Principal Scientist, Upstream Development

Job Overview

Principal Scientist – Upstream Development Department (Rahway, NJ, USA). This role works closely with the Upstream Development Department to develop and refine the technical strategy for next‑generation processing of assets in early‑ and late‑stage clinical development.

• Lead biologic upstream process development for first‑in‑human and commercial processes, developing high‑yield, robust, and scalable cell culture processes.
• Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth path to successful PPQs and BLAs.
• Advance upstream platform process technical strategy and champion creative process improvement initiatives.
• Initiate new collaborations to assess new technologies and industry strategies relevant to the company.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies with broad impact.
• Keep up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.
• Supervise, coach, and educate junior scientists.

• Minimum Education:
  
  Ph.D. with 8+ years industry experience;
  Master with 10+ years industry experience;
  Bachelor’s with 14+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• Proven record of accomplishments in upstream process and technology development with a strong publication and presentation track record.
• Experience in CHO fed‑batch cell culture and a working understanding of downstream and analytics.
• Hands‑on experience with cell culture bioreactors including microbioreactors, bench‑scale and pilot‑scale bioreactors, and scale‑up/tech‑transfer activities.
• 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 internal and external partners including vendors.
• Knowledge of biologics CMC development cycle.
• Demonstrated initiative, creativity, and innovation in problem solving.
• Ability to develop staff, maximize utilization of talent, and actively guide career development; builds strong and collaborative teams.

• Experience with state‑of‑the‑art cell culture processes, including intensified inoculum and perfusion development.
• Experience with early‑ and 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.
• Expertise in media development, media/solution chemistry.
• Background in data science approaches related to cell culture and predictive modeling such as metabolic flux analysis, omics, machine learning, and integration of PAT efforts and computational fluid dynamics.
• Experience leading cross‑functional, program development teams.

The salary range for this role is $ – $. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, healthcare and other insurance benefits, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.