Scientist, Analytical R&D (Microbiologist) - Onsite
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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. This position is based at the Rahway, New Jersey site.
Primary Responsibilities
Conduct microbiology finished
Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principals
Execute microbiology suitability studies to support release and stability testing of small molecule, biologic, and vaccines finished drug products.
Participate in investigations associated with GMP testing through active partnership
Partner with internal stakeholders and partners including Quality, Pipeline, and Operations.
Second scientist review microbiology experiments in line with GMP expectations
Support internal and external compliance audit activities.
Education Minimum Requirements:
Minimum 3 years of pharmaceutical industry experience for applicants with a BS degree; 0-2 years of experience with a MS degree Microbiology or related Biological Sciences, or equivalent with direct microbiological testing experience.
Required Experience and Skills
A proven record of microbiology laboratory experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.
Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and finished product 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
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