Principal Scientist, Biologics Upstream Process Development

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.

Key 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.