Sr. Upstream Processing Technician

Job Title:

Upstream Processing Technician

Job Description

The Upstream Processing Technician supports the manufacture of commercial and clinical biologic products by performing upstream cell culture operations in a cGMP-regulated cleanroom environment. This role focuses on large-scale mammalian cell culture, bioreactor operation, and associated filtration and centrifugation activities, while maintaining strict compliance with current Good Manufacturing Practices (cGMP) and aseptic techniques. The position offers hands-on experience with large-scale biological and chemistry pharmaceutical operations that produce proteins used in therapies for conditions such as autoimmune diseases.

Responsibilities

+ Execute manufacturing batch records, work instructions, and standard operating procedures (SOPs) with a strong focus on accurate, proactive, and 'right the first time' performance.

+ Assist with batch record reconciliation to ensure documentation completeness and accuracy.

+ Perform upstream cell culture operations, including propagation of mammalian cell cultures and aseptic handling of materials and equipment.

+ Operate large-scale production bioreactors ranging from 50L to 2000L for commercial and clinical biologic manufacturing.

+ Conduct large-scale filtration and centrifugation steps associated with upstream processing.

+ Support all department functions by maintaining production suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.

+ Document all activities in compliance with cGMP requirements, including completing reviews and revisions of records, daily task logs, and relevant databases.

+ Participate in and sometimes lead shift exchanges, one-on-one discussions, and team meetings, and attend additional meetings as needed to support area changes and continuous improvement (lean activities).

+ Support quality investigations by answering questions, providing process details, and suggesting improvements to prevent recurrence.

+ Promote and follow safe work habits, adhering to all safety procedures, guidelines, and site policies.

+ Critically evaluate processes, using foresight and forward-thinking to identify potential issues before they occur.

+ Prioritize tasks effectively by interpreting production schedules and completing work in alignment with manufacturing timelines.

+ Consistently meet cleanroom gowning and aseptic behavior requirements while performing duties in controlled environments.

+ Lift materials and equipment up to 25 pounds independently and stand for extended periods during production activities.

Essential Skills

+ Minimum of 2 years of work experience in manufacturing, operations, production, laboratory, or a related technical field.

+ High school diploma or equivalent.

+ Ability to apply practical knowledge to achieve successful outcomes in a production or laboratory setting.

+ Capability to recognize problems as they begin to develop, not only once they have fully occurred.

+ Strong critical thinking and problem-solving skills.

+ Solid math skills to support calculations related to cell culture, bioreactor operations, and solution preparation.

+ Proficiency with MS Office applications for documentation, data entry, and communication.

+ Ability to read, write, and communicate effectively in English.

+ Ability to understand and carry out written and verbal instructions accurately.

+ Ability to lift a minimum of 25 pounds independently.

+ Ability to stand for approximately 80% of the work shift.

+ Willingness and ability to meet cleanroom gowning requirements, including wearing full gowning suits, Tyvek garments, and appropriate gloves (Nitrile and/or Latex).

Additional

Skills & Qualifications

+ Bachelor's degree in a STEM-related field or in a scientific discipline such as biology, biochemistry, chemistry, or pharmaceutical sciences is preferred.

+ Experience in a cGMP-regulated environment is preferred.

+ At least 6 months of experience in a GMP-regulated environment and with aseptic techniques is preferred.

+ Knowledge of cGMP practices, aseptic techniques, and basic chemical concepts is preferred.

+ Subject matter expertise in upstream processing steps is a strong…