Senior Scientist, Biologics, Drug Product and Formulation Development

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Job description

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 will interact with internal product development groups and with Lundbeck's external CMOs/contract labs. Primary responsibilities involve leading programs by supporting clinical and commercial manufacturing, designing and overseeing laboratory experiments supporting process development, technology transfer, deviation closure, data analysis and trending utilizing statistics, and authoring complex reports supporting process validation for drug product.

ESSENTIAL FUNCTIONS:

• Lead programs involving a wide variety of process development and manufacturing activities including:
• Author GMP protocols and in-process test plans to meet development and commercialization timelines
• Generate and implement design of 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 complex 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 5 years of biopharma industry experience. Accredited Master's degree with 10 years of biopharma industry experience, Accredited Bachelor's degree with 12 years of biopharma industry experience a or a combination of education and experience or a combination of education and biopharma experience totaling 15+ years
• In-depth 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
• The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Ph.D. in a relevant scientific discipline (such as engineering, physical / analytical chemistry
• Experience with development of combination products (PFS, AI etc.)
• Experience with high concentration pre-filled syringe configurations

TRAVEL

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

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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 .