Staff Engineer, Upstream Process Development

Job Description

The Staff Engineer, Upstream Process Development is responsible for developing, characterizing, and defining cell culture processes across multiple modes, including fed‑batch, perfusion, and intensified fed‑batch systems. This role supports process development across multiple scales – from microscale through bench and pilot scale – and contributes to both early‑ and late‑stage biotherapeutics programs.

You will collaborate with the technology development team to define new process platforms, drive innovation in upstream development, and lead process activities where needed. The role also involves executing technology transfer into GMP manufacturing environments, supporting regulatory filings, and providing technical expertise in upstream operations and process development strategies.

• Develop, characterize, and optimize cell culture processes across fed‑batch, perfusion, and intensified fed‑batch platforms
• Support upstream development across microscale (Ambr
  15/250), bench‑scale, and pilot‑scale studies
• Contribute to early‑ and late‑stage development programs and take ownership of key upstream work streams as needed
• Partner with technology development teams to define and improve platform processes
• Drive innovation through process improvements and new approaches in upstream development
• Serve as an upstream or bioprocess development lead when needed
• Lead or support technology transfer activities into GMP manufacturing (internal and external), acting as SME and primary point of contact
• 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; may lead small project team

• Bachelor’s degree with 8+ years of experience, Master’s degree with 6+ years, or PhD with relevant experience in chemistry, biology, pharmacy, engineering, or a related field
• 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
• Experience contributing to early‑ and late‑stage process development programs
• Experience supporting regulatory filings and working in cross‑functional teams
• Analytical & Problem Solving: ability to troubleshoot complex process challenges, perform risk assessments, and identify practical solutions
• Collaboration:
  
  strong ability to work across global, cross‑functional teams
• Communication: clear and concise verbal and written communication, including technical documentation and regulatory content
• Organization: strong time management and prioritization skills across multiple projects
• Technical expertise: subject matter expertise in upstream process development, including process characterization, scale‑up, and transfer
• Knowledge sharing: ability to capture and share knowledge to improve processes and team effectiveness
• Project & Resource Management: ability to manage timelines, priorities, and internal/external resources
• Leadership: ability to influence technical decisions, guide cross‑functional teams, and mentor junior colleagues

Location:

Lexington, MA

U.S. Base Salary Range: $116,000 - $182,270

Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.