Nicole Goulding
Project Manager at Pacira BioSciences, Inc.- Claim this Profile
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Bio
Experience
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Pacira BioSciences, Inc.
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United States
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Project Manager
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Apr 2023 - Present
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Fate Therapeutics Inc
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United States
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Biotechnology Research
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200 - 300 Employee
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Manager, Laboratory Operations
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Jun 2021 - Mar 2023
- Manage a team of Facilities Engineers and Laboratory Operations personnel responsible for maintaining equipment calibration and maintenance schedules for GMP and R&D equipment, ensuring no business disruptions due to equipment downtime. - Manage team of Inventory Specialists responsible for maintaining laboratory consumable, media, and reagent inventories, ensuring availability of supplies to all laboratory staff while also seeking best value on supplies ordered and efficient management of ordered materials. - Ensure continuity of various laboratory services by establishing and managing contracts for laboratory PPE, equipment maintenance, compressed gas deliveries, dry ice deliveries, etc. Show less
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Microchem Laboratory
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United States
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Research Services
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1 - 100 Employee
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Laboratory Manager
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Aug 2018 - Jun 2021
-Manage a team of Managers, each responsible for managing a team of Microbiologists specialized in a different area of antimicrobial efficacy testing (e.g. disinfectant testing, environmental monitoring, antimicrobial medical device testing, etc.). -Maintain expert knowledge in all microbiological assays offered by the laboratory and assist with study design and protocol development for highly customized or complex study designs. -Ensure compliance with all business SOPs and various regulatory agency requirements (FDA GLP, EPA GLP, USDA, etc.) and lead audits with government Agencies and various laboratory customers and consultants. Show less
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Vivo Clinical Testing
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Austin, Texas
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Laboratory Manager
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Jan 2017 - Jul 2018
- Manage a team of Managers, each responsible for managing a team of Microbiologists or clinical study subject Recruiters. - Maintain expert knowledge in all clinical microbiological assays offered by the laboratory. Design study approach and develop protocols for standard and highly customized study designs to evaluate antimicrobial efficacy of patient-contacting antimicrobials (e.g. hand sanitizers, surgical scrubs, etc.). - Develop and submit all documents required to support clinical microbiological studies to Institutional Review Boards (IRBs) to ensure that all trial-related documents are approved prior to study participant recruitment. - Serve as Principal Investigator on laboratory clinical microbiological studies, per pertinent GCP regulations, and recruit appropriate healthcare professionals to act as Principal Investigators for clinical studies that required specialized medical personnel oversight. Show less
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Microchem Laboratory
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United States
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Research Services
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1 - 100 Employee
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Team Lead - Medical Device Testing
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Mar 2015 - Dec 2016
- Manage a team of Microbiologists responsible for designing and conducting antimicrobial efficacy testing assays to support medical devices or patient-contacting antimicrobials.- Manage all day-to-day activities in the laboratory and resolve operational issues as they arise.
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Virology Team Lead
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Jul 2014 - Mar 2015
- Manage a team of nonclinical Virologists responsible for designing and conducting virucidal efficacy testing of new and innovative antimicrobial technologies. - Maintain cell cultures of permissive mammalian cell lines for testing with approximately 30 different test viruses.
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Microbiologist
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May 2013 - Jul 2014
- Design and conduct antimicrobial efficacy testing to support a wide range of antimicrobial technologies including disinfectants, sanitizers, treated antimicrobial surfaces, and antimicrobial devices.- Maintain laboratory media, reagents, standards, and microbial cultures/suspensions to sustain laboratory activities.- Prepare testing protocols, interpret study data, prepare reports summarizing testing method and results, and communicate technical study results to clients and consultants. Show less
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Genentech
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United States
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Biotechnology Research
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700 & Above Employee
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Bioprocess Technician
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2012 - 2013
- Prepare glassware, reagents, media, freeze/thaw tanks, filter assemblies, bioreactors, and miscellaneous small parts used to produce Genentech's clinical and commercial products. - Operate autoclaves, water systems, CIP and SIP systems to adequately reprocess drug manufacturing equipment, assemblies, and glassware. - Review quality control documentation to verify reprocessed equipment samples met acceptable limits of bioburden, conductivity, endotoxin, documenting non-conformance issues wherever observed. Show less
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Education
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University of California, Santa Barbara
Bachelor of Science (B.S.), Biological Sciences