Job Description

The Site Analytical Science team within Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team provides support of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support. The position will work closely with partners with Large Molecule Analytical Science (GQLMAS), Sterile Quality Assurance Center of Excellence, Technical Operations, Operations and our manufacturing division Quality to provide site microbiology support. The successful candidate will have the opportunity to apply his or her enthusiasm and microbiological skills in the operation and improvement of a manufacturing facility. This role requires the ability to manage multiple complex projects, activities, and/or investigations. The role also requires active participation in cross-functional site teams.

Primary activities include, but are not limited to:

  • Provides microbiology subject matter expertise support to the production departments that manufacture sterile vaccines.
  • Troubleshooting of suspected Microbiological Contamination incidents
  • Provide microbiology support to operational investigations and problem-solving, including leading investigations and analyses to determine root cause and impact, recommending corrective actions, and seeing them through to successful, sustainable implementation
  • Providing microbiological leadership and support for a vaccine manufacturing facility, including data analysis, troubleshooting, problem solving, coaching/teaching, preparing, reviewing and approving relevant documentation for technical and regulatory compliance
  • Hands-on leadership and participation in laboratory activities / production floor
  • Participation in internal and external audits
  • Provide education and coaching on aseptic techniques, Good Manufacturing Practice requirements, and regulations including European Annex 1.
  • Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
  • Authors and approves technical documentation to support laboratory and manufacturing investigations and process enhancements.

Education

  • Bachelor of Science (BS) degree with eight (8) years working experience in microbiology or a related discipline in a pharmaceutical, biotech, or academic setting; OR
  • Master of Science (MS) degree with six (6) years working experience in microbiology or a related discipline in a pharmaceutical, biotech, or academic setting; OR
  • PhD with concentration in Biology, Microbiology or related science with three (3) years working experience in microbiology or a related discipline in a pharmaceutical, biotech, or academic setting.

Required Experience and Skills

  • Extensive knowledge of clinical and environmental microbiological principles
  • Expertise in a range of molecular and cellular characterization techniques
  • Strong problem-solving skills and a hands-on approach to problem solving
  • Microbiological experience in a manufacturing environment
  • Working knowledge of regulatory expectations of aseptic processing
  • Project management skills and experience
  • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
  • Experimental Design
  • Ability to collect and analyze data
  • Demonstrated initiative and innovative process-oriented thinking within a team environment.

Preferred experience and skills

  • National board certification or licensure in Microbiology or related discipline (E.x. ABMM (ASM), MLS/SM (ASCP), etc.)
  • Participation in regulatory agency inspections
  • Experience in vaccine development or manufacturing
  • Track record of publications
  • Sterile, aseptic, or microbiological experience in a manufacturing environment

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

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

$126,500.00 - $199,100.00

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:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Aseptic Processing, Aseptic Processing, Audit Management, cGMP Training, Corrective Action Management, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, Good Manufacturing Practices (GMP), Management Process, Microbiological Cultures, Microbiology, Molecular Microbiology, Product Lifecycle, Product Management, Project Management, Quality Control Documentation, Quality Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management, Regulatory Compliance, Social Collaboration, Supplier Quality Management {+ 1 more}

Preferred Skills:

Job Posting End Date:

07/7/2025

  • 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.
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Confirmed 13 hours ago. Posted 5 days ago.

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