Scientist II Pilot (all genders)

WhatYou’llDo:

• Pilot-Scale Operations & Execution:

• Prepare and run pilot scalesingle usebioreactors and related equipment, and provide operational support on bioreactor specifications, operation, process parameters

• Execute and support pilot-scale upstream unit operations, including bioreactor runs up to ~50 L, for engineering, scale-up, and material generation batches.

• Translate laboratory-scale upstream process parameters into pilot-scale execution under guidance, ensuring process robustness, reproducibility, and data integrity.

• Support pilot activities that bridge process development and cGMP manufacturing, including preparation for tech transfer.

• Study Support & Cross-Functional Collaboration:

• Collaborate closely with DSP pilot, USP development, Analytical, and Manufacturing teams to support pilot-scale material generation for process characterization, equipment qualification, and other material generation (e.g., toxicology, stability).

• Participate as an upstream pilot representative on cross-functional project teams, contributing to planning and execution aligned with project timelines.

• Facility & Operational Readiness:

• Support day-to-day pilot operations, including equipment setup, preparation, cleaning, and turnover.

• Ensure activities are conducted in compliance with safety, quality, and operational standards.

• Assistwith scheduling and readiness activities in coordination with senior team members.

• PilotOptimization & Technology:

• Collaborate in the technical definition of projects ofintroduction ofnew technologiesand equipment.

• Supportprocess improvement and process optimizationof intensified or advanced upstream processes, including the use of single-use systems and automation tools.

• Collect,analyze, review, and interpret pilot-scale process data to support process understanding and improvement.

• ConductkLa(oxygen transfer) studies to characterize bioreactor performance, assess mass transfer capabilities, and support process transfer across scales and equipment types. 

• Lead and contribute toscaleup activities, ensuring robust translation of upstream processes from laboratory/pilot scale to manufacturing scale using engineering principles (e.g.,kLa, P/V, tip speed, mixing time). 

• Evaluate new bioreactors, including characterization of hydrodynamics, mass transfer, mixing performance, and compatibility with existing upstream processes and facility constraints. 

• Documentation & Compliance:

• Accurately document pilot operations, process data, and observations in batch records, protocols, and reports.

• Author and review SOPs, protocols, and technical reports under guidance.

• Support deviation documentation and investigations as needed.

• Technical Contribution & Knowledge Sharing:

• Act as a technical contributor for upstream pilot execution, including scale-up principles and process control strategies.

• Support preparation of tech transfer documentation to manufacturing.

• Communicateclearly andeffectively with cross functional and externalstakeholdersaboutpilot studyobjectives, execution status, and results clearly to project teams and management.

• Training & Team Support:

• Mentor and supporttraining of junior staff and technicians on pilot-scale USP operations, safety practices, and standard procedures.

• Promote a strong culture of safety, data quality, and scientific rigor.

• Vendor & Equipment Support:

• Initiate andsupport interactions with equipment vendors and engineering teams for equipment setup, troubleshooting, and optimization.

Who You Are: 

• Master’sin engineering, Biochemistry, Biology, or related field with 5+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field.Bachelor's with more than 10 years of experience.

• ProficiencyinUSP(cell culture), protein chemistry, and bioprocess engineering 

• Hands-onexperience in pilot-scale bioreactor operations (10–200 L).

• Expertise inscale-up principles, process control, and data interpretation for both upstream and downstream processes.

• Experience supporting engineering batches, material generation, and technology transfer to cGMP manufacturing.

• Experience working in or supporting a cGMP or cleanroom environment(job isina non-GMPenvironment).

• Familiarity with process and equipment qualification (IQ/OQ/PQ).

• Understanding ofprocess safety and risk assessment principles in pilot-scale bioprocessing.

• Proficiencyin both verbal and written English is essential.

Pluses

• Experience in biosimilar orbiologicsdevelopment programs is an advantage.

• Experiencein productionof monoclonal antibodies is a plus

• Excellent attention to detail, able to stay organized and relaxed in complex situations while keeping track of multiple tasks and data.