Director overseeing cGMP manufacturing operations for Telix, a radiopharmaceutical company developing precision medicines. Managing CDMO strategy, product quality, supply planning, technical transfers, and manufacturing engineers.
Responsibilities
Develop manufacturing and operational plans for commercial and late-stage clinical assets
Collaborate with Regional Operations leadership, Supply Chain, Program leadership, and Directors of CMC Programs
Ensure effective leadership, execution, and delivery of process development and improvement
Ensure contract and regulatory compliance and commercial viability
Plan global production, supply chain, logistics, and distribution
Oversee subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging
Partner with contract manufacturers to ensure quality, deliveries, and costs meet or exceed expectations
Oversee manufacturing, quality, and product development from mid-stage clinical through commercial launch
Develop CDMO strategies for cost savings, supply redundancy, and process improvement
Manage complex technical issues and support quality investigations and non-conformances
Lead and manage manufacturing engineers, including coaching and performance management
Serve as technical lead for supplier and contracting-organization business reviews
Oversee technical transfers and process validation at internal and external CDMOs
Requirements
BA or BS degree in Engineering, Biology, Chemistry, or other relevant field
10+ years combined experience in late-stage clinical to commercial cGMP Manufacturing, Engineering, Contract Manufacturing, and/or Quality
3+ years of previous management experience
Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both clinical and commercial products
Direct experience in Secondary Packaging of Parenteral drugs preferred
Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred
Experience working with International Contract Manufacturing Organizations
Ability to travel approximately 30%—both domestically and internationally
Strong communication, collaboration, adaptability, and ethical behavior
Commitment to continuous learning and professional development
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