EPM Scientific
Associate Director, Downstream Process Development
EPM Scientific, Boston, Massachusetts, us, 02298
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
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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
#J-18808-Ljbffr