Associate Scientist, AS&T

Lotte Biologics Usa•Syracuse, NY

4d•Hybrid

About The Position

The Associate Scientist within the Analytical Science and Technology is responsible for supporting analytical method lifecycle activities including method development, qualification, validation, and technical transfer of methods for the testing of biologics in-process and drug substance samples. The candidate will execute non-GMP testing, reference standard qualification, and comparability studies to support clinical and/or commercial GMP manufacturing.

Requirements

B.Sc./B.Eng. in Biology, Chemistry, Biotechnology, or equivalent area of related study with 3-5 years, or M.Sc./M.Eng. with 0-2 years, industry experience in biologic/protein analytics.
Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is required.

Nice To Haves

Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.
Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired.
Demonstrated history of continuous improvement is desired.

Responsibilities

Develop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and other associated scientific technical documents.
Perform testing of study samples to support upstream and downstream manufacturing process development, characterization, and process improvements.
Document and evaluate experimental results and perform data verification and trending.
Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues.
Identify new analytical technologies and opportunities for technical advancements.
Support the preparation and review of regulatory submissions related to analytical procedures, method development and validation, specifications, reference standards, extended characterization, and product stability/ shelf-life.
Support regulatory inspections, third-party audits, and customer audits through participating in inspection readiness and addressing inspectional findings.
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.