Staff Engineer, Process Development
Takeda
June 27, 2026
Remote friendly (Lexington, MA)
United States
$116,000 - $182,270 USD yearly
Operations
About the Role
The Staff Engineer, Downstream Process Development is responsible for developing, characterizing, and defining purification processes for biotherapeutics across microscale to bench and pilot scales, contributing to early- and late-stage programs.
How you will contribute
- 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
- Serve as a downstream/bioprocess lead when needed
- Lead/support technology transfer into GMP manufacturing (internal/external) as SME/primary point of contact
- Support regulatory filings via technical documentation, data generation, and section authoring
- Analyze complex data sets to identify trends and resolve process challenges
- Apply expertise in chromatography, harvest, UF/DF, and viral clearance; potential exposure to bioconjugation
- Collaborate with external partners and CDMOs/CMOs
- Coach/support junior team members; may lead small project teams
What you bring to Takeda
Education & Experience
- Bachelor’s (8+ years), Master’s (6+ years), or PhD (relevant experience) in chemistry, biology, pharmacy, engineering, or related field
- CMC development experience for biotherapeutics under GMP
- Strong cGMP understanding
- Experience with external partners/contract manufacturing organizations
- Experience contributing to regulatory filings
- Ability to work in cross-functional teams
Knowledge & Skills
- Analytical/problem solving
- Collaboration across global, cross-functional teams
- Clear verbal/written communication and technical documentation
- Organization, prioritization, and time management
- Downstream process development expertise across multiple scientific areas
- Knowledge sharing and leadership/mentoring
- Project/resource management
- External scientific engagement (publications/presentations/conferences)
The Staff Engineer, Downstream Process Development is responsible for developing, characterizing, and defining purification processes for biotherapeutics across microscale to bench and pilot scales, contributing to early- and late-stage programs.
How you will contribute
- 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
- Serve as a downstream/bioprocess lead when needed
- Lead/support technology transfer into GMP manufacturing (internal/external) as SME/primary point of contact
- Support regulatory filings via technical documentation, data generation, and section authoring
- Analyze complex data sets to identify trends and resolve process challenges
- Apply expertise in chromatography, harvest, UF/DF, and viral clearance; potential exposure to bioconjugation
- Collaborate with external partners and CDMOs/CMOs
- Coach/support junior team members; may lead small project teams
What you bring to Takeda
Education & Experience
- Bachelor’s (8+ years), Master’s (6+ years), or PhD (relevant experience) in chemistry, biology, pharmacy, engineering, or related field
- CMC development experience for biotherapeutics under GMP
- Strong cGMP understanding
- Experience with external partners/contract manufacturing organizations
- Experience contributing to regulatory filings
- Ability to work in cross-functional teams
Knowledge & Skills
- Analytical/problem solving
- Collaboration across global, cross-functional teams
- Clear verbal/written communication and technical documentation
- Organization, prioritization, and time management
- Downstream process development expertise across multiple scientific areas
- Knowledge sharing and leadership/mentoring
- Project/resource management
- External scientific engagement (publications/presentations/conferences)