Senior Director, Downstream Process Development

EPM Scientific; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

A leading biopharmaceutical organization is seeking an Associate Director of Downstream Process Development to oversee purification processes for biologic drug substances. The ideal candidate will have significant experience in downstream process development and lead a team in a dynamic environment. Proficiency in Mandarin and a strong background in regulatory compliance are crucial for this role, which offers full-time employment in a strategic science function.

Qualifications

• 10+ years of experience in downstream process development for biologics if Ph.D.
• 12+ years for MS, 15+ years for BS.
• Fluency in Mandarin Chinese is required.

Responsibilities

• Lead the design and optimization of downstream purification processes.
• Manage technology transfer activities and support manufacturing operations.
• Contribute to regulatory documentation for IND/BLA submissions.
• Drive innovation through new technology implementation.
• Participate in strategic planning and departmental growth initiatives.

Skills

Leadership

Strategic thinking

Collaboration

Problem-solving

Communication

Regulatory compliance

Technical documentation

Education

Ph.D., MS, or BS in biology, biochemistry, biochemical engineering, or related field

Tools

AKTA purification systems

Statistical software (JMP, Minitab, Design Expert)

Microsoft Office tools

Job description

A leading biopharmaceutical organization is seeking an Associate Director of Downstream Process Development to oversee purification processes for biologic drug substances. The ideal candidate will have significant experience in downstream process development and lead a team in a dynamic environment. Proficiency in Mandarin and a strong background in regulatory compliance are crucial for this role, which offers full-time employment in a strategic science function.