Job Description

R4, Associate Principal Scientist – Microbiology Testing, EM /Utilities  Monitoring Program – Onsite (First Shift)

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.

Working within a fast‑paced, integrated, and multidisciplinary environment, the Associate Principal Scientist is expected to demonstrate strong proficiency in GMP microbiology laboratory practices, including microbiological data review, quality procedures, and compliance expectations.

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, NJ site.

Primary Responsibilities

• 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, and 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 experiences in risk-based assessment, Environmental Monitoring Performance Qualification (EMPQ), Clean Utilities Monitoring, DE study and contamination control strategies is essential. These skills ensure robust identification and mitigation of potential risks, as well as the implementation of comprehensive monitoring and preventive measures to maintain product integrity and regulatory compliance.

• 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 principle.

• 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 preventative 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.

Education 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.

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 program leadership – own and continuously improve the site EM program in alignment with EU GMP Annex 1and 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 in a GMP environment

• Translate microbiological data into proactive risk mitigation actions

• Expertise in nonsterile and aseptic 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 guidance documents and compendia

• Experience with MODA, SAP, Veeva, LIMS is a plus.

Leadership

• Demonstrated ability to mentor, guide, and develop laboratory staff, fostering a collaborative and high-performance work environment.

• Proven experience in managing cross-functional teams and coordinating microbiology projects to meet deadlines and quality standards and ensuring teams meet timelines / deliverables.

• Strong decision-making skills and the capacity to lead by example, ensuring compliance with regulatory requirements and company policies.

This role is responsible for building and sustaining a scientifically robust, risk based, and inspection ready microbiology /EM/Utilities program, integrating Environmental Monitoring and Product Testing into a comprehensive contamination control strategy.

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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