Catalent

Senior Director, Microbiology and Sterility Assurance

Catalent

Bloomington, IN, USA
Full-TimeDepends on ExperienceSenior LevelPhd or Professional
Job Description

Catalent is seeking an experienced and motivated Senior Director, Microbiology and Sterility Assurance to join our growing team. This key role requires an individual who is a strategic leader with significant experience in microbiology and sterility assurance. The successful candidate will have an in-depth knowledge of microbiological principles, principles of aseptic manufacturing, and regulatory requirements.The ideal candidate is a highly organized individual who can work independently or as part of a team, and who is capable of effectively managing multiple projects and priorities. The Senior Director, Microbiology and Sterility Assurance should possess excellent communication and interpersonal skills, as well as a strong commitment to quality and customer satisfaction. Additionally, the Senior Director should have a strong background in regulatory compliance and the ability to provide guidance and support to ensure compliance across all sites.Required Qualifications:• Bachelor's Degree in a relevant scientific discipline, or equivalent combination of education and experience• At least 10 years' experience in Microbiology and Sterility Assurance• Demonstrated knowledge of microbiological principles, principles of aseptic manufacturing, and regulatory requirements• Proven ability to manage multiple projects and priorities• Excellent communication and interpersonal skills• A strong commitment to quality and customer satisfaction• Strong background in regulatory compliance• Ability to provide guidance and support to ensure compliance across all sites

Responsibilities:

  1. Develop and implement microbiological and sterility assurance strategies and plans to ensure regulatory compliance across all sites.
  2. Utilize microbiological principles and principles of aseptic manufacturing to ensure quality and customer satisfaction.
  3. Manage multiple projects and prioritize tasks efficiently.
  4. Monitor and review microbiological and sterility assurance documents and records for accuracy and compliance.
  5. Lead teams in the development of new products, process optimization, and troubleshooting.
  6. Manage and review laboratory operations, including safety and quality assurance.
  7. Ensure compliance with all relevant laws, regulations, and best practices.
  8. Provide guidance and training to ensure that all team members understand and follow the company’s microbiology and sterility assurance processes.
  9. Develop and maintain relationships with external stakeholders, including regulatory agencies.
  10. Monitor industry trends and keep abreast of new developments in the field of microbiology and sterility assurance.
Where is this job?
This job is located at Bloomington, IN, USA
Job Qualifications
  • ) Bachelor's Degree In Microbiology

  • Biochemistry

  • Or Related Science

  • ) Ten Or More Years Of Experience In The Pharmaceutical Industry And/Or Microbiology

  • ) Proven Experience In Managing A Microbiology Laboratory And/Or Sterility Assurance Program

  • ) Ability To Manage Complex Projects And Multi-Disciplinary Teams

  • ) Demonstrated Knowledge Of Current Good Manufacturing Practices (Cgmp) And Regulations

  • ) Excellent Communication And Organizational Skills

Required Skills
  • Risk Management

  • Quality Assurance

  • Process Improvement

  • Strategic Planning

  • Project Management

  • Data Analysis

  • Communication

  • Problem Solving

  • Negotiation

  • Leadership

  • Regulatory compliance

  • Microbiology

  • Cross-Functional Collaboration

  • Technical Expertise

  • Sterility Assurance

Soft Skills
  • Communication

  • Conflict Resolution

  • Time management

  • Interpersonal Skills

  • Organization

  • self-motivation

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Senior Director, Microbiology and Sterility Assurance in Bloomington, IN, USA is between $135,000 and $185,000 per year. The salary range for this position can vary depending on experience, qualifications, and other factors.

Additional Information
Catalent is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJuly 6th, 2023
Apply BeforeJanuary 14th, 2026
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About Catalent

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.

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