Synthesis Operator

Synthesis Operator 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 GMP

Manufacturing standard operating procedures Manufacturing facility Laboratory standard operating procedures Chemistry Associate's degree Standard operating procedures (SOPs) Production records Laboratory record keeping Full Job Description Position summary The Synthesis Operator is the hands-on executor of solid-phase peptide synthesis at Summit Works USA. Running across two shifts, the Operator runs the CEM Liberty PRO synthesizers, performs dispensing, executes the wash and deprotection steps defined in the MPCR, runs the Kaiser test at every coupling cycle, and records every observation contemporaneously. The Operator is the first eyes on each coupling cycle and the source of the high-fidelity execution the rest of the pipeline depends on. Key responsibilities The Operator weighs raw materials on calibrated balances per the MPCR, presents each weighing to the Shift Lead for dual-verification, and transfers verified materials into the synthesis vessel only after both signatures are recorded. They prepare coupling solutions, deliver them to the synthesizer, and initiate the automated coupling cycle using the approved program for the peptide in production. The Operator monitors each cycle in real time — microwave power, temperature, pressure, and drain and wash completeness — and documents parameters contemporaneously. They sample resin and run the Kaiser test at every coupling cycle, record the result, and escalate any positive result to the Shift Lead immediately. At batch end, the Operator dries the peptidyl resin, supports the documented transfer to cleavage, and cleans the synthesizer and reagent vessels per the validated cleaning SOP, signing the cleaning record. Throughout the shift they keep the floor in line-clearance state, verifying

APPROVED

labels and lot numbers and raising any discrepancy to the Shift Lead. Required qualifications An Associate's degree in chemistry, chemical technology, or a related field is required, or a high-school diploma with substantial relevant laboratory experience, plus at least one year of hands-on laboratory experience (peptide synthesis or pharmaceutical manufacturing strongly preferred). The Operator must be able to follow an MPCR with full fidelity, record contemporaneously per ALCOA+, and work within a cGMP environment under ICH Q7. Training on the CEM Liberty PRO is provided. Preferred qualifications Prior SPPS experience, particularly on CEM Liberty Blue or Liberty PRO platforms, is preferred, along with any prior cGMP manufacturing experience. Physical requirements and working environment On-site, shift-based; the two openings cover the Day and Evening shifts. PPE throughout the shift, standing for the full shift, walking the floor, lifting to fifty pounds, fume-hood work, and careful use of analytical balances and glassware.

Pay:

$20.00 - $40.00 per hour

Benefits:

Health insurance Paid time off

Work Location:

In person