Sterility Assurance Lead — GMP Manufacturing Excellence

Bio-Techne Corp.; Saint Paul (MN); On-site; USD 78,000 - 129,000; Full time

Benefits offered by this job

Healthcare benefits

401k with ESPP

Tuition reimbursement

Job summary

Bio-Techne Corp. is seeking a Sterility Assurance Program Manager to lead the sterility program in a GMP manufacturing environment. You will own policies, validations, testing, and contamination control while guiding cross‑functional teams to mitigate sterility risks.

The role requires deep knowledge of aseptic processing, sterile dosing, and regulatory requirements (FDA/EMA/ISO). Onsite work in a bio/pharma manufacturing setting with strong emphasis on quality and continuous improvement.

Qualifications

• Bachelor’s degree in biology, microbiology, or engineering with at least 5 years in sterility assurance in GMP manufacturing.
• Strong knowledge of aseptic processing, sterilization, and contamination control.
• Experience with aseptic process validations, media fills, and regulatory compliance.
• Familiarity with EU GMP Annex 1, FDA cGMP, EMA, USP, ISO 13485.

Responsibilities

• Own and manage the sterility assurance program including policies, procedures, and documentation.
• Develop and maintain programs for sterilization validations, bioburden, endotoxin testing, and contamination control.
• Lead cross‑functional teams to assess sterility risks and mitigation plans.
• Oversee validation and monitoring of sterilization processes and aseptic cycles.
• Plan, execute, and approve aseptic process simulations (media fills) per regulatory standards.
• Complete aseptic process validations with protocol development, data review, and final reports.
• Qualify and train manufacturing personnel in aseptic techniques and sterility requirements.
• Prepare technical reports for regulatory submissions and internal reviews.

Skills

aseptic processing

sterilization methods

contamination control

microbiological testing

media fills

process validations

FMEA

HACCP

project management

regulatory knowledge

communication

Education

Bachelor's degree in biology, microbiology, or engineering

Advanced degree preferred

Tools

eQMS

Job description

Bio-Techne Corp. is seeking a Sterility Assurance Program Manager to lead the sterility program in a GMP manufacturing environment. You will own policies, validations, testing, and contamination control while guiding cross‑functional teams to mitigate sterility risks.

The role requires deep knowledge of aseptic processing, sterile dosing, and regulatory requirements (FDA/EMA/ISO). Onsite work in a bio/pharma manufacturing setting with strong emphasis on quality and continuous improvement.