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.
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