Downstream Processing Technician

Job Description

The Downstream Processing Technician will support the manufacture of Commercial and Clinical Biologics by performing operations in accordance with Current Good Manufacturing Practices (cGMPs). This role involves downstream processes such as purification and filtration/HPLC, including propagation of mammalian cell culture, aseptic cell culture operations, execution of large-scale production bioreactors, and conducting large scale filtration or centrifugation. The technician will also handle purification through large scale chromatography.

Responsibilities

• Review all area documents to ensure accuracy and compliance.
• Assist in the manufacture of controls and calibrators and complete batch records following cGMPs.
• Perform in-process assays using equipment such as spectrophotometers, pH meters, and clinical analyzers.
• Weigh, transfer, and mix chemicals as required.
• Perform product filtrations and maintain lab equipment including pumps, pH meters, and flow meters.
• Clean and steam steel tanks (CIP/SIP) and prepare glassware and steel tanks for sterilization in an autoclave.
• Monitor stocks of common lab supplies and keep department lead or manager updated on all issues.
• Participate in process improvement projects and respond to emergency notifications.
• Work flexible hours including weekends as needed.

Essential Skills

• Minimum of 2 years of work experience in manufacturing, operation, production, lab setting, or related field.
• Bachelor's Degree in a STEM-related field.
• Knowledge of cGMP practices and aseptic techniques.
• Experience with chromatography, HPLC, and chemical concepts.

Additional Skills & Qualifications

• Preferred: 6 months of experience in a GMP regulated environment.
• Preferred: Experience in a cGMP environment and a 4-year STEM degree.
• Subject Matter Expert on downstream processing steps.

Work Environment

The role requires working in a cleanroom/aseptic suite environment, with a rotating 12-hour day shift from 6:15am to 6:45pm. The schedule involves working 7 days out of a 2-week period, with specific days on and off. Full gowning is required, including bodysuit, gloves, hair & beard nets, face covers, and safety glasses. Candidates must be comfortable standing for 80% of the shift and able to lift a minimum of 25 lbs independently. Certain personal items such as makeup, jewelry, and scented products are prohibited in the cleanroom.