Sr. Manager - Microbiology

Baxter•Marion, NC

About The Position

The Sr. Manager - Microbiology leads a team of supervisors and/or department leads responsible for microbiology testing of raw materials and finished products. The role oversees product testing, ensures compliance with applicable quality and regulatory requirements, and coordinates with cross-functional partners to meet testing needs and timelines. It also supports audits and regulatory interactions, monitors performance metrics, leads continuous improvement, manages budgets, and develops subordinate employees. The position is part of Baxter’s Quality function, which supports products shipped worldwide and emphasizes patient safety, quality, collaboration, accountability, and continuous improvement. The role is based in a plant or office environment with opportunities to collaborate. 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 or supervisory 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.

Nice To Haves

Bachelor’s degree in Science, with a concentration in Biology or Microbiology, preferred.

Responsibilities

Develop a team of supervisors and/or department leads involved in microbiology testing of raw materials and finished 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 interaction with regulatory agencies such as the FDA.
Stay informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
Develop, maintain, and establish action plans as needed for KPIs and metrics to maintain and improve product testing efficiency and effectiveness.
Identify and lead continuous improvement projects to improve quality, reliability, and cost.
Develop and adhere to the budget, reporting overspending and evaluating reasons and possible corrections.
Manage the coaching, training, and development of subordinates.
Maintain a clean and safe work area using 6S principles.

Benefits

Medical and dental coverage beginning on day one.
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contribution options 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.
Childcare benefits.
The position may be eligible for discretionary bonuses and long-term incentives.