Sr. Upstream Processing Technician

Upstream Processing Technician

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 include:

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

Essential skills include:

• 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 and qualifications include:

• 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 includes:

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 Wednesday and Saturday in the first week, followed by working Sunday and Wednesday through Friday in the second week, with designated days off in between.

The position requires full cleanroom gowning, including bodysuit, gloves, hair and beard nets, face covers, and safety glasses. To maintain aseptic conditions, items such as makeup, jewelry, nail polish, cologne or perfume, and scented lotions or hair care products are not permitted in the…