Lead Analytical Methods Scientist – Chromatography & R&D

Mix Talent; Grand Rapids (MI); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Mix Talent is seeking an R&D Principal Scientist to lead method development and qualification for liquid and gas chromatography, supporting drug products through early to late-stage development on site in Grand Rapids, MI. The role requires extensive HPLC/UPLC and GC experience and a strong track record in pharmaceutical analytical development.

You will oversee investigations, drive corrective actions, and support regulatory filings while serving as the subject matter expert during audits.

Qualifications

• Bachelor's degree in chemistry/biochemistry or related field with 15+ years of experience; advanced degrees preferred.
• Knowledge of USP, ICH and FDA requirements.
• Extensive experience with HPLC/UPLC, GC, and wet chemistry.
• Analytical method validation/development experience in the pharmaceutical industry.
• Experience investigating out-of-specification (OOS) or unexpected results.
• Experience in dissolution, IVRT/IVPT method development and validation.
• Experience in transdermal products preferred.

Responsibilities

• Plan, design, and oversee analytical method life-cycle activities through multiple stages of development.
• Accountable for qualification/validation, transfer of chromatographic and physical methods for testing.
• Contribute expertise on data interpretation, instrumentation, and troubleshooting.
• Track analytical method performance and implement remediation measures from early data signals.
• Support laboratory root cause investigations (OOS/OOT).
• Contribute to stability and comparability study design.
• Support of CMC regulatory filings.

Skills

Analytical method development

Chromatography (HPLC/UPLC, GC)

Regulatory filings support

Data interpretation & troubleshooting

Method validation

Education

Bachelor’s degree in chemistry/biochemistry or related field

Master’s degree in related field

PhD in related field

Tools

HPLC/UPLC

GC

Wet chemistry techniques

Job description

Mix Talent is seeking an R&D Principal Scientist to lead method development and qualification for liquid and gas chromatography, supporting drug products through early to late-stage development on site in Grand Rapids, MI. The role requires extensive HPLC/UPLC and GC experience and a strong track record in pharmaceutical analytical development.

You will oversee investigations, drive corrective actions, and support regulatory filings while serving as the subject matter expert during audits.