Principal Scientist, Upstream Process Development

MSD•Rahway, NJ

About The Position

The Biologics Process Research & Development organization within our Research & Development Division 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 late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. We are seeking a highly motivated and experienced individual to join our team as a Principal Scientist. In this role, the successful candidate will lead cross-functional teams to develop CMC packages for our pipeline assets. The successful candidate will also collaborate with fellow Bioprocess Development colleagues to develop and refine technical strategy related to next generation processing for assets in early- and late-stage clinical development. 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 successfully mentoring junior scientist, leading projects, and strong external presence through scientific excellence are expected.

Requirements

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 and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.
Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.
Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors.
Knowledge of biologics CMC development cycle.
Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.
Adaptability
Cell Culture Process Development
Cell Line Development
Combination Products
Data Analysis
Finite Element Analysis (FEA)
Innovative Thinking
Leadership Mentoring
Pharmaceutical Process Development
Professional Collaboration
Professional Networking
Quality by Design
Regulatory Filings
Strategic Thinking
Technology Transfer

Nice To Haves

Experience with state-of-the-art cell culture processes including intensified inoculum and perfusion process development.
Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
Expertise in media development, media/solution chemistry.
Background in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).
Experience leading cross functional, program development teams.
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Responsibilities

Leading biologic upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
Providing technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for our company pipeline.
Advancing upstream platform process technical strategy and championing creative process improvement initiatives
Initiating new collaborations to assess new technologies and industry strategies with relevance to our Company.
Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies with broad impact to projects or platform.
Keeping current with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.
Mentoring and educating junior scientists