Team Leader Downstream Process Development jobs in United States
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Lundbeck · 1 day ago

Team Leader Downstream Process Development

Lundbeck is a global biopharmaceutical company focused on advancing brain health. The Team Leader, Downstream Process Development, will lead the downstream process development function, ensuring alignment with organizational goals and regulatory standards while fostering innovation and efficiency in downstream processing.

Health CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote
Hiring Manager
Laurie Meninno
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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

Qualification

Downstream process developmentPurification processesGMP manufacturingProcess optimizationTechnology transferRegulatory guidelinesAnalytical techniquesTeam leadershipProject managementMentoring

Required

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

Preferred

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

Benefits

Flexible paid time off (PTO)
Health benefits to include Medical, Dental and Vision
Company match 401k

Company

Lundbeck

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Lundbeck is a pharmaceutical company that develops products to treat people with psychiatric and neurological disorders.

H1B Sponsorship

Lundbeck has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)

Funding

Current Stage
Public Company
Total Funding
$566.37M
Key Investors
Michael J. Fox Foundation
2025-05-22Post Ipo Debt· $566.37M
2020-03-04Grant
1999-06-18IPO

Leadership Team

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Maria Alfaiate
Executive Vice President Commercialisation and Corporate Strategy
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Torben Frandsen
Vice President
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Company data provided by crunchbase