Job description  –  Sterility Assurance Program Manager

Responsible for development, assessment, improvement, and maintenance of the manufacturing Aseptic Processing Program for the manufacturing operations. Individual should be able to work independently with little direction to review policies and procedures and related completed media fill/APS documentation, aseptic practices, cleamoom qualifications, environmental monitoring excursions, deviations and sterility failures. The individual is expected to interact manufacturing management, QC and QA leadership. Primary responsibility is to maintain sterility assurance of Aseptically manufactured drug products.
 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Compose a comprehensive manufacturing sterility assurance program which includes training, initial qualifications, and on going qualification
  • Observation of aseptic manufacturing and on the floor training of manufacturing associates
  • Leads cross-functional review of SOPs relating to sterility assurance
  • Must be capable of motivating others, creating a positive work environment and foster inter- departmental collaboration, coaching and performance feedback.
  • Must be capable of clearly assigning objectives, clearly setting and measuring and monitoring progress, managing resources and handling competing priorities.
  • Must be committed to continuous improvement, leveraging data and technology to maintain and improve quality standards
  • Manage personnel to meet business, quality, and safety requirements

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Bachelor’s or master’s degree in microbiology, biological science, or engineering required.
  • At least 10 year of GMP experience in the biologics industry. 3-5 years of management experience desired. Working knowledge of microbiological and sterility testing, media fills, sterility assurance, clean room qualification and management, and microbiological control strategy required.

 

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