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Sr Microbiology and Sterility Assurance Manager

ID de la oferta JR - 127731 Ubicación Marion, Carolina del Norte, Estados Unidos Categoría de Trabajo Regulatory Affairs Fecha de publicación 04/18/2024

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Your Role at Baxter

This is where your creativity addresses challenges

We are seeking an expert Sr Microbiology and Sterility Assurance Manager to join our pharmaceutical company. The successful candidate will be responsible for establishing and maintaining the microbiology and sterility assurance program for the company's manufacturing facilities, ensuring compliance with regulatory requirements and industry standards.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What we offer from Day One

  • Medical, Dental and Vision coverage
  • 160 hours of Paid Time Off and Paid Holidays
  • 401K match
  • Employee Stock Purchase Program
  • Paid Parental Leave
  • Tuition Reimbursement

What you'll be doing

  • Develop and implement microbiology lab and sterility assurance strategies, policies, and procedures for the company's manufacturing facilities.
  • Develop and implement microbiology strategies, policies, and procedures for the company's manufacturing facilities, including environmental monitoring, microbiological testing, and microbial identification.
  • Oversee the day-to-day operations of the microbiology laboratory, including managing a team of microbiology professionals, scheduling, and prioritizing testing activities, and ensuring timely and accurate release of products.
  • Ensure compliance with regulatory requirements and industry standards, such as FDA, EMA, PICs, USP and ICH guidelines.
  • Maintain the company's sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques.
  • Lead and manage a team of sterility assurance professionals, providing guidance, training, and support as needed.
  • Conduct risk assessments and root cause analyses for sterility assurance and microbiology issues and develop corrective and preventive actions to address them.
  • Develop and maintain strong relationships with cross-functional teams, including manufacturing, quality control, and research and development, to ensure effective communication and coordination of microbiology activities.
  • Collaborate with cross-functional teams to ensure effective communication and coordination of sterility assurance activities.
  • Participate in regulatory inspections and audits and respond to inquiries and observations from regulatory authorities.
  • Stay up to date with the latest industry trends, developments, and standard methodologies in sterility assurance and microbiology.

What you'll bring

  • Bachelor's degree in a scientific field such as microbiology, pharmacy, or biology; Master's or PhD preferred.
  • Minimum of 10 years of experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufacturing.
  • Strong knowledge of regulatory requirements and industry standards related to sterile manufacturing and aseptic processing.
  • Strong knowledge of regulatory requirements and industry standards related to microbiology, including environmental monitoring, microbial identification, and microbiological testing.
  • Excellent leadership and team management skills, with the ability to motivate and develop teams to achieve goals.
  • Strong analytical and problem-solving skills, with the ability to conduct root cause analyses and develop effective corrective and preventive actions.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate complex technical information to non-technical collaborators.
  • Experience with regulatory inspections and audits is preferred.

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

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 $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, and/or long-term incentive. 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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