Skip to main content

This job has expired

Associate Principal Scientist – Biologics and Vaccines Job

Job Details

Associate Principal Scientist – Biologics and Vaccines-BIO004759

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 (including, but not limited to the following):

- Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics.

- Coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and technology transfers between Merck, external partners and CMO/CROs.

- Contribute to and coordinate analytical activities across multiple projects.

- Lead cross functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes.

- Develop and optimize cell-based, microbiological, immunochemistry-based analytical methods (in lab).

- Prepare and execute analytical method transfers and assay method validations, including writing and coordinating the review of protocols and reports.

- Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting.

- Develop and execute critical reagent protocols for qualification and stability studies.

- Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.

- Oversee dotted-line reports across a portfolio of projects.

- Manage contract employees as needed

- Coordinate analytical issue resolution via subject matter experts within the global vaccines network (as needed).

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

- Contribute as author and reviewer to regulatory submissions including marketing applications.

- Travel as required up to 25%

Qualifications

Education:

- Required: B.S. in molecular/cellular biology, bioengineering or equivalent bio-related science with minimum eight (8) years of relevant industry experience; or M.S. in molecular/cellular biology, bioengineering or equivalent bio-related science with minimum five (5) years of relevant industry experience; or Ph.D. in molecular/cellular biology, bioengineering or equivalent bio-related science with minimum three (3) years of relevant industry experience.

Required:

- Experience with late stage assay development, validation, technical transfer, and trouble-shooting.

- Experience with drug substance and drug product release, stability and extended characterization testing for vaccines.

- Experience developing analytical comparability protocols and reports.

- Strong organizational and project management skills.

- Strong oral and written communication skills.

- Ability to work independently with minimal supervision.

- Ability to effectively identify and communicate risks.

- Experience with deviation management and change control processes.

- Experience in effectively managing analytical development and testing activity at external vendors such as CMOs.

- People management skills.

- At least 3 years working experience in a cGMP laboratory environment in the area of vaccines with knowledge 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.

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:Assoc Prin. 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

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert