Sterility Assurance Program Manager

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.

Pay Range: $78,100.00 - $128,500.00

Position Summary

• 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.
• Key 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.

Qualifications

• 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.
• Education and Experience: Bachelor’s degree in biology, Microbiology, or Engineering. Advanced degree preferred.
• Minimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment.
• Knowledge, Skills, and Abilities: 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.
• Preferred Skills: Experience with sterile dosage forms manufacturing.
• Proficiency with electronic quality management systems (eQMS).
• Advanced degree in relevant scientific discipline.
• Working Conditions: Onsite work required in GMP manufacturing environments, laboratories, and controlled production areas.
• Exposure to biologics, chemicals, and standard bioprocessing equipment.
• Work may require standing, walking, or operating equipment for extended periods.
• May require occasional early hours or weekends based on production schedules.
• Physical Requirements: Ability to lift and move items up to 40–50 lbs.
• Ability to wear PPE required for clean room operations.
• Ability to maneuver equipment such as carts, cylinders, or supplies as needed.
• Extended periods of standing, walking, or working at production equipment and clean room environment.
• Extended periods sitting and performing computer work.

Why Join Bio-Techne

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
• Bio-Techne is an E-Verify Employer in the United States.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.