Senior Manager Analytical Development

Overview Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your work? Lundbeck Seattle Biopharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since joining Lundbeck in 2019, Lu-SBP has supported the commercial launch of Lundbeck’s first biologic product (Vyepti) and the advancement of a growing biologics pipeline in collaboration with the Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Responsibilities Manage and develop a team of scientists, including coaching, mentoring, and performance management Directly contribute to experimental design, data analysis, troubleshooting, and interpretation of mass spectrometry data Provide hands-on technical expertise in LC-MS-based characterization of biologics, including intact mass, peptide mapping, PTMs, sequence variant, HCP, and glycosylation analysis Design, develop, and implement analytical methods for biologics characterization and routine testing Serve as an analytical lead for biologics programs as needed, contributing to analytical strategy within cross-functional CMC teams Contribute to CQA identification, risk assessment, and characterization activities Lead and execute characterization, comparability, and forced degradation studies Author and review methods, protocols, reports, and regulatory documentation Collaborate closely with cross-functional teams to support development activities and timelines Operate effectively within a matrix organization, supporting shared resources Provide administrative matrix management for assigned potency team members, including performance input and formal reviews, in alignment with potency scientific leadership Support transfer of analytical methods to external labs and review data as needed Identify and implement improvements to analytical workflows and technologies as appropriate Required Education, Experience and Skills PhD in Biochemistry, Chemistry, Biological Science, or related field with a minimum of 5+ years relevant experience Experience building high-performing teams Proven ability to manage performance, provide feedback, and drive accountability Experience managing or mentoring scientists while remaining technically hands-on Experience serving as an analytical lead or contributing to CMC teams Working knowledge of Critical Quality Attributes (CQAs) and characterization strategies Deep expertise in mass spectrometry for biologics (intact mass, peptide mapping, PTM analysis) Strong understanding of biologics characterization and analytical method development Experience working in a matrixed organization is preferred Strong communication and collaboration skills Preferred Education, Experience and Skills Knowledge of biologics CMC development from pre-clinical through clinical to commercialization Experience in supporting regulatory submissions Experience using mass spectrometry for identification and quantification of sequence variants (e.g., misincorporation), host cell proteins and N-glycan analysis/mapping Prior Leadership training would be beneficial Travel Willingness/Ability to travel up to 10% domestically and/or internationally. The salary range for this role is $170,000 to $190,000 with eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Additional benefits include flexible paid time off (PTO), health benefits (Medical, Dental, and Vision), and a company match 401k. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to providing reasonable accommodations to disabled veterans and other individuals with disabilities during the employment application process. If you need a reasonable accommodation, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace and participates in E-Verify. #J-18808-Ljbffr