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Principal Scientist

Requisition ID: PHA001485

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.¬ 



We are seeking a highly motivated principal scientist to join the Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) in the area of Regulated Immunogenicity/Molecular Biology Bioanalytics. The qualified candidate will be responsible for establishing our scientific strategy to influence general and program-specific immunogenicity (anti-drug antibody, ADA) assay development with a line of sight to successful biologics product approvals.¬ ¬ 



Reponsibilities include:


‚€ĘScientific leadership and oversight of the development and validation of new immunogenicity assays for GLP and clinical applications.¬ 


‚€ĘAuthor regulatory filings and respond to regulatory authority questions pertaining to bioanalytical immunogenicity strategy and execution.¬  The candidate will perform risk assessments, author reports, and interpret study data.


‚€ĘBenchmarking current approaches/techniques to the industry standards.


‚€ĘDesign, pressure-test, and implement novel approaches, such as new technology, automation, and workflows.


‚€ĘThe candidate is expected to remain current in the field and maintain an external presence in the field of biologics immunogenicity.¬ 




Knowledge of preclinical and clinical testing in a regulated environment, and experience as a technical lead or scientific mentor is required.¬  The candidate will be expected 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.




Qualifications

Education Minimum Requirement:¬ 



  • PhD in Biological Sciences such as Microbiology, Immunology, and Biochemistry, or related area with 8+ years, a MS degree with 10+ years, or BS degree with 14+ years of relevant experience.



Required Experience and Skills:¬ 



  • Experience in bioanalytical immunogenicity assays across multiple platforms.¬  ¬ Deep knowledge and expertise in development, validation, and troubleshooting of ligand binding assays on electrochemiluminescence, or related, platform.¬  ¬ 

  • Track record in designing ligand binding assays for regulated application, and direct experience with regulatory submissions of bioanalytical assays and strategies.¬ 

  • A team player with excellent oral and written communication skills; ability to work independently and as a scientific mentor for development and validation of assays.

  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.¬  Excels at working cross-functionally, and gaining alignment of new ideas or strategies.¬ ¬ 


Preferred Experience and Skills:



  • Working knowledge of regulatory and industry guidelines in the area of biologics immunogenicity anti-drug antibody testing.

  • Experience in oncology and/or immunology.

  • Experience implementing new technology or automation platforms.

  • Proficiency¬  utilizing statistical software for design of experiments.

  • Excellent scientific publishing record.





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.¬ 


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


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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.


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


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¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC Poster


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC GINA Supplement¬ 


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬  OFCCP EEO Supplement


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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:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: No
Company Trade Name: Merck

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