Agilent Technologies is looking for a Scientist in the Analytical Services team to execute analytical techniques for method acquisition, qualification, transfer, and validation to support Active Pharmaceutical Ingredient (API) manufacturing.
Requirements
- 4+ years of demonstrated expertise in method validation, proficiency in analytical platforms such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, and Karl Fischer.
- Demonstrated experience with performing and guiding analytical method acquisition, qualification, transfer and validation for the analysis of raw materials, chemical intermediates and final products that supports API manufacturing.
- Demonstrated experience with adhering to regulatory compliance for analytical method validation pertaining to the manufacture of API’s.
- Ability to skillfully operate multiple instrument technologies (e.g. UPLC, GC, GC/MS, HPLC/MS, FTIR, UV/VIS, IC, ICP/MS, flame AA).
- Demonstrated experience of analytical test methods used in the testing of oligonucleotide API or related molecules is highly desired.
- Ability to work independently and with interdisciplinary project teams, understand project requirements, and follow project timelines.
Responsibilities
- Independently initiate, design and execute laboratory scale experiments using analytical instrument platforms such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, Karl Fischer.
- Author and review method validation protocols and reports with adherence to ICH guidelines and internal Agilent standard operating procedures (SOPs).
- Properly record and summarize experiments in notebooks and reports and present research summaries to internal and external customers.
- Maintain process compliance integrity by adhering to SOPs and current good manufacturing practices (cGMP) as appropriate.
- Operate laboratory equipment by following operating instructions, troubleshooting instrumentation and method issues, and performing routine preventative maintenance.
- Interfaces with various departments and serves as internal consultant for analytical services.
- Provide mentorship and technical guidance to research associates, serve as a resource for team development
Other
- Train team members to cover all aspects of analytical services job functions according to job level.
- Guide work activities of analytical research associates
- Bachelor's degree (B. S.) or Master’s degree (M.S) in chemistry, or related applied sciences field.
- 8+ years relevant experience and/or training; or equivalent combination of education and experience.
- Occasional travel required.
