Associate Principal Scientist, Upstream Development
$142,400–$224,100 year
On-site · Rahway, New Jersey, United States
Job Summary
Lead upstream process development for first-in-human and commercial biologics programs, driving high-yield, robust, scalable cell culture processes and contributing to regulatory filings (PPQs and BLAs). Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process solutions, advance platform technologies, and drive cost-efficient improvements. Mentor junior staff, publish and present externally, and pursue patenting strategies while collaborating with academia, industry partners, and vendors to adopt new process technologies. Maintain up-to-date understanding of external literature and patent landscape; apply data science approaches to cell culture and predictive modeling; contribute to tech transfer to GMP manufacturing and scale-up activities. Exhibit strong scientific leadership, cross-functional collaboration, and effective communication to deliver results on aggressive timelines.
Required Qualifications
- Minimum Education: Ph.D. with 4+ years' experience OR Master's with 8+ years' experience OR Bachelor's with 12 years' experience in chemical engineering, Bioengineering, Biological Engineering, or related field
- Technical background in mammalian cell culture and fed-batch processes to produce recombinant proteins
- Knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large-scale recombinant protein production
- Working knowledge of statistical methods (design of experiments, multivariate data analysis) and tools (e.g., SIMCA, JMP)
- Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scale-up principles
- Proven track record in upstream process and technology development with strong publication/presentation record
- Ability to direct planning, execution, analysis, and documentation of cell culture process development
- Ability to communicate complex data clearly and work in cross-functional, matrixed teams
- Experience collaborating with academia, industry partners, and vendors to drive development and adoption of new process technologies
- Experience with technology transfer to GMP manufacturing sites
- Knowledge of biologics CMC development cycle and scale-up/down and tech transfer to GMP sites
- Strong written and verbal communication, interpersonal skills
- Ability to deliver results under aggressive timelines
- Experience with data science approaches related to cell culture and predictive modeling (e.g., MFA, omics, machine learning)
- Experience with late-stage commercial process development and scale-down model qualification
- PAT and in situ analytics experience beneficial
- Experience with process development for first-in-human and commercial programs
- Regulatory filing activities to ensure smooth path to PPQs and BLAs
- Mentoring junior staff and cross-functional collaboration
Additional Requirements
- US-based applicants only or as specified by the posting
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