BioTechne

Sterility Assurance Program Manager

BioTechne • $78K — $128K *
St. Paul, MN 55106In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Strong expertise in aseptic processing, sterilization, and contamination control methods.
  • 5+ years in sterility assurance or related quality assurance roles within GMP settings.
  • Demonstrated experience in leading cross-functional teams for sterility risk assessments.
  • In-depth knowledge of EU GMP Annex 1 and relevant regulatory requirements.
  • Proven ability to manage and report on aseptic process validations.
  • Competence in risk management methodologies and tools (e.g., FMEA).
  • Excellent analytical and problem-solving capabilities.

Responsibilities

  • Own and manage the sterility assurance program for the organization.
  • Develop and implement sterility assurance programs and validation processes.
  • Lead teams to identify sterility risks and create mitigation strategies.
  • Oversee monitoring of sterilization processes and environmental controls.
  • Plan and execute aseptic process simulations ensuring compliance with regulatory standards.
  • Generate detailed reports regarding sterility assurance activities for review.
  • Train manufacturing staff on aseptic techniques and sterility requirements.

Benefits

  • Opportunities for career development and growth within a regulated environment.
  • Ability to work in a collaborative, cross-functional team atmosphere.
  • Involvement in cutting-edge sterility assurance technologies and practices.
  • Support during regulatory audits and inspections as a subject matter expert.
  • Onsite experience in a state-of-the-art GMP manufacturing facility.
Full Job Description


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.

About BioTechne

Bio-Techne Corporation develops, manufactures, and sells life sciences tools, diagnostics, and reagents worldwide. The company operates in three segments: Protein Sciences, Diagnostics and Genomics, and Clinical Controls. The Protein Sciences segment offers proteins and reagent solutions, including cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, and T-Cell activation technologies. The Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, diagnostic immunoassays, and other bulk and custom reagents for the in vitro diagnostic market. The Clinical Controls segment offers a range of products comprising Thrombin Generation Assays, and quality controls and calibrators for various clinical instruments. The company was founded in 1976 and is headquartered in Minneapolis, Minnesota.
Learn more about BioTechne
Size
2,600 employees
Market Cap
$12.9 billion
Industry
Pharmaceuticals & Biotech
Net Income
$174.9 million
Founded
1981
5 Year Trend
+14.5%
Revenue
$798.9 million
NASDAQ
TECH
* Ladders Estimates

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