Analytical Scientist – Drug Product Method Development

Mykelly; Irvine (CA); On-site; USD 41,000 - 50,000; Full time

Job summary

Mykelly is seeking a Scientist in Irvine, CA to support analytical method development, validation, and transfer for drug product development. The role involves validating USP methods, writing protocols and SOPs, and troubleshooting instrumentation to ensure robust assay performance.

The candidate should have a chemistry degree and 2+ years of pharmaceutical experience, with hands-on experience in HPLC/GC and a solid grounding in cGMP documentation.

Qualifications

• Bachelor’s degree in Chemistry with 2+ years pharma experience.
• Experience developing and validating analytical methods using HPLC/GC.
• Proficient in cGMP documentation and FDA/ANDA filing (preferred).
• Proficient in Empower software and instrumentation.
• Strong English communication and documentation skills.
• Able to work independently with minimal supervision.

Responsibilities

• Support analytical method development, validation, and transfer for drug product development.
• Validate USP methods; write validation/verification protocols, reports, and SOPs.
• Conduct method improvements and troubleshoot instrument or analytical issues.
• Maintain lab notebooks, validation reports, stability studies, and release testing docs.
• Operate and maintain HPLC, GC, ICP, UV, FTIR, dissolution testers, Malvern, and XRD.
• Analyze organic and inorganic compounds to determine properties.
• Support method development, validation, transfer, and feasibility studies for drug products.

Skills

HPLC

GC

ICP

UV

FTIR

Dissolution testing

XRD

Empower

Method development

cGMP compliance

Documentation

Education

Bachelor's in Chemistry

Tools

Empower software

Job description

Mykelly is seeking a Scientist in Irvine, CA to support analytical method development, validation, and transfer for drug product development. The role involves validating USP methods, writing protocols and SOPs, and troubleshooting instrumentation to ensure robust assay performance.

The candidate should have a chemistry degree and 2+ years of pharmaceutical experience, with hands-on experience in HPLC/GC and a solid grounding in cGMP documentation.