JOB DETAILS

Scientist III, QC Micro

CompanyGoodwin Biotechnology Inc
LocationPlantation
Work ModeOn Site
PostedApril 27, 2026
About The Company
GBI, based near Fort Lauderdale, Florida, is a fully integrated, customer-focused cGMP Contract Development Manufacturing Organization (CDMO) of Biosimilar and innovative monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other bioconjugates. GBI offers a wide range of Single Source Solution services, including cell line development, GMP master cell banking, proof-of-concept development, cell culture, purification, and bioconjugation process development, scale-up, GLP pilot manufacturing for Tox animal studies, and cGMP manufacturing with fill & finish for human clinical trials. These core services are complemented by full support relative to assay development and qualification, analytical and microbiological Quality Control (QC), and Quality Assurance and Regulatory Affairs (QA/RA). With over 20 years of experience as an independent contract development and manufacturing service provider, GBI has worked with organizations of all sizes, from academic research institutions and virtual biotech start-ups to large, established multinational corporations.
About the Role

Description

Scientist III, QC Micro is responsible for managing the Microbiology staff and laboratory. Create, review and revise SOPs related to testing and sampling. Organize and schedule Microbiology activities. Represent QC Microbiology in production meetings and other meetings as required. Participate in audits, if necessary. 

Requirements

  • Supervised the Microbiology Laboratory and staff.
  • Ensure competent performance of microbiology personnel.
  • Create or revise departmental SOPs.
  • Manage verification of USP compendia] methods related microbiology by writing verification protocols, execution of the protocols and authoring the reports.
  • Maintain the quarterly report for the Microbiology lab tracking all Alerts, Actions, or OS.
  • Maintain the quarterly EM trending of GMP areas, HPW reports and QC lab monitoring.
  • Perform all relevant microbiology tests and reports.
  • Review and approve all micro test results.
  • Maintain, review, and approve all equipment logbooks associated with the Microbiology Lab.
  • Coordinate in-house and outside testing.
  • Keep Microbiology area in a tidy, always organized and in a sanitary condition.
  • Create, execute, and compile qualification/validation protocols and reports related to Microbiology.
  • Write deviations, investigations, OS and change control reports.
  • Conduct training for new recruits and company-wide on topics pertaining to microbiology and aseptic technique.
  • Uses NetSuite in ordering/inventory of lab supplies.
  • Works with communicating and supporting all departments. 1 7. Communicate with outside venders and contractors.
  • Monitor USP compendia and other standards to ensure procedures and processes are current with industry standards.
  • Monitor Manual vial filling and Machine Filling operations for Media and product filling.
  • Supervise Vial Visual Inspection. 

Education and Experience Required:

  • Master's degree in Microbiology, Biology, or related scientific field.
  • Minimum 7 years of hands-on QC Microbiology experience in a GMP-regulated environment, with prior leadership or team lead experience strongly preferred.
  • Proven proficiency in microbiological testing including bioburden, endotoxin (LAL), sterility testing, environmental monitoring, water testing, microbial identification, and growth promotion testing.
  • Experience with deviations, OOS/OOT investigations, CAPAs, change controls, and SOP authorship/revision.
Key Skills
MicrobiologyQC MicrobiologyGMPSOP DevelopmentBioburden TestingEndotoxin TestingSterility TestingEnvironmental MonitoringWater TestingMicrobial IdentificationGrowth Promotion TestingCAPAOOS InvestigationsChange ControlAseptic TechniqueLaboratory Management
Categories
Science & ResearchHealthcareManagement & LeadershipManufacturing
Job Information
📋Core Responsibilities
The Scientist III manages the Microbiology laboratory staff and operations, including scheduling, SOP creation, and ensuring compliance with USP compendia. They are responsible for overseeing environmental monitoring, conducting investigations, and representing the department in production and audit meetings.
📋Job Type
full time
📊Experience Level
5-10
💼Company Size
89
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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