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**_ [_**[email protected]**_](mailto:[email protected]) _**for assistance.**_