Laboratory Manager

JOB DESCRIPTION:

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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 bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

The Opportunity
This position works out of our San Diego CA location in the Abbott Infectious Disease Unit.

Were 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 Abbotts 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 Youll 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

• Bachelors 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Manager