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 , 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.