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.

Location/Division Specific Information

St. Louis, MO / Drug Substance

How will you make an impact?

The Manager's role is to oversee the upstream process engineering organization under the direction of the Senior Process Engineering Manager. The Manager is responsible for overseeing the technological quality and progress of the implementation and execution of the customer and technology projects within the Operations department beginning with the technology transfer of a molecule to the operations floor through the commercialization of a molecule and to the end of its life-cycle. The group will take a process that has been partially or fully developed and characterized and technology transfer the process and continue to run and support it from a manufacturing sciences perspective for the remainder of its life-cycle, including the continuous monitoring and improvement of the process over time. The group owns batch record creation/ updates, change controls, and CAPA related to the process to varying degrees, and supports deviation investigations from the Manufacturing Sciences/ Technical perspective. The group is responsible for modifying the process flow diagrams (PDF) for all programs, generating / modifying SOPs and job aids. Modifying good faith estimates and bill of materials (BOMs) for all client programs. Modifications to processes, equipment, and the driving the Quality Systems activities associated with such actions. The Manager is responsible for overseeing these activities and ensuring a positive customer interface.

What will you do?

• Provide the highest example of safety and quality mindedness in all job functions and instill this mindset in the teams you lead.
• Provide an atmosphere which fosters a questioning attitude, empowerment (appropriate to job level), and an error prevention/ continuous improvement mindset in all personnel.
• Oversee a team which will provide the framework to manufacturing for the optimal methodology to conduct standard unit operations for processes.
• Oversee the on time completion of documentation packages (drafted, reviewed and fully approved documents by Thermo Fisher Scientific and Client) for production scale processes, including
• Applicable SOPs
• Manufacturing Batch Records (MBR)
• PFDs including all disposable line builds for each program
• Campaign Summary reports and CPV reports and the actions and investigations driven by these
• Input into annual product reviews and filings as required
• Inform process development decisions with respect to facility fit and the manufacturability of development programs. Thereby, providing PD with the information required to develop fit for Suite/Site processes (i.e. raw material preferences, standard procedures, preferred operating methodologies)
• Oversee a team of highly trained biotechnology engineering experts to support the ongoing execution of manufacturing operations of clinical and commercialized processes.
• Identify good candidate actions to modify or improve procedures so as to stream line the activities of this position and maintain an optimal level of operational efficiency. Provide performance management and career coaching for direct and indirect reports

How will you get here?

Education

• Bachelor’s or Master’s in a scientific field, preferably chemical engineering, with ≥ 10 (BS), 8 (MS) or 6 (PhD) years of experience in a highly relevant field.

Experience

• Minimum of a total of four years of direct experience in technology transfer and/ or manufacturing technical support (i.e., process engineering) roles and/ or CPV support roles at the manufacturing scale in the biotech industry.

• Minimum of two years as a manager of staff. Experience indirectly marshaling those who do not report directly to you for action and completion of objectives.
• Extensive experience within the Biotech industry including an understanding of the regulatory requirements is required.

Knowledge, Skills, Abilities

• Detailed knowledge of GMP and other biopharmaceutical regulations from FDA, EU, and ICH guidelines.
• Demonstrated success in running multiple projects of high complexity.
• Expert knowledge of process development, process scale-up and cGMP manufacturing.
• Knowledge of the regulatory requirements.
• Proven success in conducting engineering tasks of high complexity.
• Proven success in interacting with customer preferred.
• Proven ability to form teams and produced desired results through direct and indirect reporting.

Supervision

• Will have direct reports, starting with approximately eight and expected to grow over the next several years.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.