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 support to the production departments that manufacture sterile vaccines.

• Provide education and coaching on aseptic techniques, Good Manufacturing Practice requirements, and regulations including European Annex 1.

• Provide microbiology support to operational investigations and problem-solving, including leading and authoring investigations and analyses to determine root cause and impact, recommending corrective actions, and seeing them through to successful, sustainable implementation as well as reviewing investigations and analyses for thoroughness and accuracy.

• 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

• Participation in internal and external audits

• Troubleshooting of suspected Microbiological Contamination incidents

Education

• B.S. or B.A. degree in Biology, Microbiology or related science with ten (10) years of relevant experience that includes quality assurance/control, microbiology research or manufacturing operations

• Master's Degree (MA/MS) in Biology, Microbiology or related science with eight (8) years of relevant experience that includes quality assurance/control, microbiology research or manufacturing operations

• PhD with a concentration in Biology, Microbiology or related science with five (5) years of relevant experience that includes quality assurance/control, microbiology research or manufacturing operations

Required Experience and Skills

• Extensive knowledge of clinical and environmental microbiological principles

• Strong problem-solving skills and a hands-on approach to problem solving

• Sterile, aseptic, or 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.

Preferred experience and skills

• National board certification or licensure in Microbiology or related discipline (E.x. ABMM (ASM), MLS/SM (ASCP), etc.)

• Working in a cGMP environment

• Participation in regulatory agency inspections

• Demonstrated leadership skills and the ability to find innovative solutions to problems and requests.

• Experience with laboratory data management systems (i.e., LIMS)

Current Employees apply HERE

Current Contingent Workers apply HERE

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's 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".

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

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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.

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Relocation:

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Requisition ID:R340146