Associate Principal Scientist, Microbiology Testing, EM​/Utilities Monitoring Program - Onsite​/F

Associate Principal Scientist – Microbiology Testing, EM /Utilities Monitoring Program (First Shift)

Join us and experience our culture of strong ethics and integrity. You will work with a global team of dedicated scientists, collaborating across functions and advancing your career while contributing to human health.

The Associate Principal Scientist will play a key role in the Analytical Research and Development Microbiology team, supporting a rapidly expanding pipeline. This position is responsible for generating and delivering critical microbiology data within a GMP laboratory setting, including finished product testing, utilities monitoring, and environmental monitoring.

The role is based at the Rahway, NJ site.

• Lead the execution of microbiology finished product testing, utilities, and environmental monitoring program in a GMP environment.
• Leverage QC microbiology expertise as a subject‑matter expert in support of sterile operations, including isolator qualifications, sterility testing, biological indicator challenge tests, method suitability, endotoxin, microbial enumeration, media/reagent quality control testing, and mycoplasma.
• Directly contribute to experimental design of special studies for aseptic operations; execute, author, and analyze environmental monitoring and utilities trend reports.
• Apply risk‑based assessment for Environmental Monitoring Performance Qualification (EMPQ), Clean Utilities Monitoring, DE study, and contamination control strategies.
• Analyze EM and water‑system trends to identify hotspots, personnel‑related risks, and systemic issues; recommend and implement ongoing risk‑based mitigations.
• Oversee the execution, procedure, results, and conclusions of experiments following ALCOA and data integrity principles.
• Execute test method suitability studies and implement microbiology methods to support release and stability testing of small molecule, biologic, and vaccine finished drug products.
• Troubleshoot and lead investigations, CAPAs, and change controls associated with GMP testing/monitoring through active collaboration with cross‑functional project teams and Quality stakeholders.
• Partner with internal stakeholders and external partners including Quality, Pipeline, and Operations.
• Supervise microbiology team, data entry, data review, equipment, lab inventory, and approve reports and data summaries.
• Conduct project management and scientific oversight of studies performed at contract laboratories.
• Contribute expertise and creativity to the collective knowledge and assist in solving complex problems.
• Participate in internal and external compliance audit activities.
• Perform additional duties as assigned.
• Lead EM data trend analysis.

• Minimum 4 years of pharmaceutical industry experience for applicants with a PhD degree.
• 8 years of experience for applicants with an MS degree.
• 12 years of experience for applicants with a BS in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience.

• Proven record of strong technical problem solving and laboratory experience.
• Excellent written and oral communication skills, as well as interpersonal skills.
• Extensive knowledge of microbiology testing in the context of environmental monitoring program leadership.
• Experience designing and justifying risk‑based EM strategies (locations, frequencies, methods) and ensuring integration of EM into the Contamination Control Strategy (CCS).
• Oversight of EM lifecycle activities, including EMPQ, requalification and periodic review.