Director, Regulated Bioanalytics Late-Stage Vaccine Clinical Development, Serology - Military Veterans

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Scientist for the Serology / Molecular> Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage 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. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

The primary role of the successful candidate will be to design and develop immunology-based bioanalytical assays in support of early vaccine programs. The individual will be responsible to contribute with limited supervision to all aspects of assay development, technology transfer, and/or troubleshooting. The ideal candidate will have solid laboratory experience in the field of immunology and/or cell biology, a broad skill set, encompassing working with primary immune cells to developing bioanalytical assays capable to meet clinical assay requirement. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes. 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 ligand binding assays (LBA), such as ELISA and/or cell-based assays, such as luciferase reporter assays
• Responsible for the execution of method development, troubleshooting, and/or pre-clinical/clinical sample analysis as needed
• Contribute to the assessment and implementation of new analytical technologies
• Serve as an internal subject matter expert on developed assays
• Accountability for generated data
• Understand and apply regulatory/compliance/scientific requirements relative to their role
• May publish and/or present technical papers to external audiences; participates in significant 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 in general cell biology methods, including maintenance of cell lines and/or primary cells
• Experience with immunoassays such as ELISA, AlphaLisa, multiplexed LBA on our company and/or Luminex platforms
• 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 cell-based assays in the context of immune response characterization, such as viral neutralization, PRNT/VRNT/FRNT, ELISpot, or multi-color flow cytometry
• 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

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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".

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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.

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

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Job Posting End Date:
12/21/2024
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