Principal Scientist R&D Analytical Methods

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