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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.
You will collaborate with the technology development team to define new process platforms, drive innovation in downstream 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 downstream operations such as chromatography, harvest, ultrafiltration/diafiltration (UF/DF), and viral clearance, with potential exposure to bioconjugation.
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
Education & Experience
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
Knowledge & 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
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Takeda is proud in its commitment 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.
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Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MAU.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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. U.S. based 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.
EEO Statement
Takeda is proud in its commitment 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.
Job Exempt
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