Title: Lead Scientist, Upstream Process Development
Work Location: Alachua, FL
Division: Pharma Services Group (PSG)

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

The Lead Scientist will work on large-scale cell culture-based activities in the Process Development Laboratory to provide our clients with the highest quality processes and products. Responsibility will involve seed train processes and large-scale bioreactor production. Will work closely with Assistant Director Upstream PD and PD Supervisors in the design, modification and scale-up of processes to ensure their successful transfer to cGMP compliant manufacturing and scalability. This position will provide expertise, to trouble-shoot, identify and implement improvements to existing processes. Will help in the planning and scheduling of production campaigns. This position will write, review, and ensure issuance of new or revised documents, as well as review, and approve executed required documentation including Process Development Production Records (PDPRs), standard operating procedures (SOPs), planned variances, deviations, etc. when necessary and respond to QA audits in a timely manner. The incumbent will work closely with the Downstream Process Development group, the Upstream GMP Manufacturing, other Manufacturing units, Supply Chain, Facilities, Project Management, Quality Assurance and Quality Control units.

What will you do?

• Perform Upstream small- and large-scale process development activities.
• Maintain laboratories and production rooms according to the companies’ high compliance standards including review of executed records, equipment logbooks and maintenance records.
• Identify and implement various efficiency improvements for processes and equipment.
• Provide expertise for equipment and processes within functional responsibility and assist in the equipment/process transfer to cGMP Manufacturing.
• Conduct technical investigations of production runs, determine root cause and provide solutions to various issues in upstream process development.
• Document investigation and solutions in investigation reports.
• Communicate experiment and production schedule, as well as cell culture standard procedures and safety rules to trainees, if assigned, and other team members.
• Oversee, hands-on, critical production activities to ensure appropriate and compliant execution. 
• Train and evaluate subordinate performance.
• Prepare status and development/production reports, participate in daily and/or weekly team meetings, and communicate issues and progress to the Assistant Director.
• Organize and report production outcomes for Upstream Process Development production activities, to ensure that process and project objectives are achieved in a timely manner.
• Maintain various cell lines for process development purposes, process scale up and non-GMP toxicological lots.
• Participate in the development and/or optimization and implementation of new processes in the Upstream PD laboratory.
• Write and/or revise PDPRs, SOPs and RMS.
• Maintain proper record of materials used for experiments and bank productions.
• Source cGMP compatible raw materials for processes.
• Assist in the sourcing, purchase, installation, startup and calibration and maintenance of Upstream Process Development equipment.
• Ensure that the production rooms operate efficiently (schedule; material staging, environmental monitoring, and facilities cleaning, maintenance, calibration) and all activities are appropriately documented.
• Interact with FB Supply Chain Manager and when necessary, vendors (raw materials, equipment, and reagent supplies, validation, calibration and maintenance activities through the Facilities Department. or independently) on a regular basis to discuss needs and requirements including supply availability, delivery and installation timelines, etc.
• Assist in evaluating and implementing short and long-term scheduling, staffing, planning for Upstream Process development.
• Assist in obtaining proper equipment in order to keep pace with increases and changes in production requirements relative to throughput, efficiency, and advances in technology.
• Work in collaboration with Quality Assurance, Quality Control, Manufacturing, Supply Chain, Facilities and Project Management to achieve the departmental goals and objectives. Other assigned duties

How will you get here?

A Bachelor’s degree in an area of specialization and three years of appropriate experience. Appropriate college coursework may substitute at an equivalent rate for the required experience or exempt by Manager’s approval.

Preferred:

Master’s or Ph.D. degree in Genetics, Chemical Engineering, with experience in large scale (> 100L) upstream production using mammalian and /or insect cells, with knowledge of DoE and statistics. In-depth understanding of cell biology, including aseptic manipulations in a cleanroom environment is desirable. Working knowledge of modern laboratory procedures, virology is a plus. Supervisory experience a plus.