Senior Scientist – Biologics and Vaccines Analytics Job

Senior Scientist – Biologics and Vaccines Analytics-BIO004756

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.


Biologics and Vaccines Analytics (BVA), Global Vaccines and Biologics Commercialization (GVBC), Merck Manufacturing Division (MMD) is responsible for the commercialization of vaccine analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine availability. This team is highly motivated, fast-paced and focused on the rapid advancement of Merck’s vaccines pipeline, plus growth of existing products. This position will influence all stages of late stage development, validation, transfers and life-cycle management of methods supporting Merck’s vaccines pipeline and inline products. Specific job responsibilities will include analytical development, scale-up and optimization, and commercial life-cycle management of analytical strategy for vaccines.

Responsibilities:

- Lead the design, validation and execution of analytical method transfer to Merck global network of vaccines sites and external contract research organizations (CROs) for outsourced analytical testing. .

- Author regulatory submissions to support for global filings, including license application.

- Support analytical compliance and Quality for investigations and corrective actions.

- Collaborate with contract staffing on initiation, execution, and delivery of testing.

- Coordinate with cross-functional teams to support process development efforts, including overseeing analytical work and contributing to data interpretation (as required).

- Interface with internal and external partners, international governments, and/or contract manufacturing or testing organizations for vaccine analytics.

- Utilize continuous improvement for laboratory standardization, Lean laboratory, and Six Sigma methodology.

- Support Vaccine Assay Life Cycle activities across various vaccine franchises and analytical platforms.

- Support vaccine registrations, launches, and troubleshooting activities external to the US, including documentation preparation.

- Travel, as required (up to 25%).

Qualifications

Education:

- Required: Bachelor’s degree in biology, chemistry, biochemistry or related sciences.

Required:

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

- Minimum of two (2) years in cGMP laboratory

- Ability to work independently and within a cross-functional team.

- Capability to manage individual components of a project.

- Ability to learn new techniques and multitask.

- Good technical, communication (oral and written), interpersonal, and teamwork skills.

- Self-motivated with a positive attitude and proven performance record.

- Experience with mammalian cell culture, cell-based assays, and/or vaccine research, including at least one of the following techniques:

- Bioassay

- Viral Infectivity assays (plaque/TCID50/others)

- Plaque assay

- Cell Culture

- ELISA

- PCR/RT-PCR (traditional and real-time)

- Sequencing (traditional and MPS)

- Separation

- CE

- MS

Preferred:

- CMC document preparation.

- Experience with LIMS systems.

- Experience with continuous improvement or lean six sigma methodology.

- Project Management Experience

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:

EEOC Poster

EEOC GINA Supplement​



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, 25 % of the Time

Number of Openings: 1

Hazardous Materials: Vaccines, reagents, and chemicals used in normal lab-based positions.

Company Trade Name:Merck