Staff Engineer, Process Development

About the role

The Staff Engineer, Downstream Process Development is responsible for developing, characterizing, and defining purification processes for biotherapeutics. This role supports process development across multiple scales - from microscale to bench and pilot scale - and contributes to both early- and late-stage programs.

Responsibilities

• Develop, characterize, and optimize purification processes for biotherapeutics
• Support downstream development across microscale, bench-scale, and pilot-scale studies
• Contribute to both early-stage and late-stage development programs
• Partner with technology development teams to define and advance new process platforms
• Drive innovation through process improvements and new approaches
• Serve as a downstream or bioprocess 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, data generation, and section authoring
• Analyze complex data sets to identify trends and resolve process challenges
• Apply expertise in chromatography, harvest operations, UF/DF, and viral clearance in development and troubleshooting
• Collaborate with external partners and contract development/manufacturing organizations
• Coach and support junior team members; may lead small project teams

Requirements

• Bachelor’s degree with 8+ years, Master’s degree with 6+ years, or PhD with relevant experience in chemistry, biology, pharmacy, engineering, or related field
• Experience in CMC development of biotherapeutics under GMP standards
• Strong understanding of current Good Manufacturing Practices (cGMP)
• Experience working with external partners or contract manufacturing organizations
• Experience contributing to regulatory filings
• Proven ability to work effectively within cross-functional teams

Qualifications

• Analytical & Problem Solving: Ability to troubleshoot complex issues and identify practical solutions
• Collaboration: Strong ability to work across global, cross-functional teams
• Communication: Clear and audience-appropriate verbal and written communication, including technical documentation and presentations
• Organization: Strong prioritization and time management skills across multiple projects; highly self-motivated
• Technical Expertise: Subject matter expertise in downstream process development; ability to contribute across multiple scientific areas
• 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
• External Engagement: Participation in the scientific community (e.g., publications, presentations, conferences) and collaboration with vendors
• Leadership: Ability to influence, guide, and mentor others to support departmental and organizational objectives

Skills

• Analytical & Problem Solving: Ability to troubleshoot complex issues and identify practical solutions
• Collaboration: Strong ability to work across global, cross-functional teams
• Communication: Clear and audience-appropriate verbal and written communication, including technical documentation and presentations
• Organization: Strong prioritization and time management skills across multiple projects; highly self-motivated
• Technical Expertise: Subject matter expertise in downstream process development; ability to contribute across multiple scientific areas
• 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
• External Engagement: Participation in the scientific community (e.g., publications, presentations, conferences) and collaboration with vendors
• Leadership: Ability to influence, guide, and mentor others to support departmental and organizational objectives

Benefits

At Takeda, we are committed to providing competitive compensation and benefits. For Location: Lexington, MA, the U.S. Base Salary Range is $116,000.00 - $182,270.00. Employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. Employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Pay

For Location: Lexington, MA, the U.S. Base Salary Range is $116,000.00 - $182,270.00.

Schedule

Full time