Key skills
LeadershipCollaboration
About this role
Role Overview
- Lead and/or perform analytical investigations with a strong focus on quality and regulatory compliance.
- Perform impurity isolation, unknown peak identification, characterization of degradation pathways, and trace impurity quantitation (e.g., carcinogens/mutagens such as nitrosamines).
- Utilize specialized instrumentation such as mass spectrometers and other spectroscopic techniques.
- Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the manufacturing network to identify issues and gaps, implement solutions to troubleshoot and optimize lab test methods, workflows, and materials, ensure compliant, robust, and responsive supply chain.
- Demonstrate the ability to influence meaningful outcomes through leadership and collaboration.
Requirements
- Bachelor of Science (BS) degree in chemistry or related sciences with at least ten (10) years of combination experience in analytical chemistry and instrumentation OR
- Master of Science (MS) degree in chemistry or related sciences with at least eight (8) years of combination experience in analytical chemistry and instrumentation OR
- Ph.D. degree in chemistry or related sciences with at least four (4) years of combination experience in analytical chemistry and instrumentation
- Working knowledge of developing various analytical techniques (e.g., chromatography, mass spectrometry, spectroscopy)
- Author analytical procedures, method development, validation and transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc.
- Working knowledge of trace impurity quantitation, impurity isolation, and structure characterization.
- Experience working with CMOs and CROs.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days