Team Leader Downstream Process Development

Lundbeck • Bothell, WA

6d • $245,000 - $285,000

About The Position

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.

Requirements

• Accredited bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field
• 10+ years of relevant experience within the biotechnology or pharmaceutical industry.
• Experience in downstream process development
• Demonstrated success in leading teams and managing projects related to purification processes, scale-up, and GMP manufacturing.
• Hands-on experience with process optimization, technology transfer, and troubleshooting downstream processes.
• Familiarity with regulatory guidelines (FDA, EMA, ICH) and quality standards.

Nice To Haves

• Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field

Responsibilities

• Lead the downstream process development team to design, optimize, and scale purification processes for biologics.
• Support production of non-GMP materials as needed, including production of tox study material in the 200L pilot plant facility.
• Mentor and develop team members, fostering a culture of innovation, accountability, and continuous improvement.
• Manage project timelines, budgets, and resources to align with organizational objectives.
• Collaborate cross-functionally with Upstream Process Development, Formulation Development, Analytical Development, Process Sciences, and Research to ensure seamless integration of pipeline projects.
• Develop and implement strategies for innovation, process optimization and troubleshooting to enhance efficiency and product quality.
• Provide technical leadership and guidance in chromatography, filtration, and analytical techniques used in downstream processing.
• Ensure adherence to FDA, EMA, ICH guidelines, and other relevant regulatory requirements.
• Support Process Sciences in technology transfer activities to GMP manufacturing facilities, ensuring compliance with regulatory standards.

Benefits

• flexible paid time off (PTO)
• health benefits to include Medical, Dental and Vision
• company match 401k

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees