Sr. 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.

• 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 clean rooms, following gowning and contamination control procedures.

• 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.

• 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.

This role operates in cleanroom and aseptic suites,…