Lott Oil Company ยท 21 hours ago
Sr. Scientist, Analytical Sciences & Technology
Syracuse, NY
Full-time
Onsite
Mid, Senior Level
$85K/yr - $118K/yr
3+ years expLOTTE BIOLOGICS is a new company committed to delivering therapies that enable a healthier world. The Senior Scientist will lead analytical method development for biologics and other protein modalities, overseeing testing and implementation of analytical methods to support client projects from pre-clinical to commercial stages.
EnergyFuelNatural Resources
Responsibilities
Lead analytical method development and demonstrate expertise with protein biotherapeutic test methods used to characterize products
Leverage a strong understanding of the drug substance process to lead testing of upstream and downstream process development samples
Document results and perform data analysis, interpretation, and trending
Design, author, and review standard operating procedures, methods, protocols, reports, change controls, and regulatory submission supporting documentation
Lead technical transfers to quality control and serve as an analytical expert for transfer and validation activities, investigations, method troubleshooting
Actively mentor less experienced scientists to facilitate their development
Identify opportunities for technical advancements and implement new analytical technologies
Lead analytical client interactions, support site inspections, review regulatory filings and prepare CMC inquiry responses as required
Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities
Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results
Qualification
Required
B.S. in Biology, Chemistry, or equivalent area of related study with 7-9 years, M.S. with 3-6 years, or Ph.D. with 1-3 years, of industry experience in biologic/protein analytics
Experience in protein biotherapeutics for a variety of instrumentation (i.e., HPLC/UPLC, qPCR, ELISA, CE-SDS, iCIEF, UV-VIS, MS, GC, and cell-based assays) is required
Experience with the biopharmaceutical development process, ICH guidelines, compendial requirements, and experimental statistical design/data analysis is required
Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is required
Preferred
Experience developing bridging studies between new and existing methods, method comparability studies, and product comparability studies required to support CMC changes is preferred
Experience leading analytical method change controls within a Quality Management System and ensuring all required test data and reports are available to support and justify the change(s) is preferred
Experience defining analytical control strategy, coordinating the specifications development process, preparing the specification package documents, and driving the process for internal and regulatory approval of the specifications is desired
Benefits
Target Bonus 10%
Company
Lott Oil Company
Lott Oil is a regional leader in fuels, lubricants, and related products and services for industrial, commercial fleet, automotive, and retail customers throughout Louisiana and East Texas.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase