Quality Control Environmental Monitoring Scientist II

Scorpion Therapeutics

New Hampshire

On-site

USD 140,000 - 190,000

Full time

10 days ago
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Job summary

Novo Nordisk is seeking a Subject Matter Expert in industrial/pharmaceutical Environmental Monitoring at its manufacturing site, primarily overseeing microbiological control and compliance programs.

The role requires leadership in environmental monitoring, risk assessment, and cross-functional collaboration for investigations and qualification activities, with minimal travel and strong regulatory adherence.

Qualifications

  • Bachelor’s in microbiology or related field with a minimum of 8 years’ experience in biopharma manufacturing.
  • Proven leadership in environmental monitoring, project management, and microbiology techniques is required.

Responsibilities

  • Lead the site EM program and oversee aseptic contamination controls.
  • Conduct risk assessments and support audits.
  • Handle deviations and CAPAs; review data and trending reports.
  • Support investigations, qualification activities, and EM program setup.

Skills

Environmental monitoring
GMP compliance
Microbiology techniques
Project management
Leadership

Education

Bachelor's in microbiology or related field
Advanced degree preferred

Job description

Role

Subject Matter Expert in industrial/pharmaceutical Environmental Monitoring at Novo Nordisk’s manufacturing site, primarily overseeing microbiological control and compliance programs.

Responsibilities

Responsibilities include leading the site EM program, managing aseptic contamination controls, conducting risk assessments, supporting audits, handling deviations and CAPAs, and reviewing data/trending reports.

The role demands technical expertise in microbiology, GMP compliance, and cross-functional collaboration for support on EM program setup, investigations, and qualification activities.

Qualifications

Qualifications: Bachelor’s in microbiology or related field with a minimum of 8 years’ experience in biopharma manufacturing; advanced degrees preferred with fewer years of experience.
Proven leadership in environmental monitoring, project management, and microbiology techniques is required.

High-Value

High-Value: Focus on aseptic processes, microbiological assays, GMP, and compliance in a biologics manufacturing environment.

Physical Demands

Physical demands include site inspections and working in diverse environments, with minimal travel (~0-10%).

The role involves independent judgment, technical mentoring, and ensuring adherence to regulatory standards.

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