Team Leader Downstream Process Development
Bothell, WA, United States
- Healthcare
- Full-time
- downstream process development
- biologics purification
- biotechnology
The Team Leader Downstream Process Development at Lundbeck Seattle BioPharmaceuticals leads the design, optimization, and scale-up of purification processes for biologics within a cross-functional team. This role manages downstream process development operations, ensuring compliance with regulatory standards while fostering innovation and efficient production. The position requires extensive experience in biotechnology or pharmaceutical industries, with expertise in process optimization, technology transfer, and regulatory adherence.
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.
Summary:
The Team Lead, Downstream Process Development, is responsible for leading and managing the downstream process development function at LuSBP. This role focuses on advancing pipeline projects by working cross-functionally with key stakeholder groups, including Upstream Process Development, Formulation Development, Analytical Development, Process Sciences, and Research. The position ensures alignment with organizational goals and regulatory standards while fostering innovation and efficiency in downstream processing.
Essential Functions:
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Lead the downstream process development team to design, optimize, and scale purification processes for biologics.
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Support production of non-GMP materials as needed, including production of tox study material in the 200L pilot plant facility.
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Mentor and develop team members, fostering a culture of innovation, accountability, and continuous improvement.
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Manage project timelines, budgets, and resources to align with organizational objectives.
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Collaborate cross-functionally with Upstream Process Development, Formulation Development, Analytical Development, Process Sciences, and Research to ensure seamless integration of pipeline projects.
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Develop and implement strategies for innovation, process optimization and troubleshooting to enhance efficiency and product quality.
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Provide technical leadership and guidance in chromatography, filtration, and analytical techniques used in downstream processing.
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Ensure adherence to FDA, EMA, ICH guidelines, and other relevant regulatory requirements.
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Support Process Sciences in technology transfer activities to GMP manufacturing facilities, ensuring compliance with regulatory standards.
Required Education, Experience, and Skills:
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Accredited bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field
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10+ years of relevant experience within the biotechnology or pharmaceutical industry.
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Experience in downstream process development
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Demonstrated success in leading teams and managing projects related to purification processes, scale-up, and GMP manufacturing.
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Hands-on experience with process optimization, technology transfer, and troubleshooting downstream processes.
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Familiarity with regulatory guidelines (FDA, EMA, ICH) and quality standards.
Preferred Education, Experience, and Skills:
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Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
Travel:
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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: $245,000 - $285,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. 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 career site. Applications accepted on an ongoing basis. #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. 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.
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