Associate Principal Scientist, Microbiology Testing, EMUtilities Monitoring Program – OnsiteFirst Shift

Job Description

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

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 crossfunctional 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 fastpaced 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 riskbased and inspectionready 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:

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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 employees 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 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

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