Sr. Scientist, Analytical R&D (Microbiologist) - Onsite
Sr. Scientist, Analytical R&D (Microbiologist) - Onsite
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
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 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
Support and execution of microbiology finished product testing utilities and environmental monitoring in GMP environment
Apply 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
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 principals
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.
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.
Education Minimum 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.
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 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
#eligibleforERP
#AR&D
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 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:
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 anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The salary range for this role is
$114700.00 - $180500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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 does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Adaptability Adaptability Analytical Method Development Applied Engineering Assay Development Bioanalytical Analysis Biochemical Assays Biological Sciences Biomedical Sciences Business Cell-Based Assays Chromatographic Techniques Environmental Monitoring Environmental Monitoring Systems Environment Management External Audit Fast-Paced Environments GMP Compliance GMP Environments Good Manufacturing Practices (GMP) Innovative Thinking Management Process Microbiological Test Nuclear Magnetic Resonance (NMR) Analysis Process Analytical Technology (PAT) 4 morePreferred Skills:
Job Posting End Date:
07/5/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
