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 Scientist I to join the Characterization & Development group as part of our Analytical Development team. The successful candidate will be working in a state-of-the-art mass spectrometry lab, and developing liquid chromatograph, mass spectrometry, and other analytical methods for therapeutic protein product analysis. The individual will have a background in protein sciences and analytical techniques and a strong ability to work cross-functionally in a fast-paced environment. This lab-based role will provide an exciting opportunity to gain hands-on experience in analytical development to support drug development from early to late-stage clinical programs.

ESSENTIAL FUNCTIONS:

• Assist with all aspects of analytical development, including new assay development, qualification and validation, and routine sample analysis
• Conduct routine LC-MS sample analysis to support characterization, stability, formulation development, and comparability studies by following experimental design, protocols, and SOPs
• Contribute to the development of new analytical methods, such as H/UPLC and LC-MS-based assays, to augment our analytical capabilities for release, characterization, and stability testing
• Document experiments, results, and findings in electronic laboratory notebook; present work at group and department meetings; draft SOPs, development reports, and regulatory submission documents
• Provide cross-functional support to upstream/downstream process development, formulation, and quality control teams
• Collaborate with QC to support method transfer and validation at contract labs/CMOs
• Contribute to analytical sections for regulatory submissions while ensuring high-quality data integrity and documentation
• Collaborate with multi-disciplinary teams, effectively communicate results in oral and written formats
• Demonstrate a willingness to quickly learn new skills and technologies and adapt to changes
• Participates in general lab and instrument maintenance

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

• Ph.D. in a relevant scientific discipline such as Analytical Chemistry or Biochemistry with 0-2 years related experience in a mass spectrometry-oriented lab and with a proven track record of publications in the field, or an accredited masters of sciencewith a minimum of 6 years of similar relevant experience
• Hands-on experience with mass spectrometry, familiarity with mass spec principles and application to protein characterization with keen analytical and problem-solving skills
• Strong collaboration skills and experience working with cross-functional teams
• Strong scientific computing skills, experience using MS Office suite for scientific purposes
• Excellent oral and written communication skills
• Excellent organizational, critical thinking, and troubleshooting abilities
• Ability to adapt quickly in a dynamic, fast-paced environment with changing priorities
• Highly self-motivated, organized, and detail-oriented, with a can-do attitude

PREFERRED EDUCATION, EXPERIENCE, AND SKILLS

• Ph.D. with 0-2 years related experience
• Experience with TOF, Orbitrap, Agilent and Waters H/UPLC instruments
• Familiarity with analytical methods including HPLC (RP-, SEC-, IEX-, HIC-, HILIC-), cIEF, CE-SDS and peptide mapping
• Experience in host cell protein analysis and sequence variant analysis
• Proficiency in mass spectrometry related software, such as Xcalibur, MassHunter, BioPharmaFinder, Qualitative Analysis, Proteome Discoverer, Empower, etc. Abilities in computer programming is a plus
• Knowledge of antibody structure and function and experience analyzing macromolecules (proteins, antibodies, etc.)
• Familiarity with regulatory requirements for analytical testing and prior experience drafting and supporting regulatory submissions
• Knowledge of biologics CMC development from pre-clinical through clinical to commercialization
• Knowledge of Critical Quality Attributes (CQAs) for biologics
• Experience with electronic lab notebooks (e.g., Benchling)

TRAVEL:

Willingness to travel up to 5% 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: $125,000 - $145,000 and eligibility for a10% bonus target based on company and individual performance. 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 career site. 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 the U.S. career site.

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 the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. 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 in E-Verify.