Manager, Microbiology
Elkton, MD, US
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
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.
Job Details/Responsibilities
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.
Job Responsibilities (continued)
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
Knowledge, Skills and Abilities (KSA)
- 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
Qualifications/ Background Experiences
- 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
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.
Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay: $135,000 - $200,000/year