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

Senior Scientist – Microbiologist

Analytical Research and Development Microbiology group has an opening for a Senior 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 Senior Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including supporting 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.

In this role, you will be accountable for building and sustaining a scientifically sound, risk‑based, and inspection‑ready microbiology program by integrating Environmental Monitoring and Product Testing into a comprehensive contamination control strategy.

This position is based at the Rahway, New Jersey site.

Primary Responsibilities:

• Support and execution of microbiology finished product testing, utilities, and environmental monitoring 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, and method suitability, endotoxin, microbial enumeration, media / reagent quality control testing.
• Experience with testing in clean room environments and Aseptic process validation preferred.
• 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.
• Document 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 any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders.
• Identify appropriate corrective and preventative actions.
• Collaborate with internal stakeholders and partners including Quality, Pipeline, and Operations and provide training to the staff.
• Perform microbiology testing and studies, data entry, data review, and author analytical reports and data summaries.
• Conduct project management and/or scientific oversight of studies and samples performed at Contract Laboratory Organizations
• Contribute expertise and creativity to the collective knowledge and aid in solving complex problems.
• Support internal and external compliance audit activities.
• Perform additional duties as assigned.

Education Minimum Requirements:

• Degree in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience.
• PhD degree with 1+ years of pharmaceutical industry experience or
• MS degree with 4+ years of experience or
• BS degree with 7+ years of experience

Required Experience and Skills:

• A proven record of strong technical problem solving and laboratory experience.
• Excellent written and oral communication skills.
• Interpersonal skills are necessary for this role.
• Extensive knowledge and experience of microbiology testing in context of environmental monitoring, sterile operations, and finished product testing in a GMP environment.
• Knowledge and experience with nonsterile and sterile manufacturing and associated GMP product testing.
• Experience in leading and supporting quality investigations in the microbiology discipline.
• Experience with internal / external audit process and authoring responses to observations.
• Knowledge of current microbiology industry guidelines and compendia.

Preferred Experience and Skills:

• Experience with MODA, SAP, Veeva.
• Experience with testing in clean room environments.
• Aseptic process validation.

Required Skills: Environmental Monitoring, GMP Environments, Microbiological Test, Microbiology, Microbiology Laboratory, QC Microbiology, Quality Investigations, Technical Problem-Solving

Preferred Skills: