Senior Quality Control Microbiologist

2 weeks ago


Framingham, Massachusetts, United States Atlas Venture Full time
Company Overview:

Atlas Venture is dedicated to transforming the landscape of healthcare through innovative biopharmaceutical solutions. Our commitment is to develop groundbreaking therapies that address unmet medical needs.

Position Summary:

We are seeking a highly skilled and experienced Senior Quality Control Microbiologist to join our dynamic team. This role is crucial in establishing and maintaining microbiological quality control programs within our state-of-the-art manufacturing facility.

Key Responsibilities:
  • Develop and implement comprehensive QC Microbiology systems to meet testing requirements.
  • Establish and oversee environmental monitoring programs, including the qualification of cleanroom environments.
  • Lead the environmental monitoring initiatives, particularly in aseptic processing areas, and manage any deviations effectively.
  • Continuously enhance the environmental monitoring strategy in accordance with regulatory standards and industry best practices.
  • Contribute to the development of a robust contamination control strategy.
  • Conduct routine QC testing, including bioburden, endotoxin, and microbial identification.
  • Manage water sampling and testing protocols to ensure compliance.
  • Oversee change control processes and assist in investigations related to QC microbiology.
  • Prepare regulatory documentation and support audit processes as necessary.
  • Troubleshoot microbiological testing methods and equipment.
  • Coordinate microbiology-related studies with external partners and review findings.
Qualifications:

The ideal candidate will possess:

  • A minimum of 10 years of laboratory experience in a microbiology testing role within a GMP-regulated environment.
  • Strong analytical and technical skills, with a preference for those who have experience in laboratory setup and manufacturing support.
  • Proficiency in computer applications, including MS Word and Excel.
  • Excellent communication and organizational abilities.
  • Experience with regulatory audits and inspections is highly desirable.
Work Environment:

This position is based in a collaborative and innovative atmosphere, where teamwork and dedication to quality are paramount.



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