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

Job description

Job Description Job Description: 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: This role is responsible for building and sustaining a scientifically robust, risk based, and inspection ready EM/Utilities program, integrating Environmental Monitoring and Product Testing into a comprehensive contamination control strategy. 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. #AR&D 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 Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $117,000.00 - $184,200.00 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 employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (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 complian