Senior Scientist, Formulations

Employer
Lundbeck
Location
Bothell, WA, United States
Posted
Nov 19, 2020
Ref
1414
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 Late-Stage Development and Production groups. 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.

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of 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.

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.

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Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.