Job Details

Job Summary

We are seeking an experienced and highly motivated Principal Scientist to support growth into a late-stage clinical and commercial manufacturing environment. Reporting to the Senior Director of Biologics Development and Manufacturing, this role focuses on upstream process development and manufacturing-related activities. The ideal candidate will bring hands-on expertise in mammalian cell culture (CHO) and primary recovery, with a strong foundation in process development and characterization.

Responsibilities

• Establish upstream process development capabilities, including laboratory infrastructure, analytical equipment, and utilities.
• Recruit, mentor, and lead a process development team.
• Implement key unit operations such as solution preparation, shake flask culture, rocking cell bag, stirred-tank bioreactors, centrifugation, and depth filtration.
• Set up data acquisition and management systems (e.g., ELN templates).
• Develop and qualify scale-down models to support process development and characterization.
• Establish internal media and feed platforms to enable high-yield CHO processes.
• Apply Design of Experiments (DoE) to optimize and characterize upstream processes.
• Produce bench- and pilot-scale material to support downstream, analytical, and toxicology studies.
• Support external manufacturing activities, including technology transfer and troubleshooting process-related issues.
• Review and manage development, manufacturing, and validation documents.
• Author technical reports and present findings at departmental and cross-functional meetings.
• Ensure compliance with FDA, EMA, ICH, GMP, and company policies and procedures.

Qualifications

• Bachelors degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field required; advanced degree preferred.
• Ph.D. with 3+ years, M.S. with 6+ years, or B.S. with 8+ years of industry experience in upstream process development.
• Direct experience with mammalian cell culture bioreactors, including at least 2 years with ambr250 systems.
• Strong background in process characterization studies preferred.
• Knowledge of upstream process impact on product quality attributes desired.
• Experience with analytical methods for cell culture processes.
• Proven ability to analyze, interpret, and trend complex process data.
• Experience collaborating with CDMOs and supporting technology transfer desirable.
• Strong communication and interpersonal skills with the ability to drive problem-solving and teamwork.
• Ability to manage multiple priorities in a fast-paced environment.
• Detail-oriented with a focus on strategic objectives.
• Familiarity with programming languages or AI/ML tools to support process analysis is a plus.