Scientist, Engineering
About the role
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.
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
- 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.
Requirements
- 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.
- 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.
Qualifications
- Ability to analyze and interpret complex process data.
- Experience with statistical analysis and data visualization tools preferred.
- Strong troubleshooting and problem-solving capabilities.
- Leadership and collaboration skills across scientific, engineering, and manufacturing organizations.
- 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.
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
Benefits
The salary range for this role is $87,300.00 - $137,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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.