Position Overview:
As an Analytical Development Scientist, you will play a critical role in supporting the development and transfer of analytical methods for biologic drugs, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs). You will work closely with cross-functional teams to ensure the quality, safety, and efficacy of our therapeutic candidates, contributing to the advancement of our pipeline and ultimately improving patient outcomes. Key Responsibilities: Develop and write standard operating procedures (SOPs), experimental methods, and reports for analytical testing. Perform routine analytical tests using a variety of techniques, such as size exclusion chromatography (SEC), capillary electrophoresis (CE), isoelectric focusing (ICIEF), and Protein A analysis. Support the development and transfer of analytical methods for biologic drugs, collaborating with upstream and downstream process development teams. Understand the Chemistry, Manufacturing, and Controls (CMC) processes for biologic drugs, ensuring alignment with quality control (QC) and quality assurance (QA) specifications. Collaborate with application teams to meet quality requirements for biologic drug applications, conducting experiments and generating reports as needed. Assist with sample preparation, reagent management, and stable sample management to support analytical testing activities. Core Competencies, Knowledge, and Skills: Previous experience in an FDA-regulated biotechnology or pharmaceutical company is required. Proficiency in analytical chemistry or biology, with expertise in analyzing biological drug products using techniques such as high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), CE, and enzyme-linked immunosorbent assay (ELISA). Strong written and verbal communication skills, with the ability to effectively communicate complex scientific concepts to stakeholders at all levels. Excellent analytical and problem-solving abilities, with a demonstrated capacity to prioritize tasks and manage time effectively. Self-motivated and proactive, with a commitment to continuous learning and professional development. Significant Contacts: Interacts with all levels of company employees, including cross-functional teams in research and development, manufacturing, quality control, and regulatory affairs. Join Our Team:
If you are passionate about advancing innovative therapies and making a meaningful impact in the lives of patients, we invite you to join our dynamic team with us. Apply now to contribute your expertise to our mission of developing transformative medicines for patients in need.
