Associate Director of Microbiology and Sterility Assurance, Baxter

Associate Director of Microbiology and Sterility Assurance

Baxter

Location:

United States, Marion

Category:

Health and Beauty

Contract Type:

Employment contract

Salary:

152000.00 - 209000.00 USD / Year

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Job Description:

The Associate Director of Microbiology & Sterility Assurance is a quality leadership role responsible for overseeing microbiological practices, maintaining sterile manufacturing operations, and ensuring regulatory compliance. The role includes supervising microbiology laboratory activities, conducting risk assessments, and leading a team to ensure product safety and efficacy in a manufacturing environment.

Job Responsibility:

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
oversee the microbiology laboratory
ensure compliance with regulatory requirements and industry standards
assess impact of new regulations and implement appropriate changes
maintain the company's sterile manufacturing operations
provide direct supervision of employees and lead a large team
conduct risk assessments and root cause analyses for sterility assurance and microbiology issues
develop and maintain positive relationships with cross-functional teams
participate in regulatory inspections and audits
manage department budget focusing on cost control and cost reduction
stay up to date with the latest industry trends and practices.

Requirements:

Bachelor's degree in a scientific field such as microbiology, pharmacy, or biology
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
strong analytical and problem-solving skills
excellent communication and interpersonal skills
experience with regulatory inspections and audits.

Nice to have:

Master's or PhD preferred
experience with regulatory inspections and audits.

What we offer:

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
insurance coverage for basic life, accident, short-term and long-term disability
Flexible Spending Accounts
educational assistance programs
Employee Assistance Program (EAP)
childcare benefits.

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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