**Sr. Upstream Processing Technician**

This role supports the manufacture of commercial and clinical biologic products by performing upstream cell culture operations in a cGMP-regulated cleanroom environment. Focus areas include large-scale mammalian cell culture, bioreactor operation, and associated filtration and centrifugation activities, all while maintaining strict compliance with current Good Manufacturing Practices (cGMP) and aseptic techniques.

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.

Requirements

• 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).

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 plus.
• Experience with aseptic technique, cell culturing, pipetting, chromatography, and bioreactor operations is highly desirable.
• Background in biology, laboratory work, chemistry, chromatography, biochemistry, or the pharmaceutical industry is beneficial.

Work Environment

This position operates in cGMP-regulated cleanroom and aseptic suites where strict environmental and gowning standards apply. The role requires wearing full cleanroom gowning, including a bodysuit, gloves, hair and beard nets, face covers, safety glasses, and Tyvek garments, as well as Nitrile and/or Latex gloves. To maintain product and environmental integrity, items such as makeup, jewelry, nail polish, cologne or perfume, and scented lotions or hair care products are not permitted in the cleanroom.

The work involves standing for up to 80% of the shift and lifting up to 25 pounds independently. The environment is highly regulated, safety-focused, and collaborative, offering exposure to large-scale biologics and pharmaceutical manufacturing processes that contribute to important therapeutic products.

Schedule

Team members work rotating 10-hour shifts on either a day shift (approximately 6:00 a.m. to 4:30 p.m.) or a second shift (approximately 1:00 p.m. to 11:30 p.m.), with a schedule that includes working every other weekend. A typical two-week rotation may involve working Monday through Wednesday, being off Thursday and Friday, working Saturday, working Sunday, then being off Monday and Tuesday, followed by working Wednesday through Friday and being off Saturday.

Pay

The pay range for this position is $30.00 - $33.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)