Associate Principal Scientist, Chemistry
Merck
9 hours ago
Remote friendly (West Point, PA)
United States
Clinical Research and Development
Responsibilities:
- Lead and/or perform analytical investigations focused on quality and regulatory compliance.
- Perform impurity isolation, unknown peak identification, degradation pathway characterization, and trace impurity quantitation (e.g., nitrosamines).
- Use specialized instrumentation (mass spectrometers and other spectroscopic techniques).
- Collaborate with internal sites and CMOs to identify issues/gaps, troubleshoot and optimize lab test methods/workflows/materials, and ensure a compliant, robust, responsive supply chain.
- Maintain knowledge of API/drug product development needs, GMP compliance, and data integrity principles; apply cGMP and data integrity.
Minimum Education/Experience:
- BS in chemistry or related sciences + 10 years analytical chemistry/instrumentation experience and leading/performing analytical investigations in a regulated environment; OR
- MS + 8 years; OR
- PhD + 4 years.
Required Skills/Experience:
- Developing analytical techniques (chromatography, MS, spectroscopy).
- Author procedures, method development/validation/transfer protocols, reports, experimental designs, and regulatory submission documents.
- Troubleshooting; develop/implement CAPAs.
- Trace impurity quantitation, impurity isolation, and structure characterization.
- Strong communication and interdisciplinary teamwork; influence direction in complex/ambiguous situations; adapt to change and manage risk.
- Strategic thinking; self-motivated ownership; experience with CMOs and CROs.
Preferred:
- Pharma drug substance/drug product development/commercialization; CMC filing requirements/ICH guidance; GMP and data integrity knowledge and industry trends.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Lead and/or perform analytical investigations focused on quality and regulatory compliance.
- Perform impurity isolation, unknown peak identification, degradation pathway characterization, and trace impurity quantitation (e.g., nitrosamines).
- Use specialized instrumentation (mass spectrometers and other spectroscopic techniques).
- Collaborate with internal sites and CMOs to identify issues/gaps, troubleshoot and optimize lab test methods/workflows/materials, and ensure a compliant, robust, responsive supply chain.
- Maintain knowledge of API/drug product development needs, GMP compliance, and data integrity principles; apply cGMP and data integrity.
Minimum Education/Experience:
- BS in chemistry or related sciences + 10 years analytical chemistry/instrumentation experience and leading/performing analytical investigations in a regulated environment; OR
- MS + 8 years; OR
- PhD + 4 years.
Required Skills/Experience:
- Developing analytical techniques (chromatography, MS, spectroscopy).
- Author procedures, method development/validation/transfer protocols, reports, experimental designs, and regulatory submission documents.
- Troubleshooting; develop/implement CAPAs.
- Trace impurity quantitation, impurity isolation, and structure characterization.
- Strong communication and interdisciplinary teamwork; influence direction in complex/ambiguous situations; adapt to change and manage risk.
- Strategic thinking; self-motivated ownership; experience with CMOs and CROs.
Preferred:
- Pharma drug substance/drug product development/commercialization; CMC filing requirements/ICH guidance; GMP and data integrity knowledge and industry trends.
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).