Principal Scientist Characterization and Development

Employer
Lundbeck
Location
Bothell, Washington
Posted
Jan 12, 2022
Ref
2647
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Contract

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 is a wide-ranging role with responsibility for leading characterization, comparability and forced degradation studies of biotherapeutic molecules to support process development and changes to marketed products.
This role will lead all mass spectrometry at Lundbeck Seattle including technology development to establish new methods and streamline existing workflows for sample preparation, data analysis and reporting.
The successful candidate must have a strong background and demonstrated leadership in analytical characterization of biologics, including intimate familiarity with the operation of mass spectrometers (TOF and Orbitrap instruments) and mass spectrometry software (open-source and commercial options) for deconvolution of intact mass spectra and analysis of peptide mapping data.
Strong 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 be critical for success in this role. Familiarity with protein biophysics and factors that impact the stability of biologics will be beneficial.

 

ESSENTIAL FUNCTIONS

  • Lead the characterization team with responsibility for several direct reports and all mass spectrometry work in support of routine analysis and characterization of biologics
  • Provide scientific leadership and technical expertise for biotherapeutic characterization
  • Develop and implement methods for mass spectrometry-based experiments including methods for characterization of sequence variants and host cell proteins
  • Develop and implement analytical methods (e.g., cIEF, RP, HIC, IEX, HILIC) for characterization and routine testing of biologics
  • Ensure proper operation of mass spectrometers (TOF and Orbitrap) and associated chromatography instruments
  • Lead, plan and execute characterization, comparability and forced degradation studies including writing of protocols and detailed reports
  • Develop and implement methods intended for release and stability testing
  • Lead peak characterization efforts (e.g., fractionation to support elucidation of structure, comparability, reference standard characterization, impurity characterization)
  • Lead Critical Quality Attribute (CQA) assessments for biologics and author CQA reports
  • Assess biotherapeutic molecular attributes using amino acid sequences and prior knowledge to identify potential quality attributes that may impact primary structure, higher order structure, product related substances and impurities, Fc domain binding properties and potency
  • Assist with troubleshooting and transfer of analytical methods at contract testing labs
  • Author and review methods, SOPs, development reports, and technical reports
  • 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
  • Serve as a Subject Matter Expert for all analytical techniques listed above

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Ph.D. in Biochemistry, Chemistry, Biological Science, or related field with a minimum of 8+ years relevant experience or BS/MS degree with a minimum of 12+ years of relevant experience 
  • 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 with a proven record of career advancement 
  • Excellent communication skills (written and verbal), technical and organizational skills  
  • Strong interpersonal skills and the ability to work in a multi-disciplinary team environment
  • An understanding of the relationship between cell biology and potential protein modifications
  • Must possess extensive hands-on experience with TOF and Orbitrap instruments including:
    • De-novo creation of instrument and data processing methods with a deep understanding of the various settings
    • Use of mass spectrometry for identification and quantification of chemical and post-translational modifications as well as intact mass analysis
    • Dismantling of mass spectrometer sources and front-end hardware, including the S-lens, for cleaning and maintenance
  • Thorough knowledge of mass spectrometry data analysis software (MassHunter, Xcalibur and BioPharma Finder experience will be beneficial)
  • 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
    • Process development as it pertains to antibody manufacturing, including cell line, upstream and downstream development
  • A desire to actively collaborate with other departments (upstream, downstream, cell-line development and quality)
  • 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: 

  • Knowledge of biologics CMC development from pre-clinical through clinical to commercialization 
  • Experience with Critical Quality Attribute (CQA) assessments for biologics
  • Experience in supporting regulatory submissions including authoring/review and responding to regulatory questions
  • 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
  • Familiarity with biophysical characterization of protein therapeutics and factors that impact protein stability
  • Familiarity with the multi-attribute method (MAM) different approaches for deconvolution of intact mass spectra, and proteomics-style data analysis using label-free quantification approaches (e.g., Protein Discoverer, TPP)

 

TRAVEL:

  • Willingness/Ability to travel up to 10% domestically and/or internationally.

#LI-LM1, #LI-Hybrid

 

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.