Senior Scientist - Biologics and Vaccines Bioanalytics Job

Senior Scientist - Biologics and Vaccines Bioanalytics-BIO004729

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. Biologics and Vaccines Bioanalytics (BVB) supports PK, immunogenicity and biomarker assay development, validation and testing for development stages (preclinical and clinical) and life-cycle management of Biologics and Vaccines programs.

We are seeking a highly motivated candidate with a strong technical background in mass spectrometry and bioanalysis from a regulated lab to develop LC-MS/MS methods for implement LC-MS/MS technologies and hybrid LC-MS/immunocapture methods for absolute quantification of biologics molecules (biotherapeutic proteins including but not limited to monoclonal antibodies, and anti-drug antibodies) in biological matrices, to support PK and immunogenicity assessments for pre-clinical and clinical studies.

As a mass spectrometry technical lead in the Immunoassay and New Technology group of BVB, the incumbent will be responsible to:

- Develop LC-MS and hybrid LBA/LC-MS methods for the bioanalysis of biopharmaceuticals, biomarkers and immunogenicity. Utilize creative and analytical capability to troubleshoot challenging assays.

- Carry out projects with minimal coaching and use sound judgment in prioritization. Provides credible scientific/technical output with little supervision.

- Design and execute assay qualification and validation, prepare validation protocol, method validation report, and standard operating procedures. Conduct sample analysis and data review in a GLP compliant laboratory.

- Evaluate and implement new technologies to expand capabilities and enhance efficiencies. Maintain awareness of current trends, issues and developments, bring innovation to the bioanalytical team

Qualifications

Education:

- BA/BS degree in biology-related discipline with a minimum of 7 years of laboratory experience or a MS degree in biology-related discipline with a minimum of 4 years related laboratory experience or a PhD in a biology related discipline.

Required:

- Capable of working independently under moderate supervision and possess good communication skills (written and verbal).

- Extensive experience with LCMS-based assay development and validation/qualification

- Excellent working knowledge of HPLC, triple quad MS, extraction techniques and quantitative assays by LC-MS/MS.

- Experience in large molecule bioanalysis including various sample preparation techniques for LC-MS: direct digestion, pellet digestion, solid phase extract, and immunoprecipiation.

- Excellent working experience with LIMS (e.g., Watson) for quantitation, data handling and archival.

- Extensive experience in bioanalysis in GLP compliance environment

Preferred:

- Experience in providing scientific oversight for bioanalytical projects placed at CROs

- Experience with ligand binding assays (immunocapture), or high resolution mass spectrometry applications.

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-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 2

Shift (if applicable): N/A

Company Trade Name:Merck