Principal Scientist, Bioprocess Development

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. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our company's Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and experienced individual to join our Upstream Development Department as a Principal Scientist. In this role, the successful candidate will work closely with leaders in the Upstream Development Department to develop and refine group strategy related to next generation processing for assets in early and late stage clinical development. We are looking for a team player with strong leadership skills and ability and passion to mentor and develop junior staff. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong cross-functional collaboration, experience leading small groups of scientists, leading projects, and strong external presence through scientific excellence are expected.

The successful candidate will contribute to CMC development of our company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. She/He will also develop strategies for process and pipeline-facing innovation. Responsibilities include:
  • Leading upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
  • Providing strategic and technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for the company's pipeline
  • Advancing the upstream platform processes, and champion creative process improvement initiatives
  • Implement business processes and organizational infrastructure improvements to improve operational efficiency and reduce costs.
  • Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies
  • Collaborate with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies
  • Keep up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies


EDUCATION REQUIREMENTS:
  • Ph.D. with 8+ years of industry experience or Master with 12+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field


REQUIRED SKILLS:

  • Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
  • Experience in CHO fed-batch cell culture and a working understanding of downstream & analytics.
  • Understanding of bioreactor scale-up principles from laboratory to large scale
  • Understanding of upstream cell culture GMP manufacturing operations and troubleshooting
  • Working knowledge of cell culture media, CHO cell biology and metabolism, and DOE statistics
  • Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors
  • Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
  • Plan, execute, analyze and communicate critical data in a highly organized manner
  • Excellent verbal, written communication and interpersonal skills; ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors
  • Experience leading cross functional, program development teams
  • Knowledge of biologics CMC development cycle and scale-up/down, tech transfer to GMP manufacturing site
  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving
  • Productivity and efficiency working in the laboratory
  • Ability to deliver complex objective under aggressive timelines
  • Demonstrated ability to develop staff to maximize utilization of talent, and actively guides their career development; builds strong and collaborative teams.
  • Demonstrated ability to work effectively in cross-functional and matrix team settings


PREFERRED SKILLS:
  • Experience with late stage commercial process development, technology transfer, scale-down model qualification and process characterization
  • Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control
  • Experience with cell culture media development and preparation
  • Experience with state-of-the-art cell culture processes including intensified inoculum, fed-batch and perfusion process development
  • Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)


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.

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.

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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/International

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Not Specified

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R135289