Cleavage & Precipitation Shift Lead

Cleavage & Precipitation 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 Cleavage and Precipitation Shift Lead is the on-floor technical and supervisory authority for TFA cleavage and crude isolation during their assigned shift at Summit Works USA. With two shifts running, there is a Day-shift lead and an Evening-shift lead, each responsible for safe cocktail preparation, controlled cleavage, dropwise precipitation, ether washing, and the drying and weighing that yield the crude peptide handed to QC. Key responsibilities The Shift Lead verifies the MPCR-specified cocktail composition, performs or witnesses dual-verified weighing of each component, records volumes and ratios contemporaneously, and ensures the cocktail is prepared fresh in a functioning fume hood by personnel in acid-resistant PPE. They supervise the cleavage reaction — timing from documented start, watching temperature and any anomalous color change, ensuring complete filtration and resin washing — and are the in-the-moment authority on extending cleavage time, escalating any non-standard step to the Manager and Quality Unit first. They oversee precipitation (confirmed cold-solvent temperature, dropwise addition, stirring profile, centrifugation or filtration, and each ether wash), weigh the dried crude, record crude mass and yield, and flag any yield outside the MPCR alert limit. They manage the representative aliquot and chain-of-custody handoff to QC and relay results to the Manager and the Purification Shift Lead. The Shift Lead reviews batch records contemporaneously, performs shift-end open-record review, runs a structured turnover, and directly supervises, trains, and evaluates the cleavage operators on their shift. Required qualifications A Bachelor's degree in chemistry, biochemistry, or a related field, or an Associate's with significant relevant experience, plus at least three years of hands-on TFA cleavage and crude-isolation experience and at least one in a cGMP environment. Knowledge of cocktail design, scavenger function, and principal side products is required, with strong

ALCOA+, 21 CFR

Part 11, and ICH Q7 knowledge and demonstrated independent supervision on shift. Preferred qualifications Prior shift-lead experience in a peptide cleavage suite is strongly preferred; anhydrous HF cleavage experience (for portfolio expansion) and familiarity with alternative crude-isolation approaches are desirable. Physical requirements and working environment On-site, shift-based; the two openings cover the Day and Evening shifts. Acid-resistant PPE (gloves, face shield, apron, acid-rated boots) during cleavage and precipitation; standing, walking the suite, lifting to fifty pounds, and tolerance of ether and TFA odors at facility limits.

Pay:

$20.00 - $40.00 per hour

Benefits:

Health insurance Paid time off

Work Location:

In person