Sr. Scientist, Pharmacokinetics
Merck
**Job Description**
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics Regulated Bioanalytics Department is seeking a Senior Scientist for the 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 immunoassays), and cell-based assays (e.g., neutralization 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 optimize, validate, and implement molecular-based bioanalytical assays in support of late stage vaccine programs. This colleague will be accountable to contribute with limited supervision to all aspects of assay development on robotic platforms, technology transfer, validation, troubleshooting, and phase III sample testing support. The ideal candidate will have solid laboratory experience in the field of molecular biology, deploying primarily PCR based bioanalytical assays in a GxP setting to drive clinical studies forward. 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 methods including PCR, qPCR, DNA extraction, and related techniques
+ Develop expertise with laboratory automation (e.g., robotic platforms, liquid handlers) to drive end-to-end fully automated assay to support late 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 with molecular assays such as PCR, qPCR, multiplexed PCR assays, and DNA extractions
+ 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
+ Experience operating in a GxP 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 the development and implementation of next-generation sequencing (NGS) and/or other DNA sequencing assays
+ 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
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**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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
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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.
**Employee Status:**
Regular
**Relocation:**
No relocation
**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:**
04/1/2025
***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.**
**Requisition ID:** R340773
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