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

Merck & Co. • West Point, PA

35d • Onsite

About The Position

The Analytical Research and Development Microbiology group has an opening for a Senior 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 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 product, raw material, rapid method testing. 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 West Point, Pennsylvania site.

Requirements

• Minimum 1 years of pharmaceutical industry experience for applicants with a PhD degree; 4 years of experience with a MS degree, or 7 years of experience with a BS in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience.
• 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 sterile operations, and finished product, intermediate and or raw material bioburden testing in a GMP environment
• Knowledge and experience with 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 and compendia
• Accountability
• Adaptability
• Analytical Method Development
• Assay Development
• Bioanalytical Analysis
• Biochemical Assays
• Cell-Based Assays
• Chromatographic Techniques
• Communication
• GMP Environments
• Innovative Thinking
• Nuclear Magnetic Resonance (NMR) Analysis
• Process Analytical Technology (PAT)
• Strategic Thinking
• Team Management
• Technical Writing
• Ultra Performance Liquid Chromatography (UPLC)

Responsibilities

• Support and execution of microbiology finished product and raw material testing, in a GMP environment
• Apply QC microbiology expertise as a subject matter expert in support of sterile operations within the quality control department including, sterility, endotoxin and microbial enumeration testing.
• Directly contribute to experimental design of special studies in support of operations.
• Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles
• Execute test method suitability studies and implement microbiology methods to support release and stability testing of biologics, and vaccines finished drug products.
• Troubleshoot and lead any investigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.
• Collaborate with internal stakeholders and partners including Quality, Pipeline, and Operations.
• Perform microbiology testing and studies, data entry, data review, and author analytical reports and data summaries.
• Contribute expertise and creativity to the collective knowledge and aid in solving complex problems.
• Support internal and external compliance audit activities.

Benefits

• 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 https://jobs.merck.com/us/en/compensation-and-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees