Principal Scientist

Employer
Lundbeck
Location
Bothell, Washington
Posted
Jan 24, 2022
Ref
2700
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Full time

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!

 

POSITION SUMMARY:
Leads effort on early and late stage formulation development of monoclonal antibodies, development stabilities, clinical in-use compatibilities, comparability for process changes. This includes initiate projects, literature review, experimental design, execution, data analysis, and report writing
 
ESSENTIAL FUNCTIONS:

  • Lead effort on high concentration formulation development both in vials and in prefilled syringes for all Lundbeck protein candidates.
  • Participate cross functional project meetings, provide subject matter expert support and accountable for team deliverables.
  • Interact and provide expert support to Lundbeck Seattle and Headquarter (Valby) quality, clinical team, DP manufacturing and engineering groups.
  • Lead product in-use compatibility studies for IV and subcutaneous administration. 
  • Lead forced degradation studies for IND and BLA comparability studies.  Involve in protein particulate and aggregate characterization. 
  • Supervisory responsibility  

 

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

  • Ph.D. degree with 6+ years of experience, or combination of education and experience totaling 10 years
  • Monoclonal antibody formulation development, aseptic operation experience, be familiar with analytical tools for drug product development such as, not limited to, SE-HPLC, UV/vis spectroscopy, viscosity determination and knowledge and experience of compendia assays, especially particulate analysis.
  • Hands on experience with protein sample preparations, aseptic operations, and stability studies are essential
  • Candidate should be able to use in-depth understanding of protein properties in designing experiments and interpreting results. 
  • Successful candidate will have excellent oral, written communication skills and interpersonal skills.
  • Ability to focus and work in a fast-paced and results oriented environment is essential

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Degree in Chemistry, Chemical Engineering, or Biochemistry 

 

TRAVEL:

  • Domestic and international travel up to 10% may be required.

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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.