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

Job description

Job Description Job Description 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 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. 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 and Product Testing into a comprehensive contamination control strategy. This position is based at the Rahway, New Jersey site. Primary Responsibilities: Support and execution of microbiology finished product testing, utilities, and environmental monitoring in GMP environment. Leverage QC microbiology expertise as a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological indicator challenge tests, and method suitability, endotoxin, microbial enumeration, media / reagent quality control testing. Experience with testing in clean room environments and Aseptic process validation preferred. Directly contribute to experimental design of special studies in support of aseptic operations, execution, authoring and trend analysis of environmental monitoring and utilities trend reports. 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 small molecule, biologic, 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 and provide training to the staff. Perform microbiology testing and studies, data entry, data review, and author analytical reports and data summaries. Conduct project management and/or scientific oversight of studies and samples performed at Contract Laboratory Organizations Contribute expertise and creativity to the collective knowledge and aid in solving complex problems. 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. PhD degree with 1+ years of pharmaceutical industry experience or MS degree with 4+ years of experience or BS degree with 7+ years of experience Required Experience and Skills: A proven record of strong technical problem solving and laboratory experience. Excellent written and oral communication skills. Interpersonal skills are necessary for this role. Extensive knowledge and experience of microbiology testing in context of environmental monitoring, sterile operations, and finished product testing in a GMP environment. 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 and compendia. Preferred Experience and Skills: Experience with MODA, SAP, Veeva. Experience with testing in clean room environments. Aseptic process validation. #AR&D Required Skills: Environmental Monitoring, GMP Environments, Microbiological Test, Microbiology, Microbiology Laboratory, QC Microbiology, Quality Investigations, Technical Problem-Solving Preferred Skills: 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 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 Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, d