Scientist, Analytical R&D

R2 Scientist, Analytical R&D (Microbiologist) – Onsite (Second Shift)

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.

• 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. Inventory management.
• 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 of 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.

• Minimum 2 years of pharmaceutical industry experience for applicants with a MS degree or
• 3 years of experience for BS degree in Microbiology or related Biological Sciences, or equivalent with direct microbiological testing GMP experience.

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

• 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.

Salary range: $87,300.00 – $. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, healthcare and other insurance benefits for employee and family, retirement benefits including a 401(k), paid holidays, vacation, and compassionate and sick days.

We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran…