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

Merck; Rahway (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Merck & Co., Rahway, NJ, is seeking a Senior Scientist to join the Analytical Research and Development Microbiology team. You will support GMP microbiology labs, including finished products testing, utilities monitoring, and environmental monitoring within a fast-paced, cross-functional setting.

You will build a robust, risk-based contamination control strategy and lead EM lifecycle activities with emphasis on data integrity and ALCOA+ principles.

Qualifications

• Strong microbiology lab experience in GMP environments.
• Experience with EM/Utilities monitoring and product testing.
• Experience leading investigations and CAPA in QA contexts.
• Knowledge of regulatory guidelines and USP where applicable.

Responsibilities

• Schedule and lead environmental monitoring and microbiological testing in GMP lab.
• Provide QC microbiology expertise for sterile and non-sterile operations.
• Manage EM program including sampling, data review and trend reports.
• Lead investigations, root-cause analysis and CAPA closure.
• Collaborate with Quality, Engineering, validation and Operations.

Skills

Environmental Monitoring

GMP Compliance

Microbiology

Problem Solving

Interpersonal Skills

Education

Bachelor's degree in Microbiology / related field

7+ years pharma industry with BS

MS with 4+ years pharma

PhD with 1+ year pharma

Tools

MODA

SAP

Veeva

Job description

Job Description

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

Job Description

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. This position is based at the Rahway, NJ site.

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, Utilities monitoring and Product Testing into a comprehensive contamination control strategy (CCS). This position is based at the Rahway, NJ site.

Primary Responsibilities

• Schedule, plan and lead the execution of environmental monitoring (EM), utilities monitoring, and microbiological testing activities in GMP Microbiology laboratory.
• Provide QC microbiology expertise as a subject matter expert in support of sterile/nonsterile operations within the Micro department including testing in clean room environments, Aseptic process validation, isolator qualifications, biological indicator challenge tests, Bioburden, endotoxin, microbial enumeration, media / reagent growth promotion testing.
• Manage the environmental monitoring program for the site including risk assessment, sampling locations, frequencies, alert and action limits through to routine viable and non-viable sampling, testing, and EM trend reports.
• Establishes/oversee environmental monitoring of utilities and compressed gases, including the sampling strategies, equipment, and procedure, and verified performance before routine use.
• Led EM excursions investigation, deviations, and out-of-trend results. Identify root cause, document findings in the investigation record, drive CAPA and change control to closure.
• Design and execute special studies in support of aseptic operations and author environmental monitoring and utilities trend reports.
• Support/Lead aseptic process simulation and aseptic process validation activities including the EM sampling strategy
• Document the executions, procedure, results, and conclusions of microbiological testing in a detailed and organized manner following ALCOA+ and data integrity principles
• Troubleshoot and lead investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify and implement appropriate corrective and preventative actions.
• Collaborate with internal stakeholders and partners including Quality, Engineering, validation, automations, and Operations.
• Perform second scientist review (SSR) and provide training to the staff.
• Apply lean and six Sigma to laboratory process improvement and site expansion initiatives.
• Contribute scientific expertise, technical leadership and creativity problem solving to strengthen the collective capability of Microbiology organization.
• 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.
• BS Degree with 7+ years of pharmaceutical industry experience OR
• MS Degree with 4+ years of pharmaceutical industry experience OR
• Ph.D. Degree with 1+ years of pharmaceutical industry experience.

Required Experience And Skills

• A proven record of strong technical problem solving and laboratory experience.
• Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.
• Extensive knowledge and experience of microbiology testing in context of, environmental monitoring, utilities monitoring, microbiological testing and finished product testing in a GMP environment.
• Oversee EM lifecycle activities, including EMPQ, requalification and periodic review.
• 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, regulatory guidances and USP compendia.
• Experience with MODA, SAP, Veeva is a plus.

#AR&D

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 09/21/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R416586

Required Skills

Environmental Monitoring, GMP Compliance, Good Manufacturing Practices (GMP), Interpersonal Relationships, Laboratory Experiments, Microbiology, Problem Solving, Process Ownership

Preferred Skills

Aseptic Operations, GMP Documentation, Microbiology Laboratory

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Requirements

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