Job Description
Job Description
Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.
We are seeking an experienced Microbiologist to join our Quality team. As an integral member of our company, you will play a pivotal role in ensuring the safety, quality, and efficacy of our medical devices by conducting rigorous microbiological testing, analysis, and research. The successful candidate will have a deep understanding of microbiology principles, hands-on experience with various microbiological techniques, and a proven track record of working in a regulated industry.
In this role, you will:
- Perform Environmental Monitoring (EM): Acknowledge Alarms and alerts for Cleanrooms and take actions when necessary.
- Own EM Excursion NCMR (Investigate and implement actions/solutions)
- Schedule/Review EM Monitoring and Testing with external vendors
- Require experience in Cleanroom Validation and Re-Certification Activities
- Perform Valve, DS, ES, Crimper Sterilization Report Review
- Liquid Sterilization (PO - Propylene Oxide) experience preferred.
- Own Sterile Valve Release process
- Need to be familiar with and experienced in highly skilled Aseptic Techniques with handling products and samples in Biological Safety Cabinets
- Need to be familiar with and experienced in Precision Pipetting in 96-Well Plates
- Need Strong capabilities in Good Documentation Practice
- Be able to create in house Microbiology Lab testing capability. Specifically, hands on experience in following testing in a Microbiology Lab will be a plus:
- Airborne Particulate Monitoring using Particle Counter (Non-Viable and Viable Particulate)
- Air Change Rate and HEPA Filter Efficiency using Photometer Scan
- Viable Active Air monitoring using Active Air Sampler
- Surface Sampling using Contact Plates
- Personnel Sampling using Swabs
- Cleanroom Temp, Humidity and Pressure Differential monitoring
- Familiarity with sample collection, extraction, filtration, sample incubation, enumeration, analyzing results and create reports.
Skills, Knowledge, Experience & Qualifications
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.
- Experience in Raw material, in - process. Pre-Sterile, finished product, process water, Bioburden and Endotoxin testing
- Experience in Post Sterilization product sterility testing
- Experience in Sterilant pH and Concentration testing
- Sterilization Validation expertise
Compensation:
Target base salary range: $60,000 – $90,000, plus annual incentive opportunity and equity eligibility. Final compensation will be based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
What We Offer:
- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Inclusive Team Environment - collaborative and dynamic work environment with a culture of innovation and excellence.
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings:
- Medical, Dental, and Vision Plans
- Flexible Spending Account (FSA)
- 401k + Company Match
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Equity Program
- Paid Holidays & Vacation
- Employee Assistance Program
This is the national market pay scale.
Salary Range$60,000—$90,000 USD
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.