Deciphera Pharmaceuticals
pharmaceutical
Director,CommercialManufacturing&ProcessEngineering
“Director, Commercial Manufacturing & Process Engineering at Deciphera Pharmaceuticals. Skills: Commercial Manufacturing, Process Engineering, CDMO/CMO Management. Lead day-to-day oversight of commercial manufacturing operations. Oversee process engineering activities”
What You'll Achieve.
ensure reliable product supply; ensure regulatory compliance; ensure operational excellence; improve efficiency; reduce costs; enhance manufacturing performance
Industry & Context.
problem-solving skills
Ability to travel up to 30% domestically and internationally
What They're Looking For.
Must Have
10+ years of experience in pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturing, experience managing drug substance and/or drug product manufacturing programs in regulated environments, Demonstrated success working with CDMO/CMO partners and leading cross-functional technical operations initiatives, Deep knowledge of cGMPs, process validation, regulatory CMC requirements, and global drug development processes, leadership, communication, problem-solving, and stakeholder management skills
Nice to Have
Experience authoring and supporting Module 3 CTD submissions through approval and commercialization, Experience supporting oncology and/or orphan disease products, Advanced degree or MBA, Experience with statistical analysis tools such as JMP
What You'll Do.
Lead day-to-day oversight of commercial manufacturing operations
Oversee process engineering activities
Lead continuous improvement initiatives
Drive process optimization
Drive troubleshooting
Drive lifecycle management
Support regulatory CMC strategy
Oversee CDMO/CMO relationships
Partner cross-functionally to support product launches
Partner to support technology transfers
Partner to support supply chain expansion
Partner to support post-approval improvements
Lead operational improvement initiatives
Manage project timelines
How You'll Work.
Team & Collaboration
Partnering cross-functionally with Technical Operations, Quality, Supply Chain, Regulatory; working with external CDMO/CMO partners; Partner cross-functionally to support successful product launches; Partner cross-functionally to support technology transfers; Partner cross-functionally to support supply chain expansion; Partner cross-functionally to support post-approval improvements
Communication Scope
communication skills
Process & Methodology
Manage project timelines, Manage deliverables, Manage budgets
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