Associate 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

Associate Director, Downstream Process Development

We are proud to be partnering with a leading biopharmaceutical organization on an exciting search for an Associate Director of Downstream Process Development. This individual will oversee a team of scientists focused on developing purification processes for biologic drug substances while playing a key role in guiding strategic initiatives and contribute to the expansion of the organization.

Responsibilities

• Lead the design and optimization of downstream purification processes including chromatography, UF/DF, viral clearance, and formulation.
• Manage technology transfer activities and provide hands-on support for manufacturing operations.
• Contribute to regulatory documentation for IND/BLA submissions.
• Drive innovation through new technology implementation and scientific contributions.
• Participate in strategic planning and departmental growth initiatives.
• Mentor team members and oversee budget and resource planning.
• Represent downstream development in client meetings and cross-functional collaborations.
• Ensure compliance with regulatory standards and author technical documentation.

Qualifications

• Advanced degree (Ph.D., MS, or BS) in biology, biochemistry, biochemical engineering, or related field.
• Significant experience in downstream process development for biologics (10+ years for Ph.D., 12+ for MS, 15+ for BS).
• Expertise with AKTA purification systems and chromatography techniques.
• Strong understanding of cGMP environments and regulatory expectations.
• Proven leadership, strategic thinking, and project management capabilities.
• Excellent communication, collaboration, and problem-solving skills.
• Proficiency with statistical software (e.g., JMP, Minitab, Design Expert) and Microsoft Office tools.
• Willingness to work on-site in Shanghai for extended periods.
• Fluency in Mandarin Chinese is required.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing