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 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.

POSITION SUMMARY

Lundbeck Seattle’s Center of Excellence located in Bothell, Washington is seeking a highly motivated and experienced Senior Scientist to join the Upstream Process Development team.

The successful candidate will have thorough knowledge and industrial experience related to commercial CHO cell line and cell culture development. Candidate must demonstrate in-depth understanding of cellular and molecular biology with hands-on expertise in molecular techniques, mammalian cell culture, and next generation sequencing to shepherd biologic programs from research through late-stage development, ultimately providing solutions to improve our patient’s brain health. The ability to maintain operational excellence, meet project timelines, and influence stake holders across the organization are key aspects of this role. The candidate will act as Subject Matter Expert (SME) in a technical capacity, manage outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize Lundbeck’s platform process and function as Upstream representative in project teams.

ESSENTIAL FUNCTIONS:

• Manage outsourced cell line development activities, including clonal cell line generation, MCB and WCB generation.
• Perform CHO cell line development processes including, transfection, cloning, characterization, and production in shake flasks and bioreactors as needed to meet project needs.
• Operate state-of-the-art instruments including: ViCell Blu automated cell counter, BioHT analyzer, , Solentim Cell Metric and VIPS single cell seeder, liquid handlers, and REBEL amino acid analyzer. Share responsibility for equipment maintenance and upkeep.
• Review DNA sequencing data (including NGS), Southern/Northern blots, quantitative PCR results.
• Author and review cell line development technical reports that meet expectations of regulatory agencies for all stages from IND to BLA.
• Present updates at cross-functional meetings and collaborate closely with Downstream Development, Analytical and Formulation Development colleagues to meet project timelines.
• Actively seek opportunities to optimize or enhance the cell line development workflow.
• May publish or present scientific findings in peer-reviewed journals, internal or external conferences or consortia.
• Display effective organization, verbal and written communication skills, and adherence to good documentation practices.
• Represent Upstream in Task force meetings, external Core Team meetings with CMOs, making decisions for cell line activities and effectively communicate results, progress and plans through Line of Business and across the CMC organization.
• Strive to keep Lundbeck Seattle’s Center of Excellence at cutting edge of innovation and technology advancement.
• Support GMP characterization of MCB, WCB and LIVCA end of production cell banks.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Ph.D. with 5+ years’ relevant experience in biopharmaceutical industry, or M.S. with 12+ years’ relevant experience in biopharmaceutical industry or B.S. with 15+ years’ relevant experience in biopharmaceutical industry or relevant combination of education and experience.
• Strong technical skills including demonstrated experience creating clonal cell lines for clinical or commercial production of biologic therapeutics.
• Demonstrated ability to effectively and independently manage laboratory work and data, including capturing data accurately in appropriate electronic databases.
• Critical thinking, troubleshooting, and attention to detail.
• Excellent interpersonal skills and ability to work in a multi-disciplinary matrixed team environment.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Advanced degree in molecular biology, biology, biochemistry, chemical engineering, biological engineering, chemistry, or related discipline.
• Experience in CHO cell line development for GMP applications within the biotech or pharmaceutical industry.
• Working knowledge of JMP statistical analysis software.
• Experience in bioinformatics software to analyze DNA and RNA for sequence confirmation and expression analysis.
• Experience using electronic notebooks (Benchling) or similar database for data entry, management of experimental accuracy, and use in data-mining activities.
• Strong scientific writing skills.
• Familiarity with Good Manufacturing Practices (GMP).
• Experience with molecular biology software tools such as Geneius and Sequencher.
• Experience in supporting regulatory submissions including authoring, reviewing, and responding to regulatory questions.

TRAVEL

• Domestic and international travel up to 20% 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: $155,000 - $180,000 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 [click to reveal website link] . Applications accepted on an ongoing basis. 

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 [click to reveal website link] .

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 [click to reveal website link] .

Lundbeck is proud to be an equal opportunity workplace. 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 [click to reveal website link] .

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