As the mAb lead for clinical programs, this position will be responsible for supporting regulatory approval of biologics drug substances by leading technical teams throughout Phase 1, Phase 2, and Phase 3 development and authoring Chemistry, Manufacturing, and Controls (CMC) filing content.  

 Responsibilities: 

• Accountable for driving CMC development plans in collaboration with technical functions and in alignment with overall program objectives. 
• Ensures technical rigor and is accountable for team performance and technical deliverables of the project. 
• Leads technical issue resolution and implements robust solutions that are aligned cross-functionally. 
• Ensures phase appropriate control strategy based on timelines and project risks.  
• Schedules technical team meetings, develops agendas, issues program highlights, and drives project timelines to ensure successful process development and regulatory submission. 
• Works with the functional area leads to assemble content for technical reviews. 
• Apprises CMC and PDS&T management of plans and risks through regular communications and periodic reviews throughout development. 
• Responsible for the preparation and review of regulatory filings. Responds to urgent regulatory queries. 
• Serves as spokesperson for the drug substance CMC project team on cross-functional product teams and ensures information flow among line functions.  
• Manages projects utilizing a matrix management approach.