Associate Principal Scientist, Translational Biomarkers Operations Job

Kenilworth, NJ, US
February 16 2017
Organization Type
Associate Principal Scientist, Translational Biomarkers Operations-BIO004787


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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual 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.

Primary activities:

- Primary liaison with Clinical Development’s Vendor Qualification (VQ) team for Translational Molecular Biomarkers (TMB) and Companion Diagnostics (CDx). Management of TMB/CDx vendor qualification activities including tracking of vendor Qualifications and audits, identify, prioritizing, and requesting new and re- qualification projects, representing TMB/CDx on the VQ team during active qualifications (including first and second tier assessments, SOP reviews, and if needed, lab visits), identification of issues and potential solutions for using a particular vendor, provide assessment of qualification, from a TMB/CDx perspective, with and/or without remediation elements, to VQ team.
- Own Vendor IT Security Assessment responsibilities for TMB/CDx
- With other TMB/CDx and Translational Biomarkers Operations members, develop and implement methods and material for standardizing assay implementation at vendors (vendor statement of work, kit requirements, eCRF information, etc.) improving consistency and efficiency.
- Determine/design biomarker logistic and planning needs for active clinical trials; provide assay-related material to clinical teams for assay implementation at vendors, support/facilitate issue identification and resolution of assay-related issues during trial execution at vendors. Foster collaboration with biomarker leads, TMB/CDx scientists, and other departments’ operations teams to assure alignment of requirements and logistics across protocols in support of clinical trial needs and vendor implementation and execution.
- Evaluate the need for new or updated SOPs for Translational Biomarkers’ (TBx) GCP/GLP activities; facilitate/participate writing, gaining approval, implementation, and training on new or changed SOPs for TBx; represent TBx and participate in the Merck Research Labs Standards Committee.
- Participate in TMB IT improvements to identify compliance-related requirements and develop and implement new SOPs as needed.

**Please Note: This position will be located in Rahway, NJ until May 2017 **



- BS with 5+ years in health related field
- MS with 2+ years
- PhD with 1+ year


- At least five (5) years experience in clinical trials operations
- Experience in GCP/GLP and Part 11 SOP writing and/or compliance activities


- Experience in GCP/GLP labs, project management and process improvement.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at

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

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

Job: Bio/Immuno Assay Development

Job Title:Assoc Prin. Scientist, Assay Development

Primary Location: NA-US-NJ-Kenilworth

Other Locations: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Company Trade Name:Merck

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