Associate Principal Scientist, Analytical R&D (Microbiologist) - Onsite

Job Description

The Analytical Research and Development Microbiology group has an opening for an Associate Principal 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 Associate Principal 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

• Lead the 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

• Drive experimental design, execution, and data interpretation of microbiology data.

• Oversee 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.

• Troublesh oot and lead any inves tigations associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders . Identify appropriate corrective and preventative actions.

• Partner with internal stakeholders and partners including Q uality , Pipeline, and Operations .

• Supervise microbiology testing, data entry, data review, and autho r / approve analytical reports and data summaries.

• Conduct project management and/or scientific oversight of studies performed at C ontract Laboratories

• 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 3 y ears of pharmaceutical industry experience for applicants with a PhD degree; 5 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, aseptic manufacturing, and finished product testing in a GMP environment

• Expertise in nonsterile and aseptic 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 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:

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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 presence.This 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

$139,600.00 - $219,700.00

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 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 .

You 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:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Analytical Reports, Applied Engineering, Assay Development, Biological Assay Development, Biological Sciences, Biomedical Sciences, Business, Cell-Based Assays, Chromatographic Techniques, Cross-Functional Teamwork, Environmental Monitoring, Environmental Monitoring Systems, Environment Management, External Audit, External Collaboration, Fast-Paced Environments, GMP Compliance, Good Manufacturing Practices (GMP), High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Management Process, Mass Spectrometry Analysis {+ 5 more}

Preferred Skills:

Job Posting End Date:

07/5/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.