Sr. Scientist, Analytical Sciences & Technology
About The Position
We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World . A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science , Embracing Diversity , Fostering Talent , and Connecting Lives . Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary The Senior Scientist is responsible for analytical method development for the testing of biologics, ADC's, and other protein modalities. You will lead the implementation of analytical methods for a variety of instruments and techniques to support pre-clinical to commercial stage client projects. You will perform non-GMP testing, pre-clinical stability studies, reference standard qualification, and comparability studies.
Requirements
- 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.
Nice To Haves
- 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.
- Demonstrated leadership experience is preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
