Sr. Manager - Microbiology

Baxter International Inc.•Marion, NC

10d•$136,000 - $187,000

About The Position

The Sr. Manager - Microbiology leads microbiology testing activities for raw materials and finished goods at Baxter. The role develops supervisors and department leads, oversees testing procedures, ensures compliance with applicable quality and regulatory standards, and works with cross-functional teams to meet testing requirements and timelines. It also leads continuous improvement, manages budgets and team development, and maintains a clean and safe work area using 6S principles. The position supports Baxter’s mission to save and sustain lives by prioritizing product quality and patient needs. It operates within the Quality function, working both collaboratively and independently with colleagues across the organization. Overtime is worked as needed.

Requirements

Minimum 10 years of professional experience in Quality, Manufacturing, Engineering, or a related field.
Minimum 7 years of confirmed experience in a cGMP-related industry.
Minimum 5 years of proven leadership/supervision experience within an aseptic or sterile manufacturing site.
Knowledge of microbiology testing techniques, including bioburden, endotoxin, solution particulate matter detection, and microbial identification.
Familiarity with regulatory requirements including USP, FDA, and ISO standards.
Demonstrated leadership, communication, and interpersonal skills.
Strong analytical and problem-solving skills.
Must be authorized to work for any employer in the U.S.; visa sponsorship or transfer is not available.

Nice To Haves

Bachelor's degree in Science, preferably with a concentration in Biology or Microbiology.

Responsibilities

Develop a team of supervisors and/or department leads involved in microbiology testing of raw materials and finished good products.
Supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter.
Ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and other relevant regulations and standards.
Coordinate with cross-functional teams to address testing requirements and timelines in support of change controls, protocols, and engineering studies.
Collaborate with Quality Assurance to achieve timely resolution of deviations, investigations, and corrective actions related to areas of responsibility.
Participate in internal and external audits, including direct interfacing with regulatory agencies such as FDA.
Remain informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
Develop, maintain, and establish action plans as needed for Key Performance Indicators (KPIs) and Metrics to maintain and improve the efficiency and effectiveness of product testing processes.
Identify and lead continuous improvement projects to achieve quality, reliability, and cost improvements.
Develop and ensure adherence to budget, and report overspend as necessary to evaluate reasons and possible corrections.
Manage the coaching, training, and development process of subordinates.
Sustain a clean and safe work area using 6S principles.
Work overtime as needed.

Benefits

Medical and dental coverage starting on day one
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits
May be eligible for discretionary bonuses and long-term incentives