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Sr. Scientist, Analytical R&D- Microbiologist (Onsite)

Merck · Rahway, NJ

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ResearchFull-time$117k–$184kCompany career page

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Role summary

Senior Scientist in Analytical R&D Microbiology supporting Merck's pharmaceutical pipeline through GMP microbiology testing, environmental monitoring, and contamination control strategy development at the Rahway, New Jersey facility.

What they're looking for

  • BS in Microbiology or related biological sciences with 7+ years pharmaceutical industry experience
  • MS degree with 4+ years pharmaceutical industry experience, or PhD with 1+ year
  • Extensive GMP microbiology experience including environmental monitoring, utilities monitoring, and finished product testing
  • Demonstrated technical problem-solving and laboratory expertise with strong written and oral communication
  • Knowledge of sterile and nonsterile manufacturing, aseptic operations, and current regulatory guidelines
  • Experience leading quality investigations, audits, and environmental monitoring lifecycle activities

What you'll be doing

  • Build and sustain scientifically sound, risk-based environmental monitoring and utilities programs integrated with product testing
  • Schedule, plan, and lead environmental monitoring, utilities monitoring, and microbiological testing activities in GMP laboratory
  • Manage site environmental monitoring program including risk assessment, sampling strategies, alert/action limits, and trend reporting
  • Lead investigations of EM excursions, deviations, and out-of-trend results; identify root causes and drive corrective actions
  • Support aseptic process validation and simulation activities; design special studies and perform second scientist review

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