Sterility Assurance Program Manager

Scorpion Therapeutics; Minnesota; On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Sterility Assurance Program Manager to design, implement, and continuously improve the sterility program in a GMP manufacturing environment. You will oversee policies, testing programs, and process validations to ensure product sterility and regulatory readiness.

You will lead cross-functional risk assessments, CAPA investigations, and training of manufacturing personnel in aseptic techniques while coordinating with QA, QC, and regulatory teams to

Qualifications

• Strong knowledge of aseptic processing, sterilization, contamination control, and microbiological testing.
• Experience qualifying/training manufacturing personnel and owning aseptic process validations.
• Familiarity with EU GMP Annex 1, FDA cGMP, EMA, USP, ISO 13485.
• Proven risk management experience (FMEA, HACCP) and solid documentation skills.

Responsibilities

• Own and manage sterility assurance policies, procedures, and documentation.
• Develop/maintain programs for sterilization validations, bioburden, endotoxin testing, and contamination control.
• Lead cross-functional sterility risk assessments and mitigation plans.
• Oversee sterilization/aseptic process validation and environmental controls.
• Plan, execute, and approve media fills and aseptic simulations.
• Complete aseptic process validations from protocol to report.
• Qualify and train personnel in aseptic technique and sterility requirements.
• Produce technical reports for internal review and regulatory submissions.
• Ensure compliance with FDA/EMA/ISO/USP and EU GMP Annex 1.
• Lead deviation investigations, root cause analysis, and CAPAs.
• Support regulatory inspections as SME; monitor sterility metrics.

Skills

Aseptic processing

Sterilization

Contamination control

Microbiological testing

Media fills

Process validations

Training manufacturing personnel

Aseptic process validations

Regulatory familiarity (FDA/EMA/ISO)

Risk management (FMEA/HACCP)

Documentation & reporting

Education

Bachelor’s in Biology, Microbiology, or Engineering

Advanced degree preferred

Tools

eQMS

Job description

Position Summary

The Sterility Assurance Program Manager develops, implements, oversees, and continuously improves the sterility assurance program in a GMP-regulated manufacturing environment to ensure product sterility.

Key Responsibilities

• Own and manage sterility assurance policies, procedures, and documentation.
• Develop/maintain programs covering sterilization validations, bioburden testing, endotoxin testing, and contamination control.
• Lead cross-functional sterility risk assessments and mitigation plans.
• Oversee sterilization/aseptic process validation and environmental controls.
• Plan, execute, and approve aseptic process simulations (media fills).
• Complete aseptic process validations (protocols, execution, data review, reports).
• Qualify and train manufacturing personnel in aseptic technique, contamination control, and sterility requirements.
• Produce technical reports for internal review and regulatory submissions.
• Ensure compliance with applicable regulations/standards (FDA/EMA/USP/ISO; EU GMP Annex 1).
• Lead deviation investigations, root cause analysis, and CAPA.
• Support regulatory inspections/audits as SME; monitor and report sterility metrics.

Qualifications

• Strong knowledge of aseptic processing, sterilization, contamination control, microbiological testing, media fills, and process validations.
• Experience qualifying/training manufacturing personnel.
• Experience owning/executing/reporting aseptic process validations.
• In-depth knowledge of EU GMP Annex 1; familiarity with FDA cGMP, EMA, USP, ISO 13485.
• Risk management experience (e.g., FMEA, HACCP).
• Analytical, problem-solving, project management, and documentation skills.

Education/Experience

• Bachelor’s in Biology, Microbiology, or Engineering (advanced degree preferred).
• 5+ years in sterility assurance/quality assurance in GMP manufacturing.

Preferred Skills

• Sterile dosage form manufacturing; eQMS proficiency; advanced degree.