Job Description

Description

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) at Spring House Innovation Park is seeking a Senior Scientist for the Early Development Vaccine team located at our Company's new state-of-the-art Spring House Innovation Park research facility in Lower Gwynedd, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable early phase clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.

The primary role of the successful candidate will be to optimize, validate, and implement molecular, serology or cell-based bioanalytical assays in support of early (Phase I and II) vaccine clinical programs. The individual will be responsible to contribute with limited supervision to all aspects of assay development, transfer to robotic platforms, technology transfer, assay qualification/validation, troubleshooting, and phase I/II sample testing support. The ideal candidate will have solid laboratory experience in the field of bioanalytical assay development, qualification/validation. Experience in developing and deploying assays in a GxP environment is desired. The candidate should be current on state-of-the art technologies and is expected to champion ongoing improvements in automated assay conduct. Providing expert technical representation on multidisciplinary teams will be expected.

Education Minimum Requirement

• B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with at least 7 years, M.S. with at least 4 years, or Ph.D. with hands-on experience in related field

Responsibilities

• Provide scientific input to the design and execution of molecular biology-based (e.g. NGS, PCR, qPCR, DNA extraction) or immunogenicity (e.g. ELISA) or cell-biological methods (e.g. VRNT) techniques.

• Develop expertise with laboratory automation (e.g., robotic platforms, liquid handlers) to drive end-to-end fully automated assay to support early (Phase I and II) stage clinical testing

• Responsible for the execution of method optimization, troubleshooting, and clinical sample analysis within a GxP laboratory

• Act as subject matter expert with internal or external teams and during audit on molecular methods and platforms (e.g., Quant Studios, KingFishers) and associated lab automation

• Accountability for generated data. May review data generated by others

• Understand and apply regulatory/compliance/scientific requirements relative to their role

• May publish and/or present technical papers to external audiences; participate in internal publications

• Use own scientific judgment to apply and adapt standard methods and techniques by applying prior work experience, consulting others appropriately

Required Experience & Skills

• Critical thinking and good trouble-shooting skills

• Experience optimizing, validating, and using molecular-based assays in support of non-clinical and/or clinical studies

• Adherence to basic safety procedures in a BSL2 laboratory

• Good verbal and written communication

• Ability to follow procedures and thoroughly document experiments

• Ability to communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams

Preferred Experience & Skills

• Experience with immunoassay platforms such as our Company, Luminex, ELISA, AphaLISA or Experience with molecular assays such as Next Generation Sequencing, PCR, qPCR, multiplexed PCR assays, and DNA extractions

• Familiarity with liquid handlers and other automation platforms for sample preparation and assay process

• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously

• Experience with Laboratory Information Management Systems (LIMS), electronic laboratory notebooks, and other scientific applications

• Experience performing computer system validations

• Experience operating in a GxP laboratory

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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

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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/2/2025

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