Associate Director of Microbiology and Sterility Assurance

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

The Associate Director of Microbiology & Sterility Assurance is a quality leadership role responsible for overseeing microbiological practices and ensuring compliance with regulatory standards in our North Cove manufacturing facility. This position plays a critical role in ensuring product safety and efficacy through rigorous microbiological testing, risk assessment, and contamination control within the manufacturing site. The role provides expertise and guidance in interpreting government regulations, guidelines and internal requirements to ensure compliance.

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 sterility assurance strategies, policies, and procedures for the manufacturing site.
• Develop and implement microbiology strategies, policies, and procedures including environmental monitoring, microbiological testing, and microbial identification; including identification of gaps, resolution of discrepancies, and development of action plans.
• Oversee the microbiology laboratory, including directing 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.
• Assess impact of new regulations and implement appropriate changes as well as lead development of process flows and procedures.
• Maintain the company's sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques.
• Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to lead a large team of employees.
• 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 positive 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.
• Handles department budget focusing on management of cost controls and cost reduction activities.
• 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 helpful.

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 $152,000 - $209,000 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 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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.

#LI-BAXGEN

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.