Associate Principal Scientist, Microbiology Testing, EM/Utilities Monitoring Program - Onsite/F[...]

Job Title Associate Principal Scientist – Microbiology Testing (EM / Utilities Monitoring Program – Onsite, First Shift) Location Rahway, NJ site Job Overview As part of a global team, you will collaborate with talented and dedicated colleagues while developing and expanding your career. 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. 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, 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 experience in risk‑based assessment, Environmental Monitoring Performance Qualification (EMPQ), Clean Utilities Monitoring, DE study and contamination control strategies is essential. 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 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 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 preventive 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. Extensive knowledge and experience of microbiology testing in the context of environmental monitoring program leadership – own and continuously improve the site EM program in alignment with EU GMP Annex 1 and 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 non‑sterile 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. Required Skills Analytical Method Development Assay Development Biological Assay Development Biological Sciences Cell‑Based Assays Chromatographic Techniques Contamination Control Cross‑Functional Teamwork Good Manufacturing Practices (GMP) High Resolution Mass Spectrometry (HRMS) Laboratory Information Management System (LIMS) Liquid Chromatography‑Mass Spectrometry (LC‑MS) Mass Spectrometry Analysis Microbiological Test Microbiology Process Analytical Technology (PAT) Protein Analysis Salary Range $142,400.00 - $224,100.00 Benefits 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. Equal Employment Opportunity and Legal Statements As an Equal Employment Opportunity Employer, 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 status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights EEOC GINA Supplement. We acknowledge and comply with local requirements: 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. #J-18808-Ljbffr MSD Malaysia