Senior Scientist

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with sites worldwide including in Bothell, Washington, Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

In October 2019, Lundbeck acquired Alder Biopharmaceuticals, now known as Lundbeck Seattle BioPharmaceuticals (Lu-SBP).  The Lu-SBP site is responsible for antibody development and biologics manufacturing in collaboration with the global Lundbeck CMC Biologics organization.

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 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

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.