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Gaithersburg, MD

Microbiologist Lead (Senior Level)

Microbiologist Lead (Senior Level)

FPC of Atlanta

FPC of Atlanta

Leading Biopharmaceutical Company is currently seeking a proactive and experienced Microbiologist Lead to join their team in Gaithersburg, MD. As the Microbial Control Lead, you will play a vital role in overseeing the Contamination Control Programs and executing the Microbial Control strategy.

This position involves collaborating closely with Operations, Quality, Engineering, Validation, and Facilities stakeholders. The successful candidate will lead Quality Risk Management initiatives and ensure the development of a robust microbial control strategy while supporting investigations related to contamination issues.

Key Responsibilities:

  • Establish and maintain microbial controls program to meet quality standards
  • Lead risk assessments for microbial controls and contamination investigations
  • Write and review Contamination Control Strategy
  • Coach contamination investigation teams
  • Participate in Quality Council to identify and report microbial trends
  • Analyze data to recommend improvements
  • Support new product transfers and equipment design for microbial control
  • Develop EM program, cleaning, and disinfection programs
  • Assist in developing gowning and qualification programs

Basic Qualifications:

  • BS/BA with 8+ years or MS/Ph.D. with 5+ years in pharmaceutical or biopharmaceutical industry
  • Experience in Process Microbiology, Contamination Control, or Quality Control Microbiology

Preferred Qualifications:

  • Excellent technical writing skills and attention to detail
  • Knowledge of cGMP, CFR, microbial risk assessments, and Quality by Design
  • Strong communication and interpersonal skills
  • Proficient in data analysis and computer skills

If you are a self-managed, detail-oriented professional with a passion for driving quality standards in the biopharmaceutical industry, we would like to hear from you. Apply now to join our client's dynamic team as a Microbiologist Lead.

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