Peptide Chemist (GMP Production)

Discover International; Cape Coral (FL); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Discover International in Southwest Florida is seeking a hands-on chemist to join our GMP peptide synthesis team. You'll synthesize peptides via SPPS, purify by HPLC, document batch records, and support validation activities as we build GMP capabilities for clinical programs.

The ideal candidate has 4–8 years of peptide synthesis experience in a GMP environment, strong documentation habits, and a chemistry degree (BS/MS/PhD). US work authorization is required; visa sponsorship is not available.

Qualifications

• 4–8 years’ hands-on peptide synthesis in a GMP environment.
• Practical experience with prep HPLC purification of peptides.
• Strong GMP documentation habits: batch records, deviations, root cause analysis, change controls.
• Exposure to process and cleaning validation, plus CMC writing.
• BS, MS or PhD in Chemistry or a related field.
• Must be authorized to work in the US. Visa sponsorship is not available.

Responsabilités

• Run GMP synthesis of peptides by solid-phase peptide synthesis (SPPS), including cleavage and work-up
• Purify peptides by preparative HPLC, then lyophilize and package them
• Execute, and help write, master and executed batch records
• Support process validation and cleaning validation activities
• Own deviations, root cause investigations, CAPAs and change controls
• Contribute to CMC documentation for regulatory filings
• Work closely with R&D peptide chemistry, analytical and QA teams

Connaissances

GMP documentation

Root cause analysis

Change controls

Synthesis expertise

Formation

BS/MS/PhD in Chemistry

Outils

Prep HPLC

Description du poste

A clinical-stage oncology biotech in Southwest Florida is growing its in-house peptide manufacturing team. The company develops targeted peptide-based agents for cancer imaging and therapy, and is building GMP capability to supply its clinical programs.

This is a hands-on production role for a chemist who enjoys running well-controlled processes and documenting them properly: synthesize, purify, document and repeat, to a high standard.

What you’ll do

• Run GMP synthesis of peptides by solid-phase peptide synthesis (SPPS), including cleavage and work-up
• Purify peptides by preparative HPLC, then lyophilize and package them
• Execute, and help write, master and executed batch records
• Support process validation and cleaning validation activities
• Own deviations, root cause investigations, CAPAs and change controls
• Contribute to CMC documentation for regulatory filings
• Work closely with R&D peptide chemistry, analytical and QA teams

What we’re looking for

• 4–8 years’ hands‑on experience in peptide synthesis in a GMP environment, ideally at a peptide manufacturer, CDMO or biotech
• Practical experience with prep HPLC purification of peptides
• Strong GMP documentation habits: batch records, deviations, root cause analysis, change controls
• Exposure to process and cleaning validation, plus CMC writing
• BS, MS or PhD in Chemistry or a related field
• Must be authorized to work in the US. Visa sponsorship is not available.