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.
Location: Bothell, Washington, US

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 5+ years of experience in monoclonal antibody or other protein formulation development OR an accredited Master's degree with 10 years of experience in monoclonal antibody or other protein formulation development
  • 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, including micro flow imaging.
  • 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

  • Accredited degree in Chemistry, Chemical Engineering, or Biochemistry

For more information and application see the Lundbeck website.