Scientist, Engineering Full-time

Biologics Cell Culture Scientist

Join Our Team as a Biologics Cell Culture Scientist!

Are you passionate about biologics manufacturing and interested in advancing innovative therapies from development to commercial production?

We 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.

Why You'll Love This Role

As a Scientist in Cell Culture Pilot Operations & Commercialization, you will serve as a technical contributor supporting the transition of cell culture processes from development to manufacturing. You will apply your understanding of cell culture operations, process engineering, and manufacturing science to enable reliable and efficient biologics production.

This role provides opportunities to:

• Lead pilot-scale cell culture campaigns
• Drive process scale-up and technology transfer activities
• Support process characterization and validation programs
• Contribute to regulatory submissions and commercial launch readiness
• Collaborate with multidisciplinary teams across development and manufacturing organizations

Your work will directly impact the successful commercialization of life-changing biologic medicines.

Key Responsibilities

Pilot 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 Bring

Technical 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 Commercialization

Join 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.

Required Skills: Biological Manufacturing, Biologics, Biotechnology Manufacturing, Cell Culture Techniques, Chemical Engineering, Clinical Manufacturing, Commercialization, Data Analysis, Detail-Oriented, Downstream Process Development, Efficiency Improvements, Experimentation, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Maintenance Supervision, Pharmaceutical Process Development, Process Analytics, Process Improvements, Process Scale Up

Preferred Skills:

Salary Range: $87,300.00 – $137,400.00

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.