Position summary
The Synthesis Shift Lead is the on-floor technical and supervisory authority for SPPS operations during their assigned shift at Summit Works USA. With the operation running two shifts, there is a Day-shift lead and an Evening-shift lead; both run the synthesis schedule across the Liberty PRO fleet, supervise their operators, perform dual-verification at every dispensing step, and ensure every batch-record entry meets ALCOA+ before handoff. The Shift Lead is first responder to any in-process anomaly and first decision-maker on whether a batch continues or pauses for Quality Unit consultation.
Key responsibilities
The Shift Lead completes line clearance and the pre-manufacturing checklist at the start of each batch on shift — verifying APPROVED labels, lot-number matches to the MPCR, synthesizer cleanliness and qualification, and current training of assigned personnel — and signs off before synthesis begins.
Dual-verification at point of dispensing is non-delegable: for every weighing and addition into a synthesis vessel, the Shift Lead serves as independent witness, confirming identity, lot, APPROVED status, and mass against the MPCR, co-signing each entry, and stopping the operation on any out-of-tolerance discrepancy.
The Shift Lead runs or supervises the Kaiser test at every coupling cycle, authorizes the standard single repeat coupling on a positive result, and escalates a persistent failure to the Synthesis Manager and Quality Unit. They monitor microwave power, temperature, pressure, and nitrogen delivery in real time and intervene on any CPP deviation.
The Shift Lead reviews batch records contemporaneously through the shift, performs a shift-end review of all open records, and conducts a structured turnover to the incoming shift documenting open items and watch points. They directly supervise, train, and evaluate the synthesis operators on their shift.
Required qualifications
A Bachelor's degree in chemistry, biochemistry, or a related field is required, or an Associate's degree with significant relevant experience, plus at least three years of hands-on SPPS experience and at least one in a cGMP environment. Working knowledge of Fmoc SPPS, microwave-assisted coupling, Kaiser test interpretation, and dual-verification dispensing is required, along with strong ALCOA+, 21 CFR Part 11, and ICH Q7 knowledge and demonstrated ability to supervise operators and decide independently on shift.
Preferred qualifications
Prior shift-lead or floor-supervisor experience in pharmaceutical or peptide manufacturing is strongly preferred, as is direct experience with CEM Liberty Blue or Liberty PRO platforms and contribution to deviation investigations.
Physical requirements and working environment
On-site, shift-based; the two openings cover the Day and Evening shifts, with rotating or weekend coverage as the schedule requires. PPE throughout the shift, standing and walking the floor continuously, and intermittent lifting to fifty pounds.
Pay: $20.00 - $40.00 per hour
Benefits:
- Health insurance
- Paid time off
Work Location: In person
