Principal Process Chemist - Peptide Focus

About the role

CordenPharma is seeking a highly skilled and experienced Process Chemist to lead the development and GMP manufacturing processes in the area of peptide manufacturing. The ideal candidate will have a PhD in Organic Chemistry/Biochemistry with extensive experience in peptide chemistry, including SPPS, LPPS, and fragment synthesis. They should also possess strong knowledge of Quality by Design (QbD) principles, ICH guidelines, and current Good Manufacturing Practices (cGMP).

Responsibilities

• Ensures chemistry meets cost, yield, throughput, and QSHE goals on assigned processes in GMP plant production.
• Develops and supports scalable peptide processes and provides technical expertise and support during lab and GMP plant operations.
• Develops and executes procedures, processes, and methods for solutions to chemical and technical problems on lab and/or plant scale.
• Conducts research and development to improve manufacturing processes, improve costs profile, and process yield and throughput.
• Collaborates closely with Analytical Development, Manufacturing, QA, Regulatory, and external partners.
• Provides expert input on project timelines, risks, and mitigation strategies.
• Adheres to GDP and SOPs in all aspects of work.

Qualifications

• Doctoral Degree (PhD) in Organic Chemistry/Biochemistry with strong expertise in Peptide Chemistry (SPPS, LPPS, Fragment Synthesis), plus 5 years of industrial experience ideally at a CDMO; or equivalent combination of education and experience.
• Proven track record in developing manufacturing processes suitable for large scale production > 100 kg.
• Strong knowledge in working in multidisciplinary teams during tech transfer.
• Experience with ICH guidelines, GMP, and regulatory CMC expectations.