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

About the role

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 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.

Responsibilities

• 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.
• Analyze EM and water-system trends; identify hotspots, personnel-related risks, and systemic issues; recommend and implement risk-based mitigations on an ongoing basis.
• 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.
• 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.

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 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.
• 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.

Qualifications

• 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.

Skills

• Analytical Method 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