Laboratory Manager

Abbott • San Diego, CA

1d • Onsite

About The Position

This 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.

Requirements

• Bachelor’s Degree in related field
• 7 years of related experience

Nice To Haves

• 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.

Responsibilities

• 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

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior