Senior Scientist, Analytical Development

BrainChild Bio is seeking to hire an Analytical Development Sr. Scientist to add to our growing team. This role will drive and execute potency method development for BrainChild’s products from pre-clinical through late-stage development. The ideal candidate would have experience developing, qualifying, and transferring potency methods for both product release and investigational product characterization. They will be problem solvers and have experience managing analytical method life cycle through transitions as products accelerate through the clinical phases into commercial and analytical methods move from concepts to QC labs. They will collaborate closely with the Research, Process Development, and Clinical teams to understand product attributes and their impacts while suggesting analytical possibilities to help guide product and process development decisions. The role will drive potency method development through the full life cycle from initial development, through transfer and qualification to and with Quality Control at our CDMO partners. As a key member of the CMC development of our products, the Sr Scientist will deliver subject matter expertise and project input to cross functional teams as we build toward future milestones and be a leader in our Analytical Development organization aiding with the development of our team.  

• Lead the development of potency strategy for cell therapy products including but not limited to CAR T cells and lentiviral vectors to support early and late-stage clinical trials. 
• Develop cell-based assay potency methods for QC product release, extended characterization and investigational support for Process Development. 
• Work closely with Research, Process Development, Quality and external manufacturing sites to support early method development, qualification, transfer and life cycle management. 
• Evaluate and onboard innovative analytical technology platforms to streamline future product development efforts. 
• Author ELNS, protocols, reports, SOPs and sections of regulatory filings.  
• Lead method transfers to external manufacturing and testing partners. 
• Mentor and/or manage junior scientific staff. 
• Help build data visualization and statistical analysis tools to help understand method and process robustness and aid in correlative analysis. 

• 8+ years in life sciences supporting or leading analytical development activities with minimally 3 years in cell therapy; years of experience potentially inclusive of time in graduate studies 
• Experience with the development of potency strategy and methods for biological products with a preference for cell therapy experience. 
• Previous experience with method qualification/validation and transfer highly desired. 
• Experience developing cell-based assays with live cell imaging, flow/spectral cytometry, cell counting, and/or multiplex immunoassay endpoints. 
• Strong knowledge of ICH and regulatory requirements for analytical testing and control of cell therapy products and experience as an author and/or reviewer of regulatory submissions. 
• Proficiency with life science data analysis tools (JMP, GraphPad, FlowJo, etc.) and statistical analysis. 
• Experience communicating complex technical messages to cross-functional teams. 
• Previous management experience desired. 
• Ability to travel up to 10% of the time to support tech transfer activities.