Job Description

Job Description

The Biologics Process Research & Development organization within our Company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline, including cell line, upstream and downstream process development. We work closely with colleagues in Discovery, Preclinical, and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and we efficiently produce drug substance to supply clinical trials. We are also responsible for late-stage/commercial process development, and the development of new manufacturing technologies. We work with our partners in our Manufacturing Division to commercialize and launch new products. This position is based in Kenilworth, New Jersey.

In the role of Principal Scientist, Biologics Upstream Process Development, you will direct an upstream group responsible for the development and implementation of manufacturing processes for early and late stage clinical, and commercial. This role has accountability for our cell culture medium business, particularly, covering medium service supporting pilot plant and lab development usage; establishing deep understanding of solubility, filtration, and stability for our platform media; advancing spent medium analysis capability and throughput; and platform media development and implementation in manufacturing. You will demonstrate sound scientific understanding and working knowledge of cell culture media, bioreactor engineering principles, and product quality attribute science, and will have broad skillsets in technology transfer, scale-up, manufacturing operations, and regulatory CMC (Chemistry, Manufacturing and Controls) strategies.

Key responsibilities include:
Leads pipeline program development work for first-in-human and commercial processes, efficiently developing high yield, robust and scalable cell culture processes
Provides strategic and technical directions for process characterization, commercialization activities, and regulatory, ensuring a smooth and clear path to PPQ (Process Performance Qualification) and BLA (Biologics License Application)
Advances upstream first-in-human platform, and supports creative process improvement initiatives
Guides the medium group in providing reliable and efficient service to support media requests and spent medium analysis, while continually improving formulation and chemistry understanding to develop better media
Leads technology development and innovation to develop and implement new process technologies and capabilities
Implements business process and organizational infrastructure improvements to improve operational efficiency and reduce cost
Partners with colleagues in Discovery, Downstream Process Development, Analytical Sciences and Manufacturing to develop integrated manufacturing solutions that achieve quality by design targets with robust control strategies
Collaborates with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies
Keeps up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies
Develops staffs to maximize utilization of talent, and actively guides their career development; builds strong and collaborative teams.

Education Minimum Requirement:
PhD in biochemical engineering, chemical engineering, bioengineering or related biological sciences with 8+ years of industry experience, MS with 10+ years of industry experience, or BS with 14+ years of industry experience

Required Skills:
Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record
Background in fed-batch cell culture and working knowledge of downstream and analytics.
Working knowledge of cell culture medium development, CHO (Chinese Hamster Ovary) cell biology and metabolism, and Design of Experiment statistics
Strong organizational skills with the ability to manage multiple programs in a matrix environment, strong collaboration skills and the ability to work strategically as well as in a detail-oriented framework.
Demonstrated ability to manage and lead people and excellent verbal and written communication skills.

Preferred Experience:
Late-stage commercial process development, scale-down model qualification, process characterization
The use of a high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control
Large scale medium preparation process and equipment
Leading cross-functional, highly complex project teams
Proven ability to translate organizational objectives into actionable strategies
Recognized as an expert in the field with demonstrated skills managing external collaborations
Solid understanding of bioreactor scale-up principles in large scale production and GMP manufacturing troubleshooting

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Work Week

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R100825