Associate Principal Scientist, Microbiology AR&D (2nd Shift)

Merck•Rahway, NJ

6d•Onsite

About The Position

Join our global team and experience a culture of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As an Associate Principal Scientist on the Analytical Research and Development Microbiology team, you will be a key member 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, you will demonstrate strong proficiency in GMP microbiology laboratory practices, including microbiological data review, quality procedures, and compliance expectations. 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.

Requirements

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 and compendia
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.
Adaptability
Biological Sciences
Environmental Monitoring
GMP Compliance
Good Manufacturing Practices (GMP)
Laboratory Information Management System (LIMS)
Laboratory Techniques
Scientific leadership
Microbiological Tests
Aseptic techniques
Standard Operating Procedure (SOP)
Interpersonal Relationship
Self-Motivation
Problem Solving
Communications
Team Player

Nice To Haves

Experience with testing in clean room environments and Aseptic process validation preferred
Experience with MODA, SAP, Veeva, LIMS is a plus.
Analytical Method Development
Assay Development
Biological Assay Development
Biomedical Sciences
Cell-Based Assays
Chromatographic Techniques
Contamination Control
Cross-Functional Teamwork
External Collaboration
High Resolution Mass Spectrometry (HRMS)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Manufacturing Compliance
Mass Spectrometry Analysis
Optimism
Process Analytical Technology (PAT)

Responsibilities

Lead the 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, 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.
Drive experimental design, execution, and data interpretation of microbiology data.
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 any investigations associated with GMP testing 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 testing, 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.