Software Engineer

• accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product
• responsible for advancing the company's biologics portfolio
• responsible for on-time, end-to-end execution of DCT deliverables including robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve uninterrupted long-term supply
• lead DCT and critically assess all team deliverables & foster a learning and collaborative environment
• analyze and develop innovative solutions to unforeseen circumstances
• ensure the best science and most robust processes are used
• conducts options analysis and provides recommendation to governance for endorsement
• represent CMC and effectively communicate across governance bodies, stakeholders and teams
• drive outcomes/decisions through influence, advocacy, & negotiation with stakeholders
• identify options to balance Speed/Cost/Robustness & achieve target commercial product

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