Associate Principal Scientist, Upstream Process Development (Biologics)

Location: Rahway, New Jersey, United States; full-time onsite role. Domestic relocation is available. Travel requirements: 10%.

Salary: $142,400–$224,100 per year, plus annual bonus and long-term incentive if applicable.

Company

hirify.global develops medicines and biologics and operates research, development, manufacturing, and commercialization programs.

What you will do

• Develop first-in-human and commercial upstream processes that are high-yield, robust, and scalable for recombinant protein production.
• Lead process development, process characterization, and regulatory filing activities supporting PPQs and BLAs.
• Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, Manufacturing, vendors, academia, and industry partners.
• Develop integrated clinical and commercial manufacturing solutions, including quality-by-design targets and robust control strategies.
• Advance upstream platform processes through process improvement, technology innovation, and operational efficiency initiatives.
• Present and publish scientific work, monitor external literature, and pursue patenting strategies.

Requirements

• Ph.D. with 4+ years of experience or a Master's degree with 8+ years of experience in chemical engineering, bioengineering, biological engineering, or a related field.
• Hands-on experience with mammalian cell culture and fed-batch processes for recombinant protein production.
• Working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale recombinant protein production.
• Working knowledge of statistical methods, including design of experiments and multivariate data analysis, and tools such as SIMCA and JMP.
• Understanding of microbioreactors, bench-scale and pilot-scale bioreactors, and laboratory-to-large-scale bioreactor scale-up principles.
• Proven accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
• Ability to plan, execute, analyze, document, and communicate all stages of cell culture process development and complex critical data.
• Excellent verbal, written, organizational, multitasking, and interpersonal skills, including the ability to work effectively in cross-functional and matrixed environments.
• Demonstrated initiative, creativity, innovation, laboratory productivity, ability to deliver complex objectives under aggressive timelines, and proficiency in bioreactor simulation and modeling.

Nice to have

• Experience with cell culture media development, high-throughput microbioreactor systems, advanced in situ analytics, intensified inoculum or fed-batch processes, and perfusion process development.
• Data science experience related to cell culture and predictive modeling, including metabolic flux analysis, omics, machine learning, computational fluid dynamics, or PAT integration.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification, process characterization, and transfer to GMP manufacturing sites.
• Knowledge of the biologics CMC development cycle and scale-up or scale-down.

Culture & Benefits

• Regular employee position with medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Inclusive environment that values diverse perspectives, respectful challenge, collaboration, and collective problem solving.
• VISA sponsorship is available.