Associate Director, Downstream Process Development

Summary

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.

Key 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.