Senior Scientist Formulation 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 Formulation Development team. In this role you will have the opportunity work closely with scientists in teams from Upstream, Downstream, 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 a technical capacity as Subject Matter Expert (SME) with a deep understanding of biologic Formulation Development, including lyophilized biologic formulations. Strong bench, analytical and oral/written communication skills are expected.

ESSENTIAL FUNCTIONS:

• Primarily onsite laboratory-based role.
• Develop stable lyophilized and liquid biologic formulations
• Design and execute formulation screening experiments using statistical software (e.g. JMP)
• Work closely with Contract Research and Manufacturing Organizations in developing lyophilized formulations and processes, including process scale-up, cycle optimization and technology transfer.
• Present data and actively participate in discussions on experimental design, analysis, and conclusions
• Author and review protocols and development reports to support projects from early to later stages of development
• Represent the Formulation Development 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.
• Experienced in Formulation Development of liquid or lyophilized biologic drug products
• Strong understanding of protein structure, protein physical & chemical stability, or degradation pathways relevant to biologic therapeutic drug products.
• Experienced with planning and executing Design of Experiments (DOE) high-throughput formulation screenings
• Experienced with HPLC chromatography (SEC and IEX), MFI or HIAC for subvisible particle analysis, or light scattering.
• Demonstrated ability to manage effectively and independently laboratory work and screening data in appropriate databases for trending purposes.
• Excellent interpersonal skills. Demonstrated ability to collaborate in focused Formulation Development team and multi-disciplinary matrixed team environments.

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

• Deep expertise in Formulation Development of lyophilized biologic drug product
• Strong scientific writing and communication skills
• Experience in supporting regulatory submissions including authoring, reviewing, and responding to regulatory questions

TRAVEL:

• Willingness/Ability to travel up to 10% domestically. International travel 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.