Senior Director, Biotherapeutics Downstream Process

JobRx, Inc.; Lexington (MA); Hybrid; USD 212,000 - 333,190; Full time

Benefits offered by this job

Hybrid work policy

Competitive compensation package

Job summary

Takeda in Lexington, MA seeks a senior leader to direct Biotherapeutics Downstream Process Development, overseeing purification strategy from discovery to commercial. You will coordinate internal teams and external partners to meet deliverables and regulatory expectations, preparing CMC sections and IND responses.

You will drive rapid, phase-appropriate development using platform approaches, mentor leaders, and expand external networks to advance technology transfer, scale-up, and GMP compliance

Qualifications

• Ten+ years in biologics downstream process development with leadership
• Experience coordinating with CRO/CMO partners
• Experience preparing regulatory submissions (CMC) and responding to agencies
• Proven track record with technology transfer, scale-up
• Deep expertise in chromatography, filtration, viral clearance, product attributes
• Experience leading IND-driven, platform-based development
• Leadership experience on process development leadership teams
• Strong external network to drive collaborations

Responsibilities

• Lead a multidisciplinary team for purification process development across discovery to commercial
• Set technical strategy with leadership to align priorities and decisions
• Collaborate with upstream, analytical, and drug product teams to streamline development
• Drive standardization and platform improvements across Pharmaceutical Sciences
• Oversee internal and external development activities and transfer readiness
• Prepare and approve CMC sections for regulatory submissions and respond to questions
• Drive rapid, phase-appropriate development toward INDs using platform strategies
• Lead tech transfer, scale-up, and validation for reliable manufacturing
• Ensure GMP and quality systems across teams and partners
• Cultivate external networks and vendors to bring new approaches
• Mentor leaders and scientists, influencing senior leadership on downstream strategy

Skills

Leadership

Cross-functional collaboration

Regulatory strategy

Strategic thinking

Mentoring

Communication

Executive presence

Team building

Education

Advanced degree in biochemical/chemical engineering or related

博士号 preferred

Tools

AI-enabled tools

Automation tools

Job description

Takeda in Lexington, MA seeks a senior leader to direct Biotherapeutics Downstream Process Development, overseeing purification strategy from discovery to commercial. You will coordinate internal teams and external partners to meet deliverables and regulatory expectations, preparing CMC sections and IND responses.

You will drive rapid, phase-appropriate development using platform approaches, mentor leaders, and expand external networks to advance technology transfer, scale-up, and GMP compliance