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Associate Director, Downstream Process Development

Associate Director, Downstream Process Development

EPM ScientificBoston, MA, US
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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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