Senior Manager Analytical Development

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 hard work? Lundbeck Seattle Bio Pharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our 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. Join us on our journey to advance brain health and transform lives.

SUMMARY

Lundbeck Seattle Biopharmaceuticals is seeking a highly motivated and experienced scientific leader to manage the Characterization and Development team within the Analytical Development department. This role includes responsibility for mass spectrometry, characterization, comparability and forced degradation studies of biotherapeutic molecules to support process development and changes to clinical and marketed products.

The characterization team includes analytical leads supporting Lundbeck biologics programs, and this role will also serve as an analytical lead as needed. This role will support development programs through execution of analytical strategies, including Critical Quality Attribute (CQA) identification and assessment.

The successful candidate will have demonstrated leadership in analytical characterization of biologics, including a strong familiarity with the use of mass spectrometry as applied to biologics. Knowledge of protein biochemistry, enzymology, chromatography, N- and O-linked glycosylation, cell biology, biophysical characterization, and proteomics as they pertain to biologics will also be beneficial.

This role operates within a matrixed team structure, contributing to management of the Potency team in Analytical Development.

ESSENTIAL FUNCTIONS

• 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…