Principal Scientist, Upstream Process Development (Biologics)

Location: Rahway, New Jersey, United States; US and Puerto Rico residents only. Regular onsite work; flexible work arrangements are not applicable. Domestic relocation is available, and visa sponsorship is available.

Base salary: $173,200–$272,600 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global develops biologics and drug substance manufacturing processes across discovery, clinical development, commercialization, and product launch.

What you will do

• Lead upstream process development for first-in-human and commercial biologics processes, developing high-yield, robust, and scalable cell culture processes.
• Provide technical direction for process development, characterization, commercialization, regulatory filings, PPQs, and BLAs.
• Advance upstream platform strategy and lead process improvement and pipeline-facing innovation initiatives.
• Collaborate with academia, industry partners, vendors, and manufacturing sites on new technologies, process transfer, and commercialization.
• Present and publish scientific work, monitor patents and literature, and pursue patenting strategies.
• Mentor and educate junior scientists while leading cross-functional teams and projects.

Requirements

• PhD with 6+ years of industry experience, or Master’s degree with 8+ years of industry experience, in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• Proven upstream process and technology development accomplishments with a strong scientific publication and presentation record.
• Experience with CHO fed-batch cell culture, cell culture media, CHO cell biology and metabolism, and a working understanding of downstream processing and analytics.
• Hands-on experience with microbioreactors, bench-scale and pilot-scale bioreactors, scale-up, technology transfer, and scale-down model qualification.
• Working knowledge of DOE statistics and computational fluid dynamics.
• Ability to plan, execute, analyze, and document all stages of cell culture process development.
• Knowledge of the biologics CMC development cycle and experience with late-stage commercial process development, process characterization, technology transfer, and regulatory filings.
• Ability to work in a matrixed environment with internal and external partners, take initiative, solve problems creatively, and lead cross-functional collaborations.
• Demonstrated ability to develop staff, guide career development, maximize talent utilization, and build collaborative teams.

Nice to have

• Experience with intensified inoculum and perfusion process development, high-throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
• Expertise in media development and media or solution chemistry.
• Experience with data science and predictive modeling for cell culture, including metabolic flux analysis, omics, machine learning, PAT integration, and computational fluid dynamics.
• Experience leading cross-functional program development teams.

Culture & Benefits

• Work in a cross-functional, matrixed research and development environment with academic, industry, vendor, and manufacturing partners.
• Regular employment with medical, dental, vision, insurance, retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Travel requirements are approximately 10%.
• The organization emphasizes inclusion, collaborative problem-solving, scientific excellence, and respectful challenge of ideas.

Hiring process

• Applications are accepted through the hirify.global careers application process; search firm submissions require a valid written agreement specific to this position.
• Accommodation support is available for US and Puerto Rico residents who need assistance during the hiring process.