Senior Director of Microbiology and Sterility Assurance

1 week ago

Baddi, Himachal Pradesh, India beBeeSterility Full time ₹ 8,00,000 - ₹ 13,00,000
Key Responsibilities and Duties

This role involves overseeing the site's Sterility Assurance program to ensure adherence to internal, global, and regulatory standards. The primary subject matter expert for sterility assurance and microbiology-related matters will be responsible for developing and implementing contamination control strategies and management plans.

  • Strategic Leadership: Develop and implement sterility assurance and aseptic processing programs that meet or exceed regulatory requirements.
  • Aseptic Processing: Lead all aspects of aseptic processing, including environmental monitoring, media fills, smoke studies, and critical batch operations.
  • Team Management: Manage and mentor the Sterility Assurance team, providing clear direction, performance feedback, and professional development opportunities.
  • Risk Management: Oversee risk assessments and mitigation plans concerning sterility assurance, including material and personnel movement within production and microbiology areas.
Required Skills and Qualifications

To be successful in this role, you should possess:

  • A Master's degree in Microbiology, Biology, or a related scientific field.
  • A minimum of 10-15 years of experience in a cGMP-regulated industry, with at least 2-3 years in a leadership or managerial role focused on sterility assurance.
  • Expert knowledge of aseptic processing, cleanroom operations, environmental monitoring, and contamination control.
  • Extensive experience with regulatory inspections (e.g., USFDA, EMA) and a deep understanding of cGMP, ISO, and other relevant regulatory guidelines.
  • Strong leadership, project management, and problem-solving skills, with a focus on root cause analysis.
  • Excellent technical writing, verbal communication, and interpersonal skills.
Benefits

This role offers:

  • The opportunity to lead a team of professionals in a fast-paced, dynamic environment.
  • A competitive salary and benefits package.
  • The chance to develop and implement sterility assurance and aseptic processing programs that meet or exceed regulatory requirements.

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