Scientist, Analytical R&D (Microbiologist)

Job Description

The Analytical Research and Development Microbiology group has an opening for a Scientist - Microbiologist. 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 your role as Scientist you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory including finished products testing utilities and environmental monitoring. While working within a fast-paced integrated multidisciplinary team environment the candidate is expected to have a strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. Prior Environmental Monitoring experience is a plus This position is based at the Rahway New Jersey site.

Primary Responsibilities

• Perform routine viable and nonviable Environmental Monitoring of classified cleanroom areas (Grad A-D) including surfaces air and equipment.

• Conduct active air passive air (settle plates) surface sampling in accordance with site EM programs and GMP requirements.

• Operate and maintain EM instruments (e.g. viable air samplers particle counters RODAC plates isolator/BSC environmental sampling tools).

• Execute aseptic sampling techniques to ensure data integrity and contaminationfree sample collection.

• Perform utility sampling/testing (WFI purified water clean steam) and support routine water system monitoring.

• Perform microbiology laboratory testing associated with EM samples including bioburden microbial identification and endotoxin testing.

• Trend analyze and interpret EM data; escalate atypical or outoftrend (OOT) results and support investigations.

• Participate in deviation investigations root cause assessments and CAPA development related to environmental or microbiological events.

• Maintain accurate documentation of sampling activities in compliance with ALCOA and dataintegrity principles.

• Conduct microbiology finished goods testing and biological indicator (BIs) testing

• Conduct the execution procedure results and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles

• Partner with internal stakeholders and partners including Quality Pipeline and Operations.

• Perform second scientist review microbiology experiments in line with GMP expectations

• Support internal and external compliance audit activities.

• Conduct other job duties as per management assignments/business requirement.

• Be flexible weekday work hours and weekend support as needed

Primary Skills:

• Adaptability

• Biological Sciences

• Environmental Monitoring

• GMP Compliance

• Good Manufacturing Practices (GMP)

• Laboratory Information Management System (LIMS)

• Laboratory Techniques

• Microbiological Tests

• Aseptic techniques

• Standard Operating Procedure (SOP)

• Interpersonal Relationship

• Self-Motivation

• Problem Solving

• Effective Communication

• Team Player

Education Minimum Requirements:

• BS degree in Microbiology or related Biological Sciences with 3 years of direct microbiological testing within GMP experience OR

• MS degree Microbiology or related Biological Sciences with 2 years of pharmaceutical industry experience

Required Experience and Skills

• A proven record of microbiology laboratory experience.

• Excellent written and oral communication skills.

• Strong interpersonal skills are necessary to qualify for this role.

• Knowledge and experience of microbiology testing in context of environmental monitoring aseptic manufacturing and utilities testing in a GMP environment.

• Knowledge of current microbiology industry guidelines and compendia.

Preferred Experience

• Knowledge in nonsterile and aseptic manufacturing and associated GMP product testing.

• Experience in supporting quality investigations in the microbiology discipline.

• Experience with MODA SAP Veeva LIMS is a plus.

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

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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