Scientist, Analytical R&D (Microbiologist) Full-time

Scientist – Microbiologist

The Analytical Research and Development Microbiology group has an opening for a Scientist – Microbiologist. Join us and experience our culture first-hand one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In your role as Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory, including finished products testing, utilities, and environmental monitoring. While working within a fast-paced, integrated, multidisciplinary team environment, the candidate is expected to have a strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. Prior Environmental Monitoring experience is a plus This position is based at the Rahway, New Jersey site. This position is a 2nd Shift schedule.

Primary Responsibilities

• Perform routine viable and non-viable Environmental Monitoring of classified cleanroom areas (Grad A-D), including surfaces, air, and equipment.
• Conduct active air, passive air (settle plates), surface sampling, in accordance with site EM programs and GMP requirements.
• Operate and maintain EM instruments (e.g., viable air samplers, particle counters, RODAC plates, isolator/BSC environmental sampling tools).
• Execute aseptic sampling techniques to ensure data integrity and contamination-free sample collection.
• Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring.
• Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.
• Trend, analyze, and interpret EM data; escalate atypical or out-of-trend (OOT) results and support investigations.
• Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events.
• Maintain accurate documentation of sampling activities in compliance with ALCOA and data-integrity principles.
• Conduct microbiology finished goods testing and biological indicator (BIs) testing
• Support of sterile operations within the quality control department including utilizing isolator for sterility testing, conduct method suitability testing, endotoxin, microbial enumeration, media / reagent quality control testing, Experience with testing in clean room environments preferred
• Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles
• Partner with internal stakeholders and partners, including Quality, Pipeline, and Operations.
• Perform second scientist review microbiology experiments in line with GMP expectations
• Support internal and external compliance audit activities.
• Conduct other job duties as per management assignments/business requirement.
• Be flexible weekday work hours and weekend support as needed

Education Minimum Requirements:

• BS Degree with 3+ years of pharmaceutical industry experience, with direct microbiological testing GMP experience.
• MS Degree with 2+ years of pharmaceutical industry experience, with direct microbiological testing GMP experience.
• Degree in Microbiology or related Biological Sciences, or equivalent.

Required Experience and Skills

• A proven record of microbiology laboratory experience.
• Excellent written and oral communication skills.
• Interpersonal skills, are necessary to qualify for this role.
• Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and utilities testing in a GMP environment
• Knowledge of current microbiology industry guidelines and compendia

Preferred Experience

• Knowledge in sterile, nonsterile and aseptic manufacturing and associated GMP product testing
• Experience in supporting quality investigations in the microbiology discipline
• Experience with MODA, SAP, Veeva, LIMS is a plus.

Required Skills:

Biological Sciences, Biomedical Sciences, Data Integrity, Deviation Investigations, Environmental Monitoring, Fast-Paced Environments, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Laboratory Techniques, Microbiological Test, Problem Solving

Preferred Skills: