Director of Sterility Assurance

2 months ago


Columbia, South Carolina, United States BioTalent Full time
Lead Sterility Assurance and Microbiology Expert

We are seeking a highly experienced and skilled Associate Director of Sterility Assurance to join our team at BioTalent. As a key member of our leadership team, you will be responsible for developing and implementing sterility assurance and microbiology strategies, policies, and procedures for our manufacturing facilities.

Key Responsibilities:
  • Develop and implement sterility assurance and microbiology strategies, policies, and procedures for our manufacturing facilities.
  • Lead the implementation of quality systems procedures and handle compliance across the department.
  • Oversee and manage microbiology laboratory activities, including environmental monitoring, microbiology testing, and microbial identification.
  • Lead and manage a team of sterility assurance and microbiology professionals.
  • Participate in regulatory inspections and lead the quality assessment of internal operations and suppliers to assess any risks.
  • Develop a strategy to ensure and improve clean room controls with the facility to minimize risk and cross-contamination.
Requirements:
  • Significant experience with microbiology, sterility assurance, and aseptic processing within pharmaceutical/biotech manufacturing.
  • BS degree in Science, concentration in Biology or Microbiology, preferably.
  • Proven experience managing and leading teams.
  • Strong regulatory knowledge of industry standards related to sterile manufacturing and aseptic processing.
  • Experience with regulatory inspections and audits.

We offer a competitive salary, stock purchase program, tuition reimbursement, PTO, 401k match, medical/dental/vision coverage, and a genuine opportunity to make a difference in the development of life-saving projects.



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