About The Position
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.
Requirements
- High school degree or equivalent is required.
- Ability to read and follow written directions.
- Ability to complete basic calculations.
- Ability to think critically.
- Basic mechanical skills
- Ability to troubleshoot.
- Knowledge of the metric system
Nice To Haves
- Bachelor's or master's degree preferred.
- 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.
- Relevant experience in biological production, aseptic manufacturing, or in a regulated environment.
- 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.
Responsibilities
- Perform processes and operate equipment required for large-scale monoclonal antibody (mAb) production campaigns.
- 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
Benefits
- $500 Sign on Bonus
- 4 weeks accrued paid vacation and 13 paid holidays.
- 401(k) match with company profit sharing.
- Tuition reimbursement and Student Loan repayment program.
- Great Health, personal, and family benefits starting day 1.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
