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.
- 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