Production Chemist

Production Process Chemist (Contract) | Peptide Manufacturing & GMP Operations Overview

We are seeking a Production Process Chemist to provide hands‑on technical support for commercial peptide manufacturing operations within a regulated biotechnology environment. This is an excellent opportunity for a chemist or process professional looking to gain extensive exposure to GMP manufacturing, process validation, technology transfer, equipment qualification, and commercial‑scale peptide production. In this highly collaborative role, you will partner with Manufacturing, Process Development, Quality Control and Quality Assurance teams to support production activities, troubleshoot manufacturing challenges, investigate deviations, and ensure compliance with cGMP standards.

The ideal candidate is technically strong, detail‑oriented, and thrives in a fast‑paced manufacturing environment.

• Provide floor‑side technical support for commercial peptide manufacturing operations, including:
• Solid-Phase Peptide Synthesis (SPPS)
• Peptide cleavage
• Purification processes
• Lyophilization (freeze drying)
• Partner with Manufacturing, Process Development, QA and QC teams to support routine production and continuous improvement initiatives.
• Support technology transfer activities to successfully implement new and optimized manufacturing processes.
• Assist with deviation investigations, root‑cause analysis, and quality system documentation.
• Support CAPA (Corrective and Preventive Action) activities through data collection, analysis, and documentation.
• Execute and document process validation activities, including:
• Process Performance Qualification (PPQ)
• Continued Process Verification (CPV)
• Support equipment qualification activities, including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Monitor manufacturing processes, analyze production trends, and identify opportunities for process improvements.
• Review batch records and manufacturing documentation to ensure accuracy, completeness, and cGMP compliance.

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, Bioengineering, or a related scientific discipline.
• Experience working in a cGMP-regulated pharmaceutical, biotechnology or life sciences manufacturing environment.
• Knowledge of peptide manufacturing processes, including:
• Solid‑Phase Peptide Synthesis (SPPS)
• Purification
• Cleavage
• Lyophilization
• Experience supporting process validation activities such as PPQ and CPV.
• Experience supporting equipment qualification activities including IQ, OQ and PQ.
• Understanding of deviation investigations, root‑cause analysis and quality systems.
• Experience supporting CAPA programs and documentation.
• Strong technical writing and GMP documentation skills.
• Excellent troubleshooting, analytical and problem‑solving abilities.
• Strong communication skills and ability to work cross‑functionally.
• Willingness to spend significant time supporting operations on the manufacturing floor.

• Prior peptide manufacturing experience.
• Experience supporting commercial pharmaceutical or biotechnology manufacturing operations.
• Familiarity with technology transfer projects.
• Experience working within formal quality systems and regulatory environments.
• Demonstrated ability to manage multiple priorities in a fast‑paced production setting.

This is a 3-month contract opportunity supporting a leave of absence. The role operates on a Monday–Friday, 8:00 AM–5:00 PM schedule and is heavily focused on manufacturing floor support within a cGMP-regulated production environment.

The position offers valuable hands‑on exposure to:

• Commercial peptide manufacturing
• GMP production operations
• Process validation
• Equipment qualification
• Technology transfer activities
• Quality systems and compliance programs

This role is ideal for a chemist, process scientist, manufacturing scientist, or process engineer seeking hands‑on experience in commercial biotech manufacturing and looking to expand their expertise in peptide production, GMP operations, validation and technical manufacturing support.