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Associate Principal Scientist, Engineering Job

Job Details

Associate Principal Scientist, Engineering-PRO014585

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.


Description:

Biologics Process Development and Commercialization (BPDC) is responsible for the commercialization of biological processes from Phase III through launch and transfer to commercial supply network. Activities include process development, scale-up and optimization, interfacing with a network of facilities for product manufacturing and subsequent validation and filing documentation, and transfer to supply network. BPDC is part of the Merck Manufacturing Division.

This individual will support late stage bulk process development, characterization, technology transfer, Clinical/commercial manufacturing, and validation studies associated with therapeutic proteins bulk processes. The individual will also apply advanced data analysis and data modeling techniques to improve the scientific and technical understanding of biological systems at small and large scales. Person will also support instrument automation working closely with IT.

Responsibilities:

•Provide technical support and leadership for drug substance development and characterization teams including the design, execution, and interpretation of lab-scale, pilot scale and manufacturing scale elements of technical program to ensure processes are suitable for PPQ, licensure, and commercial manufacturing
•Use first principles and design of experiments (DoE) to predict/understand/control the impact of cell culture process parameters on recombinant protein product including impact on metabolic pathways.
•Use first principles models and computational models to better understand scale-up and scale down.
•Collaborate with IT to support lab instrument automation
•Manage technical programs including establishing and delivering on project timelines and milestones
•Partnering with commercial manufacturing teams to provide upstream subject matter expertise to support ongoing manufacturing activities.
•Provide global support for commercial products (e.g. technical support, trouble shooting, deviation resolution, change control)
•Author, review and edit technical documents to support regulatory filings including technical reports, risk assessments, and CTD sections

Qualifications

Education Minimum Requirement:

•B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Mathematics, Statistics, or related field with 8 years of relevant experience; or Master's degree with at least 6 years of relevant experience; or Ph.D. with 3-5 years in the above mentioned field.

Required Experience and Skills:

•Subject Matter Expert with first principles modeling, advanced statistical analysis, Multivariate Analysis
•Working knowledge of R, Matlab, JMP, Minitab, Spotfire or related packages
•Experience with Visual Studio, Visio, SQL, .NET etc.
•Upstream process development or relevant experience including scaling (up and down) along with tech transfer of microbial fermentation and/or mammalian cell culture processes.
•Deep technical knowledge and in-depth experience with upstream process development.
•Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
•Outstanding communication and people skills.
•Therapeutic biologics commercialization experience.
•Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles.
•Experience with project strategic planning.

Preferred Experience and Skills:

•Mathematical modeling, data analysis/management and experience with instrument automation
•Upstream process development expertise with multiple programs and platforms
•Knowledgeable in Drug Substance, end to end process development.
•Strong cross functional background, enabling teams to reach peak performance.
•Ability to provide scientific mentorship and guidance to technical coworkers and colleagues within and outside of Merck.
•Experience supporting/writing regulatory filings (IND, BLA) and inspections with multiple agencies (FDA, EMA, JNDA,).

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 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: Process Engineering

Job Title:Assoc Prin. Scientist, Engineering

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: No

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

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