Creative Operations Manager orchestrating resourcing and integrated delivery for GALE, a business agency. Managing creative capacity, staffing, production traffic, and client - facing project execution.
About the role
- 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
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements
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