Microbiologist, Research Associate Iii, Sterility Assurance

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

• Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Microbiology Laboratory Associate III

This is where your work saves lives

The research we do and the products we develop improve outcomes for patients around the world. As a Microbiology Laboratory Associate III at Baxter, your work supplies directly to making a significant impact on others. It's daring work-and you're not on your own. Our teams collaborate multi-functionally and lead by influence. Whether guiding a team through a project or leading direct reports, our research and development team is responsible for influencing others to achieve results.

Our colleagues within our R&D organization desire to work on products that make a significant difference in others' lives. We are motivated by the power of collaboration and are natural leaders who are skilled at influencing others.

Summary of Role:

The Plymouth Microbiology Laboratory Associate III will report to the Plymouth, MN Microbiology Laboratory Manager and be responsible for laboratory contract support, external contract testing labs and internal primary lab contact for Quality Management System (QMS) documentation.

What You'll Do:

• Support and co-lead the set up and maintenance of contract testing labs and microbiological testing.

• Coordinate and track contract testing lab activities for drug products and medical devices, including new product development, test method development & validation, and investigations.

• Ensure R&D microbiology lab and documentation supports the company's QMS and that the documents are audit ready and can effectively respond to auditor enquiries.

• Equipment procurement and assure vital validations and documentation.

• Hybrid position: onsite for up to 5 days/week to support personnel working in the micro lab. A portion of this person's work can be conducted from home with the specifics of the work from home arrangements to be coordinated with the Lab Manager.

• Support Lab Manager to maintain lab operations.

• Being responsible for lab resources and documentation to deliver on time, credible results.

• Support Lab Manager by assuring contract laboratories documentation and internal lab documentation are audit ready and team can effectively respond to auditor inquiries.

• Assure appropriate investigations are conducted, as necessary, at contract labs.

• Support Lab Manager to maintain laboratory operations, including adequate documentation required from lab personnel and for lab equipment.

• Where necessary, implement new procedures to support microbiological testing of products.

• Devise new approaches to complex problems through adaptations and modifications of standard technical principles.

• Provide regular updates to Sterility Assurance Management.

• Assure all work complies with Baxter's QMS and cGDP/cGMP/cGLP practices.

• Work with Quality team to ensure adequate documentation, input into computer systems, and being the point person for addressing quality issues.

• Determine process and structure of reporting test results between internal micro lab and contract testing labs.

What You'll Bring:

• Degree in Microbiology or related discipline.

• B.S, with more than 10 years of related experience.

• Or M.S. with more than 7 years of related experience.

• Or Ph.D. with more than 5 years of related experience.

• Extensive experience in laboratory methods and documentation, including:

• Ensuring documentation for Standard Operating Procedures, test results, supervising personnel training, and equipment qualifications.

• Sterility testing

• Antimicrobial testing

• Bioburden

• Biofilms

• Rapid Microbial Methods

• Experience working with contract laboratories.

• Excellent understanding of theories/practices applied by other teams outside the primary area of expertise.

• Experience in drug or medical device industries.

• Knowledge of sterilization (e.g. moist heat/steam or radiation).

• Experience participating in professional organizations.

Desirable Skills

• Strong Microbiology background and experience.

• Proven ability to coordinate and lead resources to ensure compliant and required documentation for contract testing laboratories and the internal R&D microbiology department.

• Experience leading multiple simultaneous projects and work activities.

• In-depth knowledge of cGDP/cGMP/cGLP practices and compliant documentation.

• Effectively operates in, and capable of facilitating, cross-functional teams.

• Knowledge of medical devices and/or pharmaceutical industry.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 to $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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