Lyophilization & Packaging Shift Lead

Lyophilization & Packaging Shift Lead Summit Works - 4.0 Naperville, IL Job Details Full-time $20 - $40 an hour 4 hours ago Benefits Health insurance Paid time off Qualifications Biochemistry

ICH Q7 FDA 21 CFR

Part 11 GMP Manufacturing facility ICH guidelines Chemistry Associate's degree Pharmaceutical manufacturing facility experience Full Job Description Position summary The Lyophilization and Packaging Shift Lead is the on-floor technical authority for freeze-drying and final-API packaging during their assigned shift at Summit Works USA. With two shifts running, there is a Day-shift lead and an Evening-shift lead. Because lyophilization cycles run twenty-six to thirty hours, structured handoff of in-process cycles across shifts is a core responsibility, as is the controlled-atmosphere packaging of released bulk API. Key responsibilities The Shift Lead completes the pre-cycle checklist (chamber cleanliness, sensor calibration, leak test, cycle-recipe version, condenser pre-cool), confirms pre-lyophilization bulk-solution analytics are released, and verifies any injectable-grade testing where applicable. They supervise filling and loading (fill-weight verification on the first and last units, thermocouple placement, chamber seal within thirty minutes), monitor freeze, primary, and secondary drying for the portion of the cycle on their shift, document deviations in real time, and escalate any approach to collapse temperature or pressure/condenser excursion. In-process cycles crossing the shift boundary get a documented, structured turnover. On the packaging side, the Shift Lead runs fill of bulk API into HDPE amber bottles across the 10 g to 1000 g range under the controlled atmosphere and relative-humidity conditions specified for the product's risk tier, supervises label control and container-closure, and documents fill weights and reconciliation. The Shift Lead reviews batch records contemporaneously, performs shift-end review, and directly supervises, trains, and evaluates the lyophilization and packaging operators on their shift. Required qualifications A Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, or a related field, or an Associate's with significant relevant experience, plus at least three years of hands-on lyophilization experience and at least one in a cGMP environment. Knowledge of cycle phases, the collapse-temperature concept, Pirani versus capacitance-manometer endpoint logic, and basic controlled-atmosphere packaging is required, with strong

ALCOA+, 21 CFR

Part 11, and ICH Q7 knowledge. Preferred qualifications Prior shift-lead experience in a bulk peptide lyophilization suite is strongly preferred; familiarity with annealing cycles, eutectic-temperature determination, and isolator or controlled-RH packaging is desirable. Physical requirements and working environment On-site, shift-based; the two openings cover the Day and Evening shifts, with off-shift response possible during validation or campaigns. PPE including cold-rated gear for cold-room work and face shield for tray transfer; standing, lifting to fifty pounds, and cold-room work near four degrees Celsius.

Pay:

$20.00 - $40.00 per hour

Benefits:

Health insurance Paid time off

Work Location:

In person