Scientist II, Downstream

Job Description

Job Description

Position Summary

Solid Biosciences is seeking an experienced scientist to join our Downstream Process Development (DSPD) team. The DSPD team is responsible for the development, optimization, and technology transfer of the downstream purification processes of Solid’s gene therapy portfolio. The candidate will be a key collaborator in the company’s cross-functional deliverables, working with other groups such as Manufacturing Sciences & Technology for scale-up and tech transfer, Analytical Development in pursuit of industry-leading AAV product quality, Research & Development for designing next-generation purification schemes for novel delivery methods, and Upstream Process Development in the classic two-way collaboration between Process Development’s cell culture and purification sciences teams.

This role will focus on novel research and engineering efforts to invent and/or develop cutting-edge AAV purification technologies with a focus on scalable methods to enrich for high-potent AAV. As Solid continues to advance in the gene therapy space, this task will evolve to additional complex separations (e.g. removal of partially-filled capsids, separation of PTM variants such as deamidated species, and so on). The ability to continuously formulate new DSPD research topics and execute on them experimentally in continued pursuit of industry-leading AAV product quality and manufacturing cost of goods is key.

While this position will focus primarily on novel separations development, there will be ample need for the classical array of DSPD tasks. As such, laboratory mastery of DSPD fixtures such as programming ÄKTA FPLC methods, building and operating TFF skids, statistically-driven Design of Experiments, and sound scale-up principles is a must.

Key Duties & Accountabilities

• Creation and independent execution of downstream experimental designs
• Literature and patent searching for staying abreast of industry trends and IP generation
• Coordination with vendors and external partners to bring in and evaluate promising new technologies
• Planning, setup, and execution with fellow downstream colleagues for high-workload purification deliverables (e.g. pilot runs)
• Statistical interpretation of analytical test results and identification of most logical experimental paths forward
• Collaboration with Research & Development teams to create novel, rationally-designed purification schemes
• Mentorship of junior team members in fundamental downstream techniques and concepts (associate scientists, co-op students)
• Prepare technical reports, presentations, and documentation to support regulatory submissions (e.g., IND filings) and intellectual property development

Qualifications, Experience, and Skills Requirements

• 6+ years working in downstream process development or relevant PhD with 2+ years of industry experience
• ÄKTA (UNICORN) method writing experience
• Deep understanding of industry-standard chromatography (affinity, CEX, AEX, HIC)
• Ability to formulate hypotheses, drive experimental work to key milestones and decision points, and present cost/benefit of continued resource allocation
• TFF skid operation experience
• Well-versed in historical and current analytical / characterization assays for biologics, AAV in particular
• Design of Experiments software experience (e.g. JMP, MODDE, Minitab)
• Data science and model building knowledge (e.g. random forest, nnet, ML/AI)

Preferred Qualifications

• AAV / gene therapy experience a plus
• Deep understanding of AAV biology and structure a plus
• Deep understanding of unorthodox chromatographic modalities (mixed mode, metal affinity, etc.) a plus
• Liquid handling/robocolumn automated chromatography experience a plus
• Tech transfer document writing & transfer to CDMO experience a plus

Travel Commitment

Some travel to external collaborators’ sites may be required; est. up to 10%.