Sterility Assurance Program Manager

Bio-Techne • Saint Paul, MN

5d • Onsite

About The Position

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. The Sterility Assurance Program Manager is responsible for the development, implementation, oversight, and continuous improvement of the sterility assurance program within a GMP-regulated manufacturing environment. This role ensures that all processes related to aseptic processing, sterilization, and contamination control meet regulatory requirements and internal quality standards to guarantee product sterility.

Requirements

• Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing, aseptic process simulations (media fills), and process validations.
• Proven experience in the qualification and training of manufacturing personnel in aseptic techniques and sterility assurance requirements.
• Experience owning, executing, and reporting on aseptic process validations in compliance with regulatory standards.
• In-depth knowledge of EU GMP Annex 1 and the ability to apply its requirements effectively in a manufacturing environment.
• Familiarity with regulatory requirements including FDA cGMP, EMA, USP <71>, ISO 13485, and related standards.
• Experience with risk management methodologies and tools (e.g., FMEA, HACCP).
• Proven experience in managing sterility assurance programs and leading cross-functional initiatives.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills.
• Ability to influence and drive changes in a complex, regulated environment.
• Detail-oriented with strong documentation and record-keeping skills.
• Bachelor’s degree in biology, Microbiology, or Engineering.
• Minimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment.
• Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing.
• Experience with aseptic process simulations (media fills) including planning, execution, and approval.
• Proven experience in completing aseptic process validations and report generation.
• Ability to qualify and train manufacturing personnel in aseptic techniques and sterility assurance standards.
• Strong analytical and problem-solving skills with attention to detail.
• Good communication skills, able to clearly document and report findings.
• Effective project and time management skills.
• Ability to work collaboratively across multiple departments and influence stakeholders.

Nice To Haves

• Advanced degree preferred.
• Experience with sterile dosage forms manufacturing.
• Proficiency with electronic quality management systems (eQMS).
• Advanced degree in relevant scientific discipline.

Responsibilities

• Own and manage the sterility assurance program, including policies, procedures, and related documentation.
• Develop, implement, and maintain sterility assurance programs including sterilization validations, bioburden testing, endotoxin testing, and contamination control strategies.
• Lead cross-functional teams to assess sterility risks and develop mitigation plans.
• Oversee validation and monitoring of sterilization processes including aseptic processing, sterilizer cycles, and environmental controls.
• Own the planning, execution, and approval of aseptic process simulations (media fills) ensuring compliance with regulatory requirements and internal standards.
• Complete aseptic process validations, including protocol development, execution, data review, and final report generation.
• Ensure qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.
• Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.
• Ensure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.
• Collaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.
• Manage deviation investigations, root cause analysis, and CAPA related to sterility assurance issues.
• Conduct training and provide guidance on sterility assurance principles and best practices.
• Support regulatory inspections and audits, acting as the subject matter expert for sterility assurance.
• Monitor sterility assurance metrics and prepare reports for senior management.
• Stay updated with advances in sterility assurance technologies, regulatory changes, and industry best practices including Annex 1 revisions.

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs
• employee resource groups, volunteer paid time off, employee events, and charity drives
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level