Job Title: Downstream Processing Technician

Job Description

The Downstream Processing Technician plays a crucial role in supporting the manufacturing operations of Commercial and Clinical Biologics. The technician will adhere to Current Good Manufacturing Practices (cGMPs) and perform a variety of downstream functions, including propagation of mammalian cell culture, aseptic cell culture operations, execution of large-scale production bioreactors, and large-scale filtration or centrifugation. Purification duties will involve large-scale chromatography, including column and HPLC techniques. The technician will manufacture buffers and simple bulk reagents with limited supervision and participate in process improvement projects.

Responsibilities

• Review all area documents.
• Responsible for the WNS.
• 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.
• Clean and steam steel tanks (CIP/SIP).
• Prepare glassware and steel tanks for sterilization in autoclave and operate the autoclave.
• Maintain lab equipment, including pumps, pH meters, and flow meters.
• Keep department lead or manager updated on all issues.
• Monitor stocks of common lab supplies.
• Perform other job duties as required.
• Respond to emergency notifications.
• Work flexible hours, including weekends.

Essential Skills

• Knowledge of cleanroom and aseptic techniques.
• Bachelor's Degree in Science with expertise in aseptic technique, chemistry, HPLC, and chromatography.
• Minimum of 2 years of work experience in manufacturing, operation, production, lab setting, or related field.

Additional Skills & Qualifications

• Preferred: 6 months experience in GMP regulated environment and aseptic technique.
• Preferred: Experience in a cGMP environment and a 4-year STEM degree.
• Knowledge of cGMP practices, aseptic techniques, or chemical concepts.

Work Environment

The work environment involves cleanroom and aseptic suites, requiring the willingness to gown up. The position operates on a day shift from 6:15 am to 6:45 pm, with rotating 12-hour shifts working 7 days out of a 2-week period. Technicians must be willing to wear full gowning suits, including bodysuits, gloves, hair & beard nets, face covers, and safety glasses. Restrictions on makeup, jewelry, nail polish, cologne/perfume, scented lotions, or hair care products apply. Ability to lift a minimum of 25 lbs independently and stand for 80% of the shift is required.