Senior Scientist Downstream Development

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 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 of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!

SUMMARY:

Lundbeck Seattle BioPharmaceuticals is seeking a Senior Scientist to join the Downstream Development team.

In this role you will have the opportunity to make significant contributions to the downstream process development of biologics within the CMC Process Development team. You will work closely with scientists in teams from Upstream, Formulations and Analytical development as well as members of the Lundbeck Quality organization to advance therapeutic biologic compounds through clinical to late-stage development.  The successful candidate will act in technical capacity as Subject Matter Expert (SME) with the deep understanding of connection of operations from harvest, capture, viral reduction, and polish chromatography to formulation. Strong bench, analytical and oral/written communication skills are expected.

ESSENTIAL FUNCTIONS:

• Scale-up/down of chromatography, harvest and UFDF operations
• Develop innovative, efficient and robust downstream processes for variety of biologic proteins at different stages of development
• Design and execute purification screening, scouting and characterization experiments
• Purify biologic protein lots from bench to pilot-scale to support analytical, formulation and pre-clinical studies
• Present data and actively participate in discussions on experimental design, analysis, and conclusions
• Author and review development reports, process descriptions and performance records to support projects from early to later stages of development
• Strive to keep Lundbeck Seattle’s Center of Excellence at cutting edge of innovation and technology advancement
• Support Technical Transfer activities to and from CMOs and use process and product knowledge to troubleshoot processes at manufacturing sites
• Represent downstream function in international cross-functional project teams, external Core Team meetings with CMOs, and effectively communicate with senior management
• Support regulatory colleagues in contributing (authorship and review) to CMC sections (IND, BLA) for global filings

Required Education, Experience and Skills:

• Ph.D. with 5+ years’ relevant experience in biopharmaceutical industry, or M.S. with 10+ years’ relevant experience in biopharmaceutical industry, or B.S. with 12 + years’ relevant experience in biopharmaceutical industry or 15+ years relevant combination of education and experience
• Strong chromatography resin and membrane chemistry knowledge

• Skilled in Unicorn-based AKTA programming and result evaluation
• Experienced with UFDF and filter sizing studies
• Expertise with viral clearance (requirements, study design, execution and evaluation) for early-stage (IND-enabling) programs
• Experienced in downstream process characterization and PPQ readiness activities
• Strong technical skills including demonstrated experience developing and transferring successful downstream processes
• Demonstrated ability to manage effectively and independently laboratory work and operational and performance data. in appropriate databases for trending purposes.
• Demonstrated ability to collaborate in focused downstream team and multi-disciplinary matrixed team environments. Excellent interpersonal skills.

Preferred Education, Experience and Skills:

• Mastery of JMP statistical software (DOE setup and analysis, data cleanup, modeling, trending, graphing)
• Familiarity with biologics purification scale-up/scale down and manufacturing considerations
• Pilot scale or larger manufacturing experience of biologics
• Strong familiarity with Good Manufacturing Practices (GMP)
• Experience with electronic lab notebooks, and database interfaces for data entry, management of experimental accuracy, and use in data trending activities
• Experience with developing and supporting manufacturing-scale Harvest activities (including both centrifugation and depth filtration)
• Expertise with viral clearance) for late-stage (BLA-enabling) programs
• Strong scientific writing skills
• Experience in supporting regulatory submissions including authoring, reviewing, and responding to regulatory questions

TRAVEL

• Domestic and international travel up to 10% may be required

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: $145,000 - $165,000 and eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. 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.    #LI-LM1

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.
 

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.