Manufacturing Sciences Scientist – Upstream Cell Culture

Location: Lexington, MA - Hybrid

Rate: $60-68/hour, 6-month contract to start with the possibility of extension

About the role

We are seeking an experienced Manufacturing Sciences Scientist to provide technical leadership and scientific expertise in support of commercial mammalian cell culture manufacturing operations. As a key member of the Manufacturing Sciences team, you will support upstream manufacturing by ensuring robust process performance, troubleshooting manufacturing challenges, driving continuous improvement initiatives, and supporting technology transfer activities. This role partners closely with Manufacturing, Process Development, Quality, Automation Engineering, and Technical Operations to optimize commercial cell culture processes, resolve process deviations, and implement data-driven improvements that enhance product quality, process reliability, and operational efficiency.

Responsibilities

• Provide real-time technical support for commercial cell culture manufacturing operations.
• Attend daily manufacturing meetings and serve as the primary technical resource for upstream process issues.
• Monitor and troubleshoot cell culture processes, including evaluation of bioreactor performance and process data.
• Support manufacturing personnel through technical guidance and process training.
• Participate in inspection readiness activities and provide support during regulatory inspections.
• Participate in rotating weekend on-call support as needed.
• Monitor process performance to ensure consistent manufacturing operations.
• Analyze manufacturing trends and process data to identify opportunities for optimization.
• Support the continued development and implementation of advanced process monitoring strategies, including real-time multivariate monitoring systems for bioreactor operations.
• Collaborate with Manufacturing Sciences SMEs, Automation Engineering, Process Development, and Manufacturing to enhance process monitoring capabilities.
• Identify, lead, and implement continuous improvement initiatives that improve process robustness, manufacturing efficiency, and product quality.
• Apply scientific and statistical analysis to evaluate process performance and recommend improvements.
• Utilize operational excellence and quality improvement tools to drive sustainable process enhancements.
• Support the transfer of Phase I, Phase II/III, and commercial cell culture processes into GMP manufacturing facilities.
• Partner with Process Development and Tech Transfer teams to ensure successful implementation of new manufacturing processes.
• Assess process requirements against existing manufacturing capabilities and recommend technical solutions when needed.
• Lead technical investigations related to manufacturing deviations and process events.
• Support deviation investigations, root cause analysis, CAPA development, and change control activities.
• Ensure timely, thorough, and well-documented responses that meet cGMP and quality system requirements.

Requirements

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or a related scientific discipline with 5-8 years of relevant experience, Master's degree with 5-8 years of relevant experience, or Ph.D. with a minimum of 2 years of relevant process development or manufacturing experience.
• Experience supporting mammalian cell culture manufacturing or process development for recombinant protein production.
• Hands-on experience with large-scale upstream manufacturing processes, preferably supporting commercial or licensed biologic products.
• Experience with technology transfer and manufacturing process scale-up.
• Strong understanding of bioreactor operations, upstream processing, and protein capture/recovery.
• Experience working in a cGMP manufacturing environment.
• Familiarity with sterile/aseptic manufacturing, single-use technologies, and manufacturing automation systems (DCS/PLC).
• Experience using statistical analysis and data-driven approaches to support manufacturing decisions. Knowledge of software-based statistical analysis tools is preferred.

Preferred Qualifications

• Experience with process monitoring and multivariate statistical analysis.
• Training or experience in Operational Excellence, Lean, Six Sigma, quality improvement methodologies, or project management.
• Demonstrated experience leading complex technical investigations and implementing corrective actions.
• Experience supporting regulatory inspections and compliance activities.