Senior Scientist - Biologics and Vaccines Bioanalytics Job

Senior Scientist - Biologics and Vaccines Bioanalytics-BIO004676

Description

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.


Merck & Co. (BVB) supports assay development and sample testing of biologics drug, immunogenicity of protein therapeutics, biomarkers in biological matrices, immunogenicity, efficacy and safety of vaccines through multiple stages of development of biologics and vaccines. BVB Immunoassay & New Technology group is responsible for assay development and validation for both biologics and vaccines, and the development and implementation of new technologies for assays across all of BVB.

We are seeking a Senior Scientist to join our team in West Point.

Responsibilities:

- Develop and transfer cell-based functional assays to monitor immunogenicity to support Merck biologics and vaccine programs. Responsible for troubleshooting of issues occurred during method development or in-study phase.

- Responsible for method development and validation and/or pre-clinical/clinical sample analysis. Ensure GLP compliance. Support study protocol and assay validation report preparation. Address QA findings and observations.

- Interact with sample manager, bioanalyst, biostatistician, instrument scheduler, report writer, QC/QA, etc to track project progress and ensure on time delivery.

- Develop and implement new technologies for use in monitoring safety and efficacy of novel biologics therapeutics and vaccines.

- Evaluate and implement automation and process improvement in ligand binding assay and cell-based assay to enhance assay consistency and efficiency

Qualifications

Education:

• Bachelor’s Degree in immunology, microbiology, virology, molecular biology, biochemistry or related discipline with a minimum of 7 years of relevant experience or a MS Degree in immunology, microbiology, virology, molecular biology, biochemistry or related discipline with a minimum of 4 years of relevant experience or a Ph.d in immunology, microbiology, virology, molecular biology, biochemistry or related discipline

Required:

• Experience in development, optimization, validation and execution of cell-based assay for PK/immunogenicity of biologics/vaccines and in pharmaceutical/biotechnology or CRO industry.
• Experience in cell culture and cell-based assays
• Experience with MSD, Luminex, ELISA, and/or AphaLISA
• Familiar with liquid handlers and other automation platforms for sample preparation and assay process

Preferred:

• Experience in flow cytometry, In cell western, and/or high content imaging
• Experience in sample management
• Experience with phage display technologies
• Familiar with regulatory guidelines related to vaccine clinical testing and biologics bioanalytics

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 staffingaadar@merck.com.

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


Job: Biologics, Vaccines, Analytical Formulat

Job Title:Sr. Scientist, Bio & Vacc Formul

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Biohazardous material (BL2)

Company Trade Name:Merck