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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 Associate Scientist within the Analytical Science and Technology department 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. Duties & 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. Education & Experience 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. 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. Knowledge, Skills, Abilities Strong written, verbal, presentation, and interpersonal communication skills. Detail oriented with good organization skills. Ability to prioritize, independently manage and complete deliverables within given timelines. Ability to problem solve and apply risk-based critical thinking in a technical environment. Demonstrated history of continuous improvement is desired. Physical Demands The role is a combination of laboratory and office based work. The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals i