Senior Manager Analytical Development

Lundbeck

Bothell, WA

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JOB DETAILS

SKILLS

Administrative Management, Analysis Skills, Analytical Development, Analytical Method Development, Biochemistry, Biology, Cell Biology, Chemistry, Chromatography, Coaching, Communication Skills, Cross-Functional, Data Analysis, Documentation, Drug Manufacturing, Drug Products, Experiment Design, Identify Issues, Incentive Programs, Laboratory Analysis, Leadership, Liquid Chromatography-Mass Spectrometry (LC-MS), Manufacturing/Industrial Processes, Mass Spectrometry, Matrix Management, Medical Products, Mentoring, Neurology, Performance Management, Pre-Clinical, Pre-Clinical Development, Process Development, Process Validation, Product Development, Product Marketing, Proteomics, Psychiatry and Mental Health, Regulatory Reports, Regulatory Submissions, Risk Analysis, Sales Pipeline, Team Player, Willing to Travel, Workflow Analysis, Writing Skills

LOCATION

Bothell, WA

POSTED

30+ days ago

Senior Manager Analytical Development Requisition ID: 7619 Location: Bothell, WA, US 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 BioPharmaceuticals (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 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 range displayed is specifically for those potential hires who will work or reside in the state of Washington, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $170,000 - $190,000 and 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 for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our site (https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck\_Benefits\_Summary.pdf) . Applications accepted on an ongoing basis.\#LI-LM1 **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 theU.S. career site (https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck\_Benefits\_Summary.pdf) . _Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S. career site (https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy) ._ _Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates inE-Verify (https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify\_Participation\_Poster\_Eng\_Es.pdf) ._ **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real. **About Lundbeck** At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real.

About the Company

Lundbeck

INDUSTRY

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