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Sr. Manager - Microbiology

Baxter International Inc.

Marion, NCOnsitePosted 5 days ago$136,000 - $187,000 annually
Full TimeSenior LevelQuality (QA / QC)Medical Device
Original posting ↗

Summary

Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.

Job description

What you'll be doing

  • 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) and 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 with the objective of achieving quality, reliability and cost improvements.
  • Develops and ensures adherence to budget and reports on overspend as necessary to evaluate reason and possible corrections.
  • Manages the coaching, training and development process of subordinates.
  • Sustain a clean and safe work area using 6S principles.

What you'll bring

  • Bachelor's degree in Science, concentration in Biology or Microbiology, preferred.
  • Minimum 10 years professional experience in Quality, Manufacturing, Engineering or related field.
  • Minimum 7 years confirmed experience in cGMP related industry.
  • Minimum 5 years proven leadership/supervision and 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.
  • Demonstration of leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving skills.

Requirements

  • Bachelor's degree in Science, concentration in Biology or Microbiology, preferred.
  • Minimum 10 years professional experience in Quality, Manufacturing, Engineering or related field.
  • Minimum 7 years confirmed experience in cGMP related industry.
  • Minimum 5 years proven leadership/supervision and 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.
  • Demonstration of leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving skills.

Benefits

  • Medical & Dental Coverage
  • Life & Accident Insurance
  • Short & Long-Term Disability
  • Employee Stock Purchase Plan
  • 401(k) Matching
  • Flexible Spending Accounts
  • Educational Assistance
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave
  • Commuting Benefits
  • Employee Discount Program
  • Employee Assistance Program
  • Childcare Benefits

Company overview

Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.

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