Senior Environmental Monitoring Scientist – EM Program Lead

BioSpace

West Lebanon (NH)

On-site

USD 110,000 - 160,000

Full time

29 hours ago
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Job summary

Novo Nordisk’s New Hampshire site in West Lebanon seeks a subject matter expert in Environmental Monitoring to align facility programs with industry and regulatory practices. This senior role demands independence, matrix leadership, and a strong focus on GMP compliance while guiding EM strategy and data review.

The candidate will lead area monitoring, collaborate across functions, and drive investigations, CAPAs, and SOP improvements, ensuring quality and patient safety in every activity.

Qualifications

  • Bachelor’s degree with a minimum of eight (8) years in the pharmaceutical/biotech industry
  • Master’s degree with a minimum of six (6) years in the pharmaceutical/biotech industry
  • PhD degree with a minimum of two (2) years in the pharmaceutical/biotech industry
  • Three (3) years of experience in project management activities and cross functional team coordination
  • Desirable to have a minimum two (2) years of experience in a lead role within a biotech/pharmaceutical environmental monitoring program
  • Demonstrated ability to manage development associate staff

Responsibilities

  • Site lead for the Environmental Monitoring program at site NNUSBPI.
  • Technical subject matter expert on microbiological assays, techniques and industry practices
  • Participates in site audits and inspections; responsible for area monitoring
  • High degree of understanding with respect to GMP and compliance; distill recommendations into actionable plans
  • Collaborates cross functionally to provide EM support and data review
  • Leads training and education on basic microbiology and aseptic behaviour
  • Responsible for protocol and report generation to support area monitoring facility qualification
  • Organizes and reviews EM trending data and writes reports summarizing trends
  • Handles major deviations, CAPA investigations and corrective actions.
  • Investigates and resolves issues related to assay failures and system deficiencies
  • Reviews/updates test method and program SOPs as needed
  • Creates methods and procedures on new assignments as required
  • Performs all job duties in a compliant and ethical manner and in line with healthcare laws
  • Incorporates Novo Nordisk Way and 10 Essentials in all activities
  • Other duties as assigned

Skills

Microbiology expertise
GMP compliance
Leadership
Project management
Audit readiness
Cross-functional collaboration
SOP writing/updates

Education

Bachelor’s in microbiology
Master’s in microbiology
PhD in microbiology

Job description

Novo Nordisk’s New Hampshire site in West Lebanon seeks a subject matter expert in Environmental Monitoring to align facility programs with industry and regulatory practices. This senior role demands independence, matrix leadership, and a strong focus on GMP compliance while guiding EM strategy and data review.

The candidate will lead area monitoring, collaborate across functions, and drive investigations, CAPAs, and SOP improvements, ensuring quality and patient safety in every activity.

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