Downstream Development Associate II

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 Bio Pharmaceuticals (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 Process Science & Validation Team.

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 to advance brain health and transform lives.

Summary:

Performs downstream process development experiments and supporting activities, which enable both early and late-stage manufacturing process design for therapeutic monoclonal antibody production via yeast and mammalian expression systems.

Essential Functions:

• Performs small-scale downstream process development experiments for monoclonal antibodies, as applied to liquid chromatography and tangential/normal flow filtration.
• Prepares experimental intermediate samples for further analytical testing, including purification via miniature liquid chromatography and ultrafiltration devices.
• Prepares purified protein product to support upstream process development and supply further downstream process development activities.
• Performs analytical methods, such as UV-visible spectrophotometry, turbidimetry, density measurement, size exclusion and protein A affinity HPLC, and biolayer interferometry.
• Organizes and analyzes primary data and prepares concise presentations and reports.

Required Education, Experience, and Skills:

• Accredited bachelor's degree and a minimum of 2+ years of biotechnology/pharmaceutical industry experience or equivalent combination of education and experience totaling 4 years.
• Basic understanding of the principles of liquid chromatography, membrane filtration, sedimentation/centrifugation, aqueous physical chemistry, and protein chemistry.
• Familiar with basic laboratory equipment, including pH, conductivity, & temperature meters, pumps, pressure gauges, weight scales, pipette dispensers, and tabletop centrifuges.
• Excellent verbal communication skills to interact collaboratively with Process Development teammates.
• Well-developed organizational skills and the ability to take a proactive approach to job responsibilities.
• Ability to comply with FDA GMP documentation regulations and industry standard safety practices.
• Proficiency in Microsoft Windows 10/Office.
• Must be able to lift to 30 pounds on occasion.

Preferred Qualifications, Skills and Competencies

• An accredited B.S. degree in science or engineering (i.e. Biochemical Engineering, Chemical Engineering, Biotechnology Engineering, Biochemistry, Biotechnology or equivalent).
• Experience with analytical techniques such as HPLC, UPLC, and/or CE a plus.
• Experience with pilot scale operations a plus.
• Experience with MPLC systems such as the Äkta/Unicorn platform a plus.

The range displayed is specifically for those potential hires who will work or reside in the state of Washington, if selected for this role, and may vary based on various factors such as the candidate's qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $38/hour - $45/hour and eligibility for an 8% bonus target based on company and individual performance.

Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our site.

Why Lundbeck

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.

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