Associate Principal Scientist, Microbiology AR&D

Job Description

Small Molecule Analytical Research and Development (SMARD) is seeking a highly motivated Associate Principal -Microbiologist to join the growing Microbiology Center of Excellence (COE).  Based our company's Headquarters in Rahway NJ, this position is responsible for supporting the full company Portfolio which includes small molecule, biologics and vaccines.  As a main contributor to the implementation of new technologies and alternate microbiological methods, and – with the adequate background - The individual interacts with internal and external partners to foster collaborations and actively contributes to the establishment of our Research & Development division Micro CoE.

Responsibilities include supporting the rapidly growing pipeline via collaboration with stakeholders for various projects, validations, and implementation of alternate micro methods.

Providing technical guidance as well as critical thinking to help resolve scientific and technical issues.

This position is based at Rahway, New Jersey, site.
 

Additional Responsibilities:

• Highly capable subject matter expert in non-routine and routine testing. High proficiency in all tests, techniques and background principles of every procedure and method within the Micro area of expertise.

• In depth knowledge of chosen area within Microbiology. Generating new technology performance qualification protocols, their execution and generation of protocol final reports and assessment of their suitability tall within a GMP compliant standard.

• Inter site collaboration for new projects for the continuous improvement of the Microbiology area.

• To participate in Audits with regulatory bodies.

• To deliver training on new methods and technologies introduced into the lab.

• To lead constant lab flow efficiency improvements (MPS), contribute ideas on how to improve existing systems.

• To be proficient in highly specialized testing not common in the industry such as Mycoplasma testing.

• Contributes to the external scientific community (publications, presentation, consortia

• Drives scientific, technology, and engineering innovation with internal / externals partners

• Directly contributes to experimental design, execution and data interpretation for projects via individual and collaborative contributions

• Understands the available technologies and expertly applies them as a source of innovative solutions to pipeline problems.

• Anticipates and solves significant scientific and technical challenges.

Education Minimum Requirement: 

• Minimum 4 years of pharmaceutical industry experience for applicants with a PhD degree; 8 years of experience with a MS degree, or 12 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

• Demonstrates knowledge of rapid methodologies and relevant regulations, including bringing in and qualifying new technologies to improve turnaround time for testing processes.

• Has experience with rapid technologies for sterility testing, rapid incubation of testing media, endotoxin detection, and advanced microorganism identification methods.

• 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

• Experience with MODA preferred

Leadership

• Demonstrated ability to mentor, guide, and develop laboratory staff, fostering a collaborative and high-performance work environment.

• Proven experience in managing cross-functional teams and coordinating microbiology projects to meet deadlines and quality standards.

• Strong decision-making skills and the capacity to lead by example, ensuring compliance with regulatory requirements and company policies.

#AR&D

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Assay Development, Biological Assay Development, Biological Sciences, Biomedical Sciences, Cell-Based Assays, Chromatographic Techniques, Collaborative Development, Cross-Functional Teamwork, Endotoxin Testing, Environmental Monitoring, External Collaboration, GMP Compliance, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Manufacturing Compliance, Mass Spectrometry Analysis, Microbiological Analysis, Microbiological Test, Optimism, Process Analytical Technology (PAT), Protein Analysis, Regulatory Compliance {+ 2 more}

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:

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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 another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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

$142,400.00 - $224,100.00

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, 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

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/15/2026

*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.