Sr. Scientist, Analytical R&D- Microbiologist (Onsite) Full-time

Senior Scientist

As Senior Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including supporting 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. This position is based at the Rahway, New Jersey site.

In this role, you will be accountable for building and sustaining a scientifically sound, risk-based, and inspection-ready microbiology program by integrating Environmental Monitoring, Utilities monitoring and Product Testing into a comprehensive contamination control strategy (CCS). This position is based at the Rahway, NJ site.

Primary Responsibilities:

• Schedule, plan and lead the execution of environmental monitoring (EM), utilities monitoring, and microbiological testing activities in GMP Microbiology laboratory.
• Provide QC microbiology expertise as a subject matter expert in support of sterile/nonsterile operations within the Micro department including testing in clean room environments, Aseptic process validation, isolator qualifications, biological indicator challenge tests, Bioburden, endotoxin, microbial enumeration, media / reagent growth promotion testing.
• Manage the environmental monitoring program for the site including risk assessment, sampling locations, frequencies, alert and action limits through to routine viable and non-viable sampling, testing, and EM trend reports.
• Establishes/oversee environmental monitoring of utilities and compressed gases, including the sampling strategies, equipment, and procedure, and verified performance before routine use.
• Led EM excursions investigation, deviations, and out-of-trend results. Identify root cause, document findings in the investigation record, drive CAPA and change control to closure.
• Design and execute special studies in support of aseptic operations and author environmental monitoring and utilities trend reports.
• Support/Lead aseptic process simulation and aseptic process validation activities including the EM sampling strategy
• Document the executions, procedure, results, and conclusions of microbiological testing in a detailed and organized manner following ALCOA+ and data integrity principles
• Troubleshoot and lead investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify and implement appropriate corrective and preventative actions.
• Collaborate with internal stakeholders and partners including Quality, Engineering, validation, automations, and Operations.
• Perform second scientist review (SSR) and provide training to the staff.
• Apply lean and six Sigma to laboratory process improvement and site expansion initiatives.
• Contribute scientific expertise, technical leadership and creativity problem solving to strengthen the collective capability of Microbiology organization.
• Support internal and external compliance audit activities.
• Perform additional duties as assigned.

Education Minimum Requirements:

• Degree in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience.
• BS Degree with 7+ years of pharmaceutical industry experience OR
• MS Degree with 4+ years of pharmaceutical industry experience OR
• Ph.D. Degree with 1+ years of pharmaceutical industry 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, utilities monitoring, microbiological testing and finished product testing in a GMP environment.
• Oversee EM lifecycle activities, including EMPQ, requalification and periodic review.
• Knowledge and experience with nonsterile and sterile 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 guidances and USP compendia.
• Experience with MODA, SAP, Veeva is a plus.

Required Skills:

Environmental Monitoring, GMP Compliance, Good Manufacturing Practices (GMP), Interpersonal Relationships, Laboratory Experiments, Microbiology, Problem Solving, Process Ownership

Preferred Skills:

Aseptic Operations, GMP Documentation, Microbiology Laboratory