Scientist I - Downstream Process 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!

POSITION SUMMARY

The Scientist I is a part of the Downstream Process Development team. This collaborative team develops processes for therapeutic biologic candidates in preclinical and clinical development. The primary responsibility will be to develop scalable and robust purification processes that produce protein within targeted product quality profile for clinical and commercial scales. This individual plays a synergistic role within downstream group and will collaborate extensively with members of upstream, analytical and formulation development groups.

ESSENTIAL FUNCTIONS:

• Collaborates in process design/development of biologics at multiple all developmental stages
• Incorporates/develops new technology/techniques to improve process efficiency
• Performs downstream process transfer internally and externally
• Designs and executes purification screening, scouting and characterization experiments
• Prepares antibody lots supplies of candidate molecules to support analytical, formulation and pre-clinical studies
• Participates in working as an SME on Task Force groups including those with contract manufacturing organizations
• Presents data and actively participates in discussions on experimental design, analysis and conclusions
• Authors and reviews development reports to support projects from early to later stages of development
• Supports regulatory colleagues in contributing to CMC sections (IND, BLA) for global filings
• Uses process and product knowledge to troubleshoot processes transferred externally to manufacturing sites

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

• PhD with 0+ years' experience in the biopharmaceutical industry or Master's degree with 6 years' experience in the biopharmaceutical industry or an accredited Bachelor's degree with 8 years' experience in the biopharmaceutical industry or relevant combination of education and experience.
• Extensive experience purifying proteins using column chromatography
• Skilled in Unicorn-based AKTA programming and result evaluation.
• 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:

• Accredited Bachelor's of science degree or advanced degree in biochemistry, chemistry or related discipline
• Strong resin chemistry knowledge
• Familiarity with antibody purification scale-up/scale down and manufacturing considerations
• Experienced with GMP practices
• Strong scientific writing skills.
• Knowledgeable in filtration operations: Normal Flow Filtration and Tangential Flow Filtration
• Experienced with UFDF and filter sizing studies
• Labkey familiarity
• Working knowledge of JMP statistical analysis software
• Familiarity with viral clearance for early and late stage programs

TRAVEL

• Domestic and international travel up to 20% may be required.

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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 .