
Senior Director, Microbiology and Sterility Assurance
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:
- Develop and implement microbiological and sterility assurance strategies and plans to ensure regulatory compliance across all sites.
- Utilize microbiological principles and principles of aseptic manufacturing to ensure quality and customer satisfaction.
- Manage multiple projects and prioritize tasks efficiently.
- Monitor and review microbiological and sterility assurance documents and records for accuracy and compliance.
- Lead teams in the development of new products, process optimization, and troubleshooting.
- Manage and review laboratory operations, including safety and quality assurance.
- Ensure compliance with all relevant laws, regulations, and best practices.
- Provide guidance and training to ensure that all team members understand and follow the company’s microbiology and sterility assurance processes.
- Develop and maintain relationships with external stakeholders, including regulatory agencies.
- Monitor industry trends and keep abreast of new developments in the field of microbiology and sterility assurance.
) 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
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
Communication
Conflict Resolution
Time management
Interpersonal Skills
Organization
self-motivation
Critical thinking
Teamwork
Adaptability
Problem-Solving
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.
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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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