Scientist, Analytical Sciences

Scientist, Analytical Sciences & Technology 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. Duties & 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. Education & Experience 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. Knowledge, Skills, Abilities 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. 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 including cytotoxic compounds, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required. Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, sitting, kneeling, climbing on stepstools, and reaching may be required. Repetitive use of arms/hands/wrists and grasping may be required. The role may require unassisted lifting (not to exceed 50 lbs.). Position is primarily laboratory and office-based with occasional work in a classified GMP manufacturing environment. Dynamic, fast-paced, interactive, and entrepreneurial environment. Position is a team and project-based position that may require occasional shift work, weekends, and holidays. Supervisory Responsibilities This position does not have direct reports; however, demonstrated leadership experience is preferred to assist in mentoring junior staff. Travel 5% travel is required for this position. Work Location New York Pay Range $76,000 - $113,000 USD We are an Equal Employment Opportunity (“EEO”) Employer. We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today #J-18808-Ljbffr