Head of Downstream BioProcess Development

Takeda is seeking an experienced and strategic leader to serve as Head of Downstream BioProcess Development in Lexington, MA. This full-time position offers the opportunity to drive innovation and operational excellence in bioprocess development for a global pharmaceutical leader.

Position Summary

The Head of Downstream BioProcess Development will lead the strategic direction and execution of downstream bioprocess development initiatives at Takeda's Lexington facility. Reporting to senior leadership, you will be responsible for overseeing the design, optimization, and scale-up of downstream purification and manufacturing processes for therapeutic biologics. This role is critical in bridging development science with manufacturing operations, ensuring compliance with regulatory standards, and delivering cost-effective solutions that meet quality and timeline objectives.

What You'll Do

• Direct the development and optimization of downstream purification technologies, including chromatography, filtration, and formulation strategies
• Lead cross-functional teams to support process scale-up from laboratory to commercial manufacturing scale
• Establish and drive technical roadmaps aligned with product development timelines and manufacturing requirements
• Collaborate with upstream development, manufacturing, and regulatory affairs to ensure seamless process transfer and compliance
• Oversee technology evaluations and implementation of advanced bioprocess technologies to enhance efficiency and reduce costs
• Mentor and develop high-performing technical teams while fostering a culture of continuous improvement and innovation
• Champion process robustness, analytical methods validation, and quality assurance throughout the downstream development lifecycle

Skills & Qualifications

• Advanced degree (MS or PhD) in Chemical Engineering, Bioengineering, Biotechnology, or related discipline
• 12+ years of progressive experience in biopharmaceutical downstream bioprocess development or manufacturing
• Demonstrated leadership experience managing technical teams and cross-functional projects
• Strong knowledge of downstream purification technologies, process scale-up principles, and GMP manufacturing environments
• Expertise in regulatory requirements including FDA guidance and ICH guidelines for biologics
• Excellent analytical and problem-solving skills with ability to drive data-informed decision-making
• Strong communication skills and ability to influence across organizational levels

Working at Takeda

At Takeda, you'll join a company committed to developing innovative therapies that improve patient outcomes. The Lexington location is home to a talented team of scientists and engineers dedicated to advancing biopharmaceutical development. Takeda values collaboration, scientific excellence, and professional growth, offering a dynamic environment where your expertise will directly impact the development of life-changing medicines.

Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.