Staff Engineer, Upstream Process Development

Responsibilities

• Develop, characterize, and optimize cell culture processes across fed-batch, perfusion, and intensified fed-batch platforms
• Support upstream development across microscale (Ambr15/250), bench-scale, and pilot-scale studies
• Lead or support technology transfer activities into GMP manufacturing environments, acting as a Subject Matter Expert
• Contribute to early- and late-stage development programs and take ownership of key upstream workstreams
• Support regulatory filings through technical documentation and data generation
• Analyze complex data sets to identify trends and resolve process development challenges
• Coach and support junior team members and lead small project teams

Requirements

• Bachelor’s degree with 8+ years of experience, Master’s degree with 6+ years of experience, or PhD with relevant experience in chemistry, biology, pharmacy, or engineering
• Extensive experience in upstream process development for mammalian cell culture under cGMP standards
• Strong hands-on experience with fed-batch, perfusion, and intensified fed-batch systems
• Experience working across microscale, bench-scale, and pilot-scale bioreactor platforms
• Proven experience contributing to early- and late-stage process development programs
• Experience supporting regulatory filings and working within cross-functional teams

Preferred Qualifications

• Ability to troubleshoot complex process challenges and perform risk assessments
• Strong technical writing skills for regulatory content and documentation
• Experience managing timelines, priorities, and both internal and external resources

Benefits

• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off and well-being benefits

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything they do. Driven by the values of Integrity, Fairness, Honesty, and Perseverance, Takeda strives to deliver better health and a brighter future through leading innovation in medicine.