Dir, Engineering, CMC Leader for Biologics

The Development and Commercialization Team (DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.

Requirements

• Responsible for on-time, end-to end execution of DCT deliverables
• Lead DCT and foster a learning and collaborative environment
• Critically assesses all team deliverables and prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines
• Analyze and develop innovative solutions to unforeseen circumstances
• Responsible to ensure the best science and most robust processes are used, working closely with DCRC
• Represent CMC and effectively communicates across the 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
• Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days