Scientist, Analytical Sciences & Technology

Lotte Biologics Usa • Syracuse, NY

11d • $76,000 - $113,000 • Onsite

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 Scientist, Analytical Sciences & Technology is responsible for the testing of biologics, ADCs, and other modalities in-process, drug substance, and drug product samples. The candidate will implement analytical methods for a variety of techniques to support early-stage product development through commercialization.

Requirements

• BS in Biology, Chemistry, Biotechnology, or equivalent area of related study with 5-7 years, MS with 2-4 years, or PhD with 0-2 years, of industry experience in biologic/protein analytics.
• Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation (i.e., HPLC/UPLC, qPCR, ELISA, CE-SDS, iCIEF, UV-VIS, MS, GC, and cell-based bioassays) is required.
• Working knowledge and experience in the biopharmaceutical development process, regulatory guidance, 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.

Nice To Haves

• This position does not have direct reports; however, demonstrated leadership experience is preferred to assist in mentoring junior staff.

Responsibilities

• Perform analytical method development, qualification, validation, and method transfer activities, developing subject matter expertise with protein biotherapeutic test methods used for structural elucidation and physicochemical characterization of biologics and other modality products.
• Lead analytical activities and testing of upstream and downstream study samples.
• Design, author, and review standard operating procedures, methods, protocols, reports, change controls, regulatory submission supporting documentation.
• Optimize and lead technical transfers.
• Perform routine laboratory activities including sample management, instrument maintenance/calibration, inventory/ordering of supplies, general housekeeping.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level