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LOTTE Biologics · 3 hours ago

Sr. Scientist, Analytical Sciences & Technology

Syracuse, NY

Full-time

Onsite

Mid, Senior Level

$85K/yr - $118K/yr

3+ years exp

LOTTE Biologics is a new company committed to delivering therapies for a healthier world. The Senior Scientist will lead analytical method development for biologics and other protein modalities, ensuring high-quality testing and compliance throughout pre-clinical to commercial stages.

AnalyticsBiotechnologyManufacturing

H1B Sponsor Likely

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

Qualification

Analytical method developmentProtein biotherapeuticsHPLC/UPLCBiopharmaceutical developmentStatistical designRegulatory submissionQuality Management SystemInterpersonal communicationMentoringProject management

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

Ability to interpret technical data and results to draw appropriate conclusions, apply risk-based quality principles, and identify logical next steps to ensure good scientific, compliance and regulatory outcomes

Strong verbal, written, presentation, and interpersonal communication skills with ability to clearly articulate scientific objectives and results to lead discussions, build alignment, and make recommendations

Ability to prioritize, manage team priorities/resources, and complete project deliverables within given timelines

Organized, detail oriented, and proficient in writing formal reports, documents, and technical presentations

Aptitude as a functional mentor/technical point of contact and ability to effectively train others

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

Demonstrated leadership experience is preferred

Benefits

Target Bonus 10%

Company

LOTTE Biologics

LOTTE Biologics offers end-to-end CDMO services for biopharmaceutical manufacturing, aiming for global top 10 status.

Founded in 2022

Seoul, Seoul-t'ukpyolsi, KOR

501-1000 employees

https://lottebiologics.com

H1B Sponsorship

LOTTE Biologics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2023 (1)