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

Job Title

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

Rahway, NJ site

As part of a global team, you will collaborate with talented and dedicated colleagues while developing and expanding your career. In the role of Associate Principal Scientist, you will be a key member of the Analytical Research and Development Microbiology team, supporting a rapidly expanding pipeline through close collaboration with cross‑functional stakeholders. This role is responsible for generating and delivering critical microbiology data within a GMP laboratory setting, including finished product testing, utilities monitoring, and environmental monitoring.

• Lead the execution of microbiology finished product testing, utilities, and environmental monitoring program in GMP environment.
• Leverage QC microbiology expertise as a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological indicator challenge tests, method suitability, endotoxin, microbial enumeration, media / reagent quality control testing, mycoplasma.
• Directly contribute to experimental design of special studies in support of aseptic operations, execution, authoring and trend analysis of environmental monitoring and utilities trend reports.
• Strong experience in risk‑based assessment, Environmental Monitoring Performance Qualification (EMPQ), Clean Utilities Monitoring, DE study and contamination control strategies is essential.
• Experience with testing in clean room environments and Aseptic process validation preferred.
• Analyze EM and water‑system trends; identify hotspots, personnel‑related risks, and systemic issues; recommend and implement risk‑based mitigations on an ongoing basis.
• Oversee the execution, procedure, results, and conclusions of experiments in a detailed and organized manner 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 vaccines finished drug products.
• Troubleshoot and lead investigations, CAPAs, change controls associated with GMP testing/monitoring through active collaboration with cross‑functional project teams and/or Quality stakeholders; identify appropriate corrective and preventive actions.
• Partner with internal stakeholders and partners including Quality, Pipeline, and Operations.
• Supervise microbiology team, data entry, data review, equipment, lab inventory and author/approve reports and data summaries.
• Conduct project management and/or scientific oversight of studies performed at Contract Laboratories.
• Contribute expertise and creativity to the collective knowledge and aid in solving complex problems.
• Participate in internal and external compliance audit activities.
• Perform additional duties as assigned.

Minimum Requirements:

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

• A proven record of strong technical problem solving and laboratory experience.
• Excellent written and oral communication skills, as well as interpersonal skills.
• Extensive knowledge and experience of microbiology testing in the context of environmental monitoring program leadership – own and continuously improve the site EM program in alignment with EU GMP Annex 1 and internal standards.
• Design and justify risk‑based EM strategies (locations, frequencies, methods) and ensure integration of EM into the Contamination Control Strategy (CCS).
• Oversee EM lifecycle activities, including EMPQ, requalification and periodic review.
• Lead EM data trending and statistical evaluation (e.g., MODA or equivalent systems).
• Identify emerging risk, low‑level trends, and adverse patterns.
• Extensive knowledge and experience of microbiology testing in aseptic manufacturing, and finished product testing…