Upstream Processing Technician

Job Description

The Upstream Processing Technician supports the manufacture of commercial and clinical biologics by performing upstream (cell culture) operations in a regulated cleanroom environment. This role follows Current Good Manufacturing Practices (cGMP) and focuses on mammalian cell culture, large-scale bioreactor operations, and associated filtration or centrifugation activities. The technician contributes directly to the production of biologic materials used in pharmaceutical products, gaining valuable experience in large-scale biological and pharmaceutical manufacturing.

Responsibilities

• Execute manufacturing batch records, work instructions, and standard operating procedures (SOPs) with a strong focus on proactive, right-first-time performance.
• Assist with batch record reconciliation to ensure complete, accurate, and compliant documentation.
• Support all department functions, including maintaining production suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
• Document all activities in compliance with cGMP requirements, including timely and accurate completion of records, forms, and logs.
• Perform daily document and record reviews, complete assigned tasks, and update relevant databases as required.
• Participate in or lead shift exchanges, one-on-one discussions, and team meetings to ensure effective communication of area needs and process changes.
• Engage in lean activities and continuous improvement efforts to enhance operational efficiency and quality.
• Support quality investigations by providing detailed information, answering questions, and suggesting process improvements.
• Practice and promote safe work habits by adhering to all safety procedures and guidelines.
• Evaluate processes proactively, using foresight and critical thinking to identify and mitigate potential issues.
• Interpret production schedules, prioritize tasks appropriately, and complete work according to established timelines.
• Perform upstream cell culture operations, including propagation of mammalian cell cultures under aseptic conditions.
• Execute large-scale production bioreactor operations in the 50L to 2000L range, following defined procedures.
• Conduct large-scale filtration or centrifugation steps associated with upstream processing while maintaining aseptic technique.
• Maintain a clean and organized work area within aseptic suites and cleanrooms, following gowning and contamination control procedures.

Essential Skills

• Minimum of 2 years of work experience in manufacturing, operations, production, laboratory setting, or a related field.
• Ability to work in a cleanroom environment and follow aseptic techniques.
• Basic understanding of laboratory practices, including aseptic technique, cell culture handling, and pipetting.
• Ability to accurately follow cGMP documentation practices and complete batch records and SOP-driven tasks.
• Capability to interpret production schedules and manage task prioritization in a dynamic environment.
• Strong attention to detail and commitment to right-first-time execution.
• Ability to lift a minimum of 25 pounds independently.
• Ability to stand for approximately 80% of the shift.
• Willingness and ability to meet cleanroom gowning requirements, including wearing full body suits, gloves, hair and beard nets, face covers, and safety glasses.

Additional Skills & Qualifications

• Preferred: At least 6 months of experience in a GMP-regulated environment.
• Preferred: Bachelor’s degree in a science or STEM field, particularly with experience in aseptic technique, cell culture, and pipetting.
• Preferred: Experience in the pharmaceutical or pharmaceutical manufacturing industry.
• Preferred: Experience with mammalian cell culturing and bioreactor operations.
• Preferred: Knowledge of cGMP practices, aseptic techniques, and basic chemical concepts.
• Preferred: Subject matter expertise in upstream processing steps.
• Interest in large-scale biological and chemistry-based pharmaceutical operations.
• Motivation to contribute to the production of biologics such as large-scale antibodies used in therapies for conditions like autoimmune diseases.

Work Environment

This role operates in cleanroom and aseptic suites, where strict contamination control and gowning procedures apply. Team members work on a day shift schedule from approximately 6:00 a.m. to 4:30 p.m., following rotating 10-hour shifts that total 40 hours per week. A typical two-week rotation may include working Monday through Wednesda