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Senior Scientist – Cell-based Clinical Assay
at Merck USA
West Point, PA

Senior Scientist – Cell-based Clinical Assay
at Merck USA
West Point, PA

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Description

Requisition ID: PHA001547

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


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.

We are seeking a highly motivated Senior Scientist to join the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) in the area of Regulated Immunogenicity/Molecular Biology Bioanalytics. The primary role of the successful candidate will be to design and develop cell-based preclinical and clinical assays for our Vaccines pipeline.  The individual will be responsible to lead aspects of assay development, qualification/validation, transfer, and/or troubleshooting The successful candidate will provide input in the design of experiments to optimize existing cell-based assay techniques, evaluate new techniques, validate and troubleshoot vaccine and biologic assays, and test clinical samples as needed.  Providing expert technical representation on multidisciplinary teams will be expected. The successful candidate will also maintain familiarity with relevant literature to apply scientific best practices to internal processes and identify opportunities to improve quality of work. 

Responsibilities:  
•Design functional immunoassays such as cell-mediated immune cell assays and virus neutralizing antibody assays for both preclinical GLP and clinical studies. 
•Responsible for assay format selection and implementation based on scientific rationale and program objectives for vaccines cell-based assays. Responsible for method development, validation, and sample analysis for pre-clinical/clinical studies as needed. 
•Assess and implement new technologies for cell-based immunoassays.
•Serve as an internal subject matter expert on developed assays, providing technical support, as needed to internal and external laboratories working to implement assays.
•Ensure assays are developed and executed in compliance with applicable Guidance and Regulations.  Contribute to assay protocol and validation report preparation. Address QA findings and observations. 
•Author regulatory filings and respond to regulatory authority questions pertaining to bioanalytical strategy and execution.  
•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


Qualifications

Education Minimum Requirement: 
Degree in Immunology, Cell Biology, Microbiology, Biochemistry or a related Biological Sciences discipline.
BA/BS with 7+ years, MS with 4+ years, or a Ph.D with related Bioanalytical experience.

Required Experience and Skills: 
•In-depth knowledge of the principles and concepts of vaccine infectivity and neutralizing assay development, optimization, and validation.
•Demonstrated expertise in PBMC isolation, cell culture, and cell-mediated immunity assays (such as ELISpot and multi-color flow cytometry (including intracellular cytokine staining and immune cell phenotyping).
•Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment.
•Experience in an industrial setting and experience in Good Laboratory Practice (GLP) preferred.
•Excellent communication and writing skills.
•Adherance to basic safety procedures in a BSL2 laboratory.

Preferred Experience and Skills:
•Experience with microplate imaging systems and multiplex plate readers preferred. 
•Familiarity with liquid handlers and other automation platforms for sample preparation and assay process is preferred.
•Experience in new assay technology evaluation
•Solid publication record and a desire to continue publication


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request tostaffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Pharmacokinetics/Drug Metab
Other Locations: Kenilworth, NJ, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: yes; Chemical, Vaccine
Company Trade Name: Merck

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