SUMMARY:Lundbeck Seattle's Center of Excellence located in Bothell, Washington is seeking a highly motivated and experienced Senior Scientist to join the Formulation Development team.
The successful candidate will possess extensive knowledge and industrial experience in biologic drug product formulation development, with expertise in developing stable protein formulations to support clinical and late-stage development. The candidate will demonstrate a strong understanding of protein stability, degradation mechanisms, formulation optimization, and drug product development to advance therapeutic biologics from early development through commercialization.
The ability to maintain scientific excellence, independently drive complex development activities, meet project timelines, and effectively influence cross-functional stakeholders is essential. The successful candidate will serve as a Subject Matter Expert (SME) in formulation development, collaborate closely with internal development teams and external manufacturing partners, contribute to regulatory submissions, and represent Formulation Development on multidisciplinary project teams.
ESSENTIAL FUNCTIONS:- Develop robust formulations for biologic drug products, including liquid formulations and, when appropriate, lyophilized dosage forms.
- Design, execute, and interpret formulation screening studies using statistical Design of Experiments (DOE) methodologies and software such as JMP.
- Evaluate protein physical and chemical stability using a broad range of analytical techniques and collaborate closely with Analytical Development to characterize degradation pathways.
- Collaborate with internal teams and external manufacturing partners to support formulation development, drug product process development, technology transfer, and scale-up activities.
- Manage outsourced formulation development activities and provide technical oversight for drug product development at Contract Manufacturing Organizations (CMOs).
- Author and review formulation development reports, protocols, technical documents, and regulatory documentation supporting programs from IND through BLA submissions.
- Present scientific data and project updates to cross-functional teams and senior management.
- Collaborate closely with Upstream, Downstream, Analytical Development, Quality, Regulatory Affairs, Manufacturing, and external partners to advance project objectives.
- Identify opportunities to improve formulation development workflows through implementation of new technologies and innovative approaches.
- Maintain high standards of laboratory safety, documentation, and data integrity.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS:- Ph.D. with 5+ years of relevant experience in the biopharmaceutical industry, or M.S. with 10+ years, or B.S. with 12+ years, or equivalent combination of education and experience.
- Demonstrated expertise in biologic drug product formulation development.
- Strong understanding of protein structure, stability, aggregation mechanisms, and degradation pathways.
- Experience designing and executing high-throughput formulation screening studies using DOE.
- Hands-on experience with analytical characterization techniques including SEC-HPLC, IEX-HPLC, DLS, MFI or HIAC, and related protein characterization methods.
- Demonstrated ability to independently manage laboratory studies, analyze complex datasets, and accurately document results.
- Strong scientific problem-solving, communication, and collaboration skills.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:- Experience with lyophilized biologic drug products and lyophilization process development is desirable.
- Experience supporting commercial or late-stage biologics development.
- Working knowledge of JMP or equivalent statistical software.
- Experience authoring and reviewing CMC sections for regulatory submissions (IND, BLA, MAA).
- Familiarity with GMP manufacturing and Quality systems.
- Strong scientific writing skills.
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: $160,000 - $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 site. Applications accepted on an ongoing basis. #LI-LM1
