Microbiologist

Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.

**In this role, you will**:

- Plan, execute, and oversee microbiological testing activities on medical devices, raw materials, and environmental samples in accordance with established protocols, regulatory requirements, and company policies.
- Perform various microbiological analyses, including sterility testing, endotoxin testing, bioburden determination, microbial identification, and microbial enumeration.
- Develop and validate microbiological test methods, ensuring accuracy, precision, and reliability of results.
- Design and implement protocols for environmental monitoring of manufacturing facilities and cleanrooms to ensure compliance with regulatory requirements.
- Perform identification and characterization of microorganisms using molecular biology techniques, including PCR, qPCR, and DNA sequencing.
- Collaborate closely with cross-functional teams, including Quality, Operations and Manufacturing, to provide microbiological expertise and support during product development and manufacturing processes.
- Interpret and analyze test results, identify trends, and communicate findings effectively to relevant stakeholders.
- Contribute to the maintenance and improvement of the microbiology laboratory's equipment, processes, and documentation, ensuring compliance with relevant quality standards and regulations.
- Analyze and interpret microbiological data, generating reports and documentation for internal and external stakeholders.
- Assist in the investigation of non-conformances, deviations, and out-of-specification results, identifying root causes and recommending corrective and preventive actions.
- Stay abreast of industry trends, regulatory changes, and advancements in microbiological techniques to continuously enhance our testing methodologies.
- Foster a culture of safety, quality, and continuous improvement within the microbiology laboratory and the broader organization.
- Uphold the highest ethical standards and promote a collaborative and respectful work environment.

**Basic Qualifications**:

- Bachelor or Master of Science in Microbiology, Biology, or a related field. Ph.D. is a plus.
- Hands-on experience as a Microbiologist in a medical device, pharmaceutical, or similarly regulated industry.
- Strong understanding of microbiology principles, aseptic techniques, and microbial identification methods.
- Proficiency in using a variety of microbiological tools and equipment, including but not limited to, microscopes, autoclaves, incubators, and laminar flow hoods.

**Preferred Qualifications**:

- Familiarity with relevant regulatory standards such as ISO 13485, FDA guidelines, and Good Manufacturing Practices (GMP).
- Excellent analytical skills and attention to detail, with the ability to accurately interpret and analyze complex data.
- Effective communication skills, both written and verbal, to convey technical information to diverse audiences.
- Experience in method development, validation, and verification is highly desirable.
- Ability to work independently, collaborate within cross-functional teams, and prioritize tasks in a fast-paced environment.
- Strong organizational skills, attention to detail, and the ability to work effectively in a collaborative team environment.
- Problem-solving mindset and the ability to contribute to root cause analyses and continuous improvement initiatives.
- Commitment to maintaining a safe and compliant laboratory environment and following best practices in laboratory techniques and safety protocols.
- Professional certifications in microbiology or related fields.
- Experience with biofilm studies and antimicrobial testing.
- Knowledge of cleanroom design and environmental monitoring.

**Join Our Team**

**Our Health and Wellness Offerings**:

- Bonus Plan Eligibility
- Employee Stock Option Plan
- Wellness Days
- Employee Assistance Program
- Inclusive Team Environment

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

Pay: $70,000.00 per year

Schedule:

- 8 hour shift

Work Aut