Lead Manufacturing Laboratory Technician - mAbs

Role Summary

The Lead Manufacturing Laboratory Technician (LT) in Lincoln, NE will facilitate a GMP biomanufacturing environment for monoclonal antibody production, guiding the Down Stream Team (DSP) to own their processes and uphold a scientific, safety-conscious culture. The LT provides guidance and training on the manufacturing floor, supports batch scheduling, batch records review, troubleshooting, and batch release as needed to meet production needs. The LT maintains GMP compliance, including SAP, validates batch records, and implements CAPAs; assists with deviations and floor investigations as required. The LT spends the majority of time actively participating in process operations, monitoring GMP, and escalating on-floor issues, while upholding site safety policies. The LT reports directly to the manufacturing Team Leaders.

Responsibilities

• Perform processes and operate equipment required for large-scale monoclonal antibody (mAb) production campaigns.
• Ensure the daily manufacturing activities are performed and recorded under GMP compliance and per defined schedule.
• Support the team members during daily activities and coach/mentor individual as needed.
• Responsible of ensuring area cleans follow required schedule.
• Review batch records daily and the logbook weekly for the assigned area.
• Train team members on the process and sign-off the completion of the on-job training document
• Support the team in trouble-shooting process issues when applicable.
• Monitor daily the batch performance through evaluation of key parameters.
• Responsible of the on-call phone during off hours (USP activities)
• Responsible of submitting work-order for the assigned areas
• Coach colleagues on GMP documentation and ensure team compliance during execution of the batch.
• Act as a liaison between the team and the Team Lead
• Understand, follow, and complete process documentation in support of GMP.
• Ensure safety shower and eye wash station flush is maintained per required schedule.
• Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.

Qualifications

• Required: Minimum of 2 to 4 years of experience in biomanufacturing setting; Preference given to applicants with relevant experience in mAb production.
• Required: Excellent communication skills and attention to detail.
• Required: Ability to prioritize work, think critically, and take initiative.
• Required: Ability to work well in a team environment as well as work independently with minimal supervision when needed.
• Preferred: Previous experience in large-scale production or laboratory scale.

Education

• BS in Biological sciences or a related field is required; MA/MS preferred.

Skills

• Read and follow written directions.
• Communicate effectively both verbally and in writing.
• Think critically.
• Function independently when required.
• Resolve conflict.
• Train colleagues and lead colleagues.
• Understand the mAb manufacturing process (USP, DSP, or both).
• Basic computer skills (Word and Excel).
• Proficiency in SAP.
• Ability to troubleshoot.
• Knowledge in GMP environment.
• Knowledge in LIMS and MODA.
• Knowledge in DeltaV.
• Process fundamental understanding.

Additional Requirements

• Exposure to chemicals, fumes, odors, noise, live steam, temperature fluctuations, biohazards, continuous standing and lifting to a maximum of 50 lbs.