, squatting or kneeling, Work with human blood or other potentially infectious materials, Work with infectious organisms or known infectious materials, Work with or near radiation sources and/or radioactive material
