Analytical Development Lead – Small Molecule Drugs

Glaukos Corporation; San Clemente (CA); On-site; USD 97,900 - 122,400; Full time

Job summary

Glaukos Corporation is seeking a senior analytical development scientist to lead method development, validation, and transfer for small and large molecule programs. You will collaborate across cross-functional teams, oversee stability studies, and generate data for regulatory submissions.

The role requires expert knowledge in chromatographic techniques, QA/QC alignment, and experience with CRO/CMO interactions. A Ph.D. or MS in a relevant field with industry experience is preferred.

Qualifications

• Ph.D. (3+ years) or M.S. (8+ years) in analytical chemistry or related field.
• 3+ years of pharmaceutical industry experience in analytical development.
• Experience in small or large molecule analytics and regulatory support.

Responsibilities

• Design, conduct, and implement analytical activities for drug development.
• Troubleshoot technical challenges and generate high-quality data.
• Evaluate data from release and stability studies and draw scientific conclusions.
• Maintain expertise in assay technologies for drug delivery systems and testing.
• Prepare protocols and regulatory documents; support CMC sections of INDs/NDAs.
• Lead analytical aspects on CMC teams and transfer methods to QC.
• Develop and innovate analytical methods and technologies.

Skills

Analytical chemistry

Regulatory filings

Data interpretation

Cross‑functional collaboration

Problem solving

Communication

Education

Ph.D. in analytical chemistry or related field

M.S. in analytical chemistry or related field

Tools

HPLC

UPLC

GC

LC‑MS

UV/Vis

Dissolution

Job description

Glaukos Corporation is seeking a senior analytical development scientist to lead method development, validation, and transfer for small and large molecule programs. You will collaborate across cross-functional teams, oversee stability studies, and generate data for regulatory submissions.

The role requires expert knowledge in chromatographic techniques, QA/QC alignment, and experience with CRO/CMO interactions. A Ph.D. or MS in a relevant field with industry experience is preferred.