Job DescriptionCell Culture Sciences - Biologics Drug Substance Commercialization - Pilot OperationsWe are seeking a highly motivated Scientist to play a key role in
pilot plant operations, process scale-up, and drug substance commercialization for our late-stage biologics pipeline. In this role, you will independently lead technical activities, drive process understanding, and contribute to successful technology transfers and commercial readiness efforts.
Key ResponsibilitiesPilot Operations Leadership- Independently execute and support pilot-scale mammalian cell culture campaigns, including planning, setup, operation, monitoring, sampling, data analysis, and documentation.
- Serve as a technical lead during pilot operations and provide real-time troubleshooting support.
- Ensure safe, compliant, and efficient execution of pilot manufacturing activities.
Process Scale-Up & Commercialization- Lead and support scale-up efforts from laboratory through pilot and commercial manufacturing scales.
- Evaluate process performance across scales and identify opportunities to improve robustness and manufacturability.
- Author and review technical reports supporting process transfer and commercialization activities.
Technical Development & Validation- Design, execute, and analyze process characterization studies.
- Support process performance qualification (PPQ) and continued process verification initiatives.
- Contribute scientific and technical content for regulatory filings and inspection readiness activities.
Data Analysis & Process Understanding- Analyze process data to identify trends, deviations, and opportunities for improvement.
- Apply engineering and scientific principles to establish process understanding and support control strategy development.
- Present findings and recommendations to technical teams and leadership.
Cross-Functional Collaboration- Partner closely with Process Development, Manufacturing, Quality, Validation, Supply Chain, and Regulatory Affairs organizations.
- Support technology transfer activities between development, pilot, and commercial manufacturing sites.
- Collaborate across global teams to ensure alignment on commercialization objectives.
Continuous Improvement- Identify and implement operational improvements that enhance process reliability, efficiency, and compliance.
- Support implementation of new technologies, digital tools, and advanced manufacturing practices.
- Contribute to departmental initiatives focused on operational excellence and knowledge management.
Education & Experience- Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, Biotechnology, Biochemistry, or related discipline with 3-5 years of relevant industry experience
OR- Master's degree with 1-3 years of relevant industry experience
What You BringTechnical Expertise- Experience with mammalian cell culture development and/or manufacturing.
- Knowledge of bioreactor operations and scale-up principles.
- Experience supporting pilot-scale or GMP manufacturing operations preferred.
- Understanding of biologics process development, technology transfer, and commercialization activities.
Scientific & Analytical Skills- Ability to analyze and interpret complex process data.
- Experience with statistical analysis and data visualization tools preferred.
- Strong troubleshooting and problem-solving capabilities.
Leadership & Collaboration- Ability to independently manage technical workstreams and priorities.
- Effective communication and presentation skills.
- Strong collaboration skills across scientific, engineering, and manufacturing organizations.
Personal Attributes- Strong attention to detail and commitment to data integrity.
- Growth mindset with a passion for innovation and continuous improvement.
- Demonstrated ownership, accountability, and commitment to patient-focused outcomes.
Be a Catalyst for CommercializationJoin a team where science, engineering, and manufacturing come together to bring innovative biologic medicines to patients. As a Scientist in Cell Culture Pilot Operations & Drug Substance Commercialization, you will play a critical role in scaling processes, enabling manufacturing success, and shaping the future of biopharmaceutical production. #EBRG's #VetJobs
Required Skills: Biological Manufacturing, Biological Manufacturing, Biologics, Biopharmaceutical Manufacturing, Bioproducts, Biotechnology, Biotechnology Manufacturing, Cell Culture Techniques, Chemical Engineering, Clinical Manufacturing, Commercialization, Data Analysis, Data Integrity, Detail-Oriented, Downstream Process Development, Efficiency Improvements, Experimentation, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Maintenance Supervision, Pharmaceutical Process Development, Process Analytics, Process Definition, Process Improvements, Process Scale Up {+ 9 more}
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
Employee Status: Regular
Relocation:Domestic/International
VISA Sponsorship:Yes
Travel Requirements:10%
Flexible Work Arrangements:Not Applicable
Shift:1st - Day
Valid Driving License:No
Hazardous Material(s):N/A
Job Posting End Date:08/30/2026
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