Job Description

The Manager, Microbiology directs the department and manages the controlled environment monitoring programs. This manager will serve as subject matter expert to Quality Assurance, Engineering and Production concerning environmental control. The manager will maintain current knowledge of ISO, QSR and government regulations. This individual will represent TMC as a member of industry and government organizations, such as AAMI, PDA and ISO. S/he will be responsible for developing, qualifying, and overseeing in-process and finished product testing (testing essential for ability to manufacture and release product for shipment to meet sterility assurance requirements). Additionally, this position will be managing a group of associates.

1. Manager is responsible to follow requirements of applicable national and international regulations

2. Maintain current knowledge on GMP, FDA, and ISO regulations and serves as a subject matter expert for microbiology and controlled environment monitoring programs.

3. Develops and manages the company’s Microbiology and environmental monitoring programs for compliance with all applicable regulations.

4. Develops and manages the company’s Environmental monitoring program for compliance with all applicable regulations, including water, air, and product. Includes responsibility for verification of environmental conditions for manufacturing environments.

5. Manage daily operations of the microbiology laboratory.

6. Provide technical guidance and support to Quality Assurance, Engineering, Regulatory and Operations on project teams including requirements for environmental control.

7. Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the TMC Quality System and Terumo’s Provide guidance and responses for regulatory submissions regarding bioburden, bacterial endotoxin, and related testing.

8. Provide guidance and responses for regulatory submissions regarding bioburden, bacterial endotoxin, and related testing.

9. Establish and maintain technical vendor relationships with laboratories and others. Audit vendors as necessary

10. Develop and execute test methods and validation protocols

11. Continually examine the scope of testing services being performed to assure that the needs of TMC are met and that regulatory guidelines are followed

12. Manage and develop associate staff and others to continually upgrade skill levels on the team

13. Provide training to associates on contamination control and reduction of product bioburden

14. Assist in performing daily laboratory work as required

15. Participate in project performance team meetings on behalf of the section to provide ideas, methods, or processes for unit/company performance improvement

16. Develop and manage budget for area of responsibility

17. Perform other job-related duties assigned

• Specialized training is required in clean room certification requirements and microbiological test methods (aseptic techniques, bioburden, LAL, etc.)
• Proven ability to stay current with information related to Microbiology and how it affects products for decision making.
• Proven ability to make day to day decisions within scope of the functional area
• Extensive understanding of microbiological methods and ISO controlled/cleanroom environments
• Must be proficient in using spreadsheet, word processing and database software

Requirements

• Bachelor’s degree in biology, microbiology or related science required or equivalent combination of education and relevant prior work experience.
• Advanced degree preferred.
• Minimum of 10 years work experience within field to acquire needed skills
• Previous supervisor or management experience required

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