Senior Scientist, Characterization and Development

Company: Lundbeck
Location: Redmond
Posted on: August 7, 2022

Job Description:

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 of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!

SUMMARY

Lundbeck Seattle Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Characterization team within the Analytical Development department to support the development of novel therapeutic antibody programs. 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 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, chromatography, N- and O-linked glycosylation, cell biology, UV/Vis and CD spectroscopy and proteomics as they pertain to biologics will also be beneficial.

ESSENTIAL FUNCTIONS

• Lead the characterization and mass spec team with responsibility for several direct reports
• Provide scientific leadership and technical expertise for biotherapeutic characterization
• Develop and implement methods for mass spectrometry-based experiments
• Develop and implement analytical methods for characterization and routine testing of biologics
• Author and/or review methods, SOPs and development reports
• Lead comparability and forced degradation studies, write protocols and reports
• Lead peak characterization efforts to support elucidation of structure, comparability, reference standard characterization, impurity characterization
• Lead Critical Quality Attribute (CQA) assessments for biologics and author CQA reports
• Assist with troubleshooting and transfer of analytical methods at contract testing labs
• Participate in cross-functional project teams as needed to support development
• Identify and implement new technologies and innovative approaches to biotherapeutic characterization, including mass spectrometry
• Assist in the preparation of CMC regulatory submissions including authoring and/or review; participate in CMC regulatory meetings as needed
  
  REQUIRED EDUCATION, EXPERIENCE and SKILLS:
  
  • Accredited Ph.D. with 5 years of relevant experience, accredited Master's degree with 10 years of relevant experience, accredited Bachelor's degree with 12 years of relevant experience a or a combination of education and experience or a combination of education and experience totaling 15+ years
  • Academic background in Biochemistry, Analytical Chemistry, or related discipline (e.g. Chemistry, structural biology) with demonstrated analytical capabilities.
  • Experience managing two or more direct reports
  • Excellent communication, technical and organizational skills
  • Strong interpersonal skills and the ability to actively collaborate with other departments (Upstream & Downstream PD, Cell Line Development and Quality)
  • Hands-on experience with TOF and Orbitrap instruments
  • Experience developing analytical methods (e.g., cIEF, SEC, RP-HPLC, HIC, IEX, HILIC, N-glycan)
  • Familiarity with:
    • Analytical method development activities and regulatory expectations
    • Regulatory requirements for phase-appropriate biologics characterization and comparability
    • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation
      
      PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
      
      • Ph.D. in Biochemistry, Chemistry, Biological Science, or related field with a minimum of 5+ years relevant experience or BS/MS degree with a minimum of 12+ years of relevant experience
      • Knowledge of biologics CMC development from pre-clinical through clinical to commercialization
      • Knowledge of Critical Quality Attributes (CQAs) for biologics
      • Experience in supporting regulatory submissions
      • Experience with reversed phase separations for characterizing proteins with intact mass methods
      • Experience using mass spectrometry for identification and quantification of sequence variants (e.g., misincorporation), host cell proteins and N-glycan analysis/mapping
        
        TRAVEL:
        
        • Willingness/Ability to travel up to 10% domestically and/or internationally.
          
          Why Lundbeck
          
          Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?
          
          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 .

Keywords: Lundbeck, Redmond , Senior Scientist, Characterization and Development, Other , Redmond, Washington