Pilot Plant Manager

Job Summary

Reporting directly to the Vice President of Biomanufacturing Development for the ETSU Research Corporation, the Pilot Plant Manager provides leadership across personnel management, research and development, engineering, automation, and the hands-on operation and maintenance of a small-scale manufacturing facility. The position oversees the planning, scheduling, staffing, and execution of pilot plant operations involving synthetic biology, industrial biomanufacturing, bioprocess development, scale-up and scale-down activities, and upstream and downstream processing. The Pilot Plant Manager is fully accountable for the safety, regulatory compliance, and operational excellence of the pilot plant at the ETSU Valleybrook Research Facility and will play a significant role in designing, planning, and operating future facilities. The position requires extensive hands-on experience and demonstrated leadership across GMP environments, including industrial fermentation and biotechnology facilities. The manager is also responsible for actively developing a customer base and advancing the pilot plant toward financially self-sustaining operations. Knowledge, Skills, and Abilities

• Knowledge of microbiological concepts, techniques, and methods, including the consistent application of sterile and aseptic techniques.
• Comprehensive knowledge of Good Manufacturing Practices (GMP), including safety, engineering, operations, personal protective equipment, automated safety interlocks, process validation, traceability, documentation, and standardized workflows.
• Knowledge of upstream and downstream bioprocessing technologies, including fermentation and downstream processing methods.
• Knowledge of process automation and control systems, including programmable logic controllers (PLCs), sensors, transmitters, signal transmission, wiring, pumps, valves, motors, steam systems, chillers, aeration systems, and pressure-containment systems.
• Knowledge of industrial safety practices, including confined-space entry, working at heights, lockout/tagout procedures, pressure systems, and hazardous-materials handling.
• Understanding of sensor calibration, scaling, ranging, and signal transmission.
• Expertise in microbial cell culture, fermentation, and bioprocessing using pilot- and industrial-scale fermenters and bioreactors.
• Experience operating pilot- or industrial-scale bioreactors and Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems.
• Skill in developing, adapting, and optimizing fermentation and downstream processing methods.
• Skill in reading and interpreting Process and Instrumentation Diagrams (P&IDs).
• Skill in diagnosing and troubleshooting equipment, processes, electrical signals, pumps, valves, sensors, automation systems, and microbial growth performance.
• Skill in safely using hand tools and power tools to support equipment operation and maintenance.
• Proficiency with standard computer applications, including Microsoft Word, Excel, PowerPoint, and Outlook.
• Skill in communicating complex technical and conceptual information clearly to technical and nontechnical audiences.
• Strong interpersonal skills and the ability to establish effective working relationships with employees, collaborators, customers, and other stakeholders.
• Skill in promoting a safe working environment through employee training and oversight, effective procedures, appropriate automation and safeguards, and timely intervention when unsafe conditions or performance concerns arise.
• Skill in addressing unsafe or unrealistic expectations appropriately and assertively.
• Demonstrated accountability, humility, and self-awareness, including a willingness to identify, discuss, correct, and prevent errors.
• Ability to design, execute, and evaluate scientifically sound experiments that support strategic research and operational objectives.
• Ability to translate strategic objectives into operational plans and activities using initiative, sound judgment, and critical thinking.
• Ability to ask questions, challenge assumptions, and recommend appropriate alternatives.
• Ability to respond constructively to setbacks, adapt to changing circumstances, and apply lessons learned to future work.
• Ability to maintain a reliable work schedule during regular operating hours and occasionally work outside standard hours when required by operational needs.

Required Qualifications

• Bachelor's degree in life science, biology, process engineering-related fields, or equivalent in depth of industrial experience.
• At least five (5) years of hands-on experience with industrial equipment operation, maintenance, and safety in a GMP environment.
• At least two (2) years of hands-on experience with pilot or industrial scale bioreactors and downstream processing equipment.
• At least two (2) years of experience as an operations leader in a factory setting including direct reports, hiring, and firing.
• US Citizenship is required.

Preferred Qualifications

• At least 1-year hands-on experience designing and executing microbial fermentation trials is preferred.
• Formulations and packaging experience preferred.

Physical Demands (as needed) *This is a physically demanding position requiring the ability to perform the essential functions of the job, with or without reasonable accommodation.

• Prolonged standing (e.g., up to 4+ hours)
• Sitting for extended periods (e.g., at a computer or workstation)
• Climbing stairs or ladders
• Crawling, kneeling, crouching
• Reaching overhead or below waist level
• Balancing on uneven surfaces
• Lifting objects up to 50 lbs
• Carrying files, equipment, or supplies short distances
• Pushing or pulling carts, furniture, or equipment
• Frequent typing or keyboard use
• Handling small tools or equipment
• Operating machinery or hand tools
• Visual acuity to read printed and electronic materials
• Hearing to distinguish sounds (e.g., phone calls, alarms)
• Speaking clearly in noisy environments
• Working in extreme temperatures (outdoor work, lab freezers, kitchens)
• Exposure to loud noises (e.g, machinery, crowd environments)
• Exposure to bodily fluids, hazardous materials, or fumes
• Working in confined spaces or high places
• Wearing protective gear (e.g., gloves, goggles, masks)
• Frequent bending or stooping
• Twisting torso or neck
• Repetitive wrist or arm movements
• Remaining in one position for extended periods

Compensation & Benefits

• Job Family – Operations Management 3
• Starting Salary: MR 12 Salary Schedules
• For information on benefits please visit www.etsu.edu/human-resources/benefits/.

Application Instructions

• Exempt positions are only required to be posted for a minimum of fourteen (14) calendar days. The closing date for this posting is subject to change without notice to applicants.
• Employment contingent on a satisfactory background check.

ETSU is an equal opportunity employer. University Overview East Tennessee State University (ETSU) is an institution with over 14,000 diverse students highly ranked graduate and undergraduate programs. Located in the Southern Appalachian Mountains of Northeast Tennessee, ETSU serves as a hub for community, discovery, and service. Aligned with the institution's mission, we value efforts to engage in teaching, scholarship, creative activities, and service that involve community partners and address significant societal needs in our region and beyond. Recognized in 2024 as a Great College to Work For, recent strategic initiatives prioritize the institution’s focus on community engagement. Disclaimer: The Job Summary is intended to describe the general nature and level of work individuals perform in this classification. It is not intended to be a complete list of all responsibilities, duties, and skills required. Management reserves the right to revise the job or require different tasks to be performed as assigned to reflect changes in the position. Employees must be able to perform the position's essential functions satisfactorily with or without reasonable accommodations.