Sr. Scientist - Global Vaccine and Biologics Commercialization Job

Sr. Scientist - Global Vaccine and Biologics Commercialization-BIO004687

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.


Global Vaccine and Biologics Commercialization (GVBC), part of Merck Manufacturing Division (MMD), is responsible for the commercialization of vaccines and biologics from Phase III through launch and transfer to supply. Within GVBC, the BioAnalytics department is involved in analytical support of vaccines' and biologics’ process development, optimization, late-stage and life-cycle management. Departmental activities include interfacing with a network of facilities for product manufacturing and testing, analytical optimization, assay validation, analytical technical transfer, BLA filing documentation, and transfer to supply network for new products and support of inline products.

Responsibilities of the Senior Scientist will include and are not limited to the following:

- Will coordinate with cross functional teams to support and oversee analytical work in support of process development efforts, and will contribute to data interpretation as required.

- Will interface with internal and external partners, international governments and/or contract manufacturing and testing organizations in the area of vaccine analytics

- At any given time, could be responsible for contributing to and coordinating analytical activities across multiple projects.

- Will develop and optimize cell-based, microbiological, immunochemistry-based analytical methods.

- Will prepare and execute analytical method transfers and assay method validations - write and coordinate review of protocols and reports.

- Will assist in the development and execution of critical reagent qualification protocols and stability studies as needed.

- Will assist with the technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.

- Will contribute as author to regulatory submissions.

- Will oversee dotted-line reports across a portfolio of projects as needed.

Qualifications

Education:

- Bachelor of Science in a biological systems based science field such as Biomolecular sciences

Required:

- Experience with mammalian cell culture and cell-based assays

- Experience in analytical development and quality control (QC), with a working knowledge of current Good Manufacturing Practices (cGMP).

Preferred:

- Experience with live viruses and/or viral vaccines

- Experience with cross-functional teams

- Experience with contract organizations

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.

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.

Visa sponsorship is not available for this position.

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: 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

Hazardous Materials: The position will require hands-on laboratory work and use of low amounts of common laboratory reagents, chemicals and vaccines.

Company Trade Name:Merck