Principal Scientist R&D Analytical Methods

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

We are seeking an R&D Principal Scientist who will lead a highly motivated team through method development, qualification and optimization supporting existing and future drug products. This position requires method development and qualification experience for both liquid and gas chromatography (HPLC and GC) and will be responsible for leading laboratory investigations, implementing corrective actions, supporting regulatory filings and serving as the subject matter expert for method qualification during regulatory audits.

Responsibilities:

• Plans, designs, and oversees analytical method life-cycle activities through multiple stages of development.
• Accountable for technical oversight and phase-appropriate development, qualification/ validation, re-assessment, and transfer of chromatographic and physical methods targeted for raw material, in-process, release, and stability testing of early and late-stage development programs.
• Contributes expertise on data interpretation, instrumentation, and trouble shooting.
• Tracks analytical method performance and implements analytical method remediation measures, when required, from early data signals.
• Support laboratory-related root cause analysis and unexpected results (OOS/OOT) investigations.
• Contributes expertise to stability study and comparability study design.
• Support of CMC regulatory filings.

Qualifications:

• Bachelor’s degree in chemistry, biochemistry, or related field and a minimum of 15 years of related, progressively responsible experience in analytical development in the pharmaceutical industry. Master’s degree with 12 years of experience or a PhD with 8 years preferred.
• Knowledge of USP, ICH and FDA requirements.
• Extensive experience with HPLC/UPLC, GC, wet chemistry techniques and USP methods.
• Analytical method validation/development experience in the pharmaceutical industry.
• Experience conducting technical investigations into out of specification, aberrant, or unexpected results.
• Experience in Dissolution, IVRT/IVPT method development and validation.
• Experience in transdermal products preferred.

This full time role is onsite in Grand Rapids, Michigan and relocation assistance is provided.

Job Identifier: #10324