Manufacturing Laboratory Technician - mAbs Swing Shift 8-hours (Monday - Friday and Rotating Weekends) 10:30am - 7:00pm

Job title: Manufacturing Laboratory Technician - mAbs Swing Shift 8-hours (Monday - Friday and Rotating Weekends) 10:30am - 7:00pm

Position Summary

The Manufacturing Technician in the mAbs Department works in a GMP manufacturing laboratory environment for monoclonal antibody (mAb) production, executing both upstream and downstream operations. The role performs hands-on work using aseptic technique and GMP practices while following approved SOPs and batch records. Upstream responsibilities include aseptic technique, inoculation and seed train support, mammalian cell culture maintenance, feeding and sampling, monitoring, and documenting critical process parameters, and operating culture equipment (e.g., bioreactors and associated systems) as required. Downstream responsibilities include harvest activities and purification operations such as centrifugation, chromatography, ultrafiltration, and nanofiltration, along with equipment setup, cleaning, and changeovers. The technician ensures compliance and product quality through accurate, timely documentation, adherence to safety protocols for biological materials, chemicals, and equipment. Hours: Swing Shift, 10:30am - 7:00pm (8-hours) Monday - Friday and rotating weekends. Overtime and holidays may be required.

Position Responsibilities

• Support large-scale GMP biologics production campaigns by performing upstream and downstream manufacturing operations, including:
• Aseptic inoculation, expansion, and cultivation of mammalian cell cultures across multiple scales (e.g., seed train through production)
• Operation and monitoring of bioreactors, isolator gloveboxes, and associated automated manufacturing equipment.
• Execution of equipment cleaning-in-place (CIP) and steam-in-place (SIP) procedures in accordance with SOPs and batch records
• Perform chromatography, ultrafiltration (UF), and nanofiltration (NF), as required by the process.
• Inventory management for materials and consumables (receipt, staging, reconciliation), and sampling in support of in-process testing and release requirements.
• Perform routine equipment maintenance and troubleshoot issues as needed
• Accurately complete and maintain process documentation in compliance with GMP standards to ensure product quality
• Adhere to all safety policies and procedures related to biological and chemical handling, as well as equipment use
• Collaborate effectively with cross-functional teams and other departments to support production goals

Education and Experience

• High school degree or equivalent is required. Bachelor's or master's degree preferred.
• The ideal candidate would possess:
• BS in Biology, Chemistry, Biochemistry, Biotechnology, or a related field
• Previous experience in large-scale production or laboratory scale
• Excellent communication skills and attention to detail
• Ability to prioritize work, think critically, and take initiative.
• Ability to work well in a team environment as well as work independently with minimal supervision when needed.
• Preference will be given to candidates with relevant experience in biological production, aseptic manufacturing, or in a regulated environment.

Technical Skills and Competencies Required

• Functional skills:

• Ability to read and follow written directions.

• Ability to complete basic calculations.

• Ability to think critically.

• Technical skills:

• Basic mechanical skills

• Ability to troubleshoot.

• Knowledge of the metric system

• Desirable skills:

• Mammalian cell culture practices and techniques

• Fundamental understanding of bioreactors/fermenters or downstream purification techniques

• Basic understanding of biological and chemical principles

• Experience with Outlook, Excel, and Word

• Experience within a regulated environment.

Physical Position Requirements

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