Scientist

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

Scientist
Kelly® is looking for a Scientist to work at a premier pharmaceutical industry leader in Irvine, CA. Let us help you grow at work and discover the next step in your career, all while being a vital part of your community.

Pay: $30.00–$36.00 per hour

Shift: 1st

What’s a typical day as Scientist? You’ll be:

• Supporting analytical method development, validation, and transfer for drug product development, including formulation, stability, and release testing.
  
• Validating and verifying new or existing USP methods; writing and reviewing validation/verification protocols, reports, and SOPs.
  
• Conducting method improvements and modifications for commercial or new products and troubleshooting instrument or analytical issues for raw materials and finished products.
  
• Maintaining excellent documentation for lab notebooks, logbooks, validation and verification reports, stability studies, lot release testing, and R&D protocols.
  
• Operating and maintaining analytical instrumentation such as HPLC, GC, ICP, UV, FTIR, dissolution testers, Malvern Particle Analyzers, and XRD.
  
• Analyzing organic and inorganic compounds to determine chemical and physical properties.
  
• Supporting method development, validation, transfer, and feasibility studies for drug products.

This job might be an outstanding fit if you:

• Possess a Bachelor’s degree (B.S. or higher) in Chemistry, with two or more years of relevant experience in the pharmaceutical industry (small molecules) or equivalent combination of education and experience.
  
• Have hands-on experience developing and validating analytical methods using HPLC and/or GC for assay, impurity analysis, residual solvents, and dissolution.
  
• Demonstrate proficiency in documentation practices and cGMP compliance, with prior experience supporting CMC documents for ANDA filing (preferred).
  
• Are skilled in using Empower software and operating a range of analytical instruments.
  
• Communicate effectively in English (verbal and written) for clear documentation and project updates.
  
• Possess strong analytical and mathematical skills, including statistical analysis, method validation, and interpretation of scientific data.
  
• Are self-motivated, capable of working independently, and able to prioritize and implement work with minimal supervision.
  
• Have experience with FDA audits for cGMP compliance (desirable).