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Scientist II

 
Requisition ID:  1627
Location: 

Bothell, Washington, US

Date:  Feb 9, 2021
 

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 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. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!
 

SUMMARY:
Ensure drug product processes are robust, scalable, well-characterized, and economical for pipeline molecules. The role is primarily lab-based and will interact with internal product development groups and may interact with Lundbeck’s external CMOs/contract labs. Primary responsibilities include supporting clinical and commercial manufacturing, designing, overseeing and conducting laboratory experiments supporting process development, technology transfer, deviation closure, data analysis and trending utilizing statistics, and authoring reports supporting process validation for drug product.

 

ESSENTIAL FUNCTIONS:

  • Participate in a wide variety of process development and manufacturing activities including:
  • Author and review GMP protocols and in-process test plans to meet development and commercialization timelines
  • Design and conduct experiments with subsequent statistical analysis of data
  • Author regulatory sections for regulatory filings
  • Perform on-site troubleshooting during process scale-up (international travel required)
  • Interpret analytical results, present findings, and write technical reports used as primary references for regulatory filings
  • Represent process development and manufacturing on one or more internal project teams and also on CMO/external project teams to ensure successful process transfer

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Ph.D. with 2 years of biopharma industry experience, Accredited Master’s degree with 5 years of biopharma industry experience, Accredited Bachelor’s degree with 7 years of biopharma industry experience a or a combination of education and biopharma industry experience totaling 12+ years
  • Some understanding of unit operations used for formulation and aseptic fill-finish/drug product manufacturing of liquid formulations of monoclonal antibodies. 
  • Demonstrated experience including developing acceptance criteria for technology transfer and validation

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Ph.D. in a relevant scientific discipline (such as engineering, physical / analytical chemistry)
  • Some experience with development of combination products (PFS, AI etc.)

 

TRAVEL

  • Willingness/Ability to travel up to 10% domestically and internationally


 

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.


 

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.