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Manager/Sr. Manager, Microbiology

Applied Molecular Transport
South San Francisco, CA
  • Expired: July 30, 2021. Applications are no longer accepted.

Position Summary:

AMT is seeking a person to fill the role of Quality Microbiology Manager/Sr. Manager. This position will be responsible for all quality microbiological sampling and testing, including raw materials, in-process materials, release test samples, stability samples and Environmental Monitoring. The ideal candidate would have experience in setting up a new microbiology laboratory and collaborating with contract testing laboratories for method transfers and material testing. This role supports both the Manufacturing and Development teams to create test protocols, plan testing, sample and test materials/environment, document processes and procedures, support test protocol execution and track results. In addition, assure that all activities are in compliance with FDA, GMP/GLP, ISO, and other national and international standards. The Laboratory Manager works closely with the Quality Director.

Job Requirements:

  • Experience designing and executing microbiological testing, Environmental Monitoring Program and scheduling
  • Responsible for micro product specification, sample collection, sample inventory, results analysis and reporting.
  • Experience with gowning procedures, aseptic technique and contamination control within a clean room environment is preferred.
  • Ability to lead investigations into deviations, analysis, and reporting of findings to larger team
  • Assist with developing and implementing laboratory procedures and installation of equipment and methods.
  • Manage staff including recruiting & hiring qualified and enthusiastic employees, performance management, training and development.
  • Establishes and implements quality assurance programs and maintains standards and records that document compliance with regulatory agencies.
  • Ensures the review of all quality control, proficiency testing, instrument maintenance, and quality assurance records, and any associated corrective action.
  • Review and approve laboratory expenditures, including outside lab testing, shipping, and supply orders.
  • Provide guidance to the Laboratory technicians to ensure that all laboratory processes are managed with the highest quality and efficiency.
  • Authority to approve payroll hours, to write performance reviews, and to provide feedback to HR on staffing needs.
  • Periodically review methods and audit in-house and contract testing laboratories to ensure compliance with regulations.
  • Approve laboratory supply orders and invoices related to supplies, shipping, and contract services.

Preferred Education/Experience:

  • Bachelor's degree or higher in a scientific or healthcare discipline preferred with minimum of 7-10 years of progressive experience in microbiology laboratory preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience managing people is desired.

Knowledge, Skills and Abilities:

  • Knowledge of laboratory regulations, protocols and procedures.
  • Analytical and critical thinking abilities.
  • Ability to comprehend and communicate instructions.
  • Ability to perform laboratory protocols and procedures.
  • Knowledge of safety and infection control standards.
  • Ability to work in a team environment.

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

Applied Molecular Transport

Address

South San Francisco, CA
USA

Industry

Food

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