Director, Manufacturing Operations

Responsibilities:
- Develop manufacturing and operational plans for commercial and late-stage clinical assets in collaboration with Regional Operations, Supply Chain, Program leadership, and Directors of CMC Programs.
- Deliver process development and improvement for contract/regulatory compliance and commercial viability.
- Ensure global production, supply chain, logistics, and distribution planning to support clinical and commercial development.
- Partner with contract manufacturers to ensure quality, deliveries, and costs meet Telix expectations.
- Provide oversight from mid-stage clinical through commercial launch (manufacturing, quality, and development).
- Sustain, monitor, and improve internal/external CDMO strategies with CMC Program Directors.
- Determine strategies for cost savings, supply redundancy, and process improvement within the CDMO network.
- Develop manufacturing and capacity strategies aligned to current and future marketing strategies.
- Manage complex technical issues; support quality investigations and non-conformances with product expertise.
- Lead, develop, and manage manufacturing engineering team performance.
- Serve as technical lead for supplier/business reviews.
- Oversee technical transfers and process validation at internal and external CDMOs.

Qualifications & Experience:
- BA/BS in Engineering, Biology, Chemistry, or related field.
- 10+ years’ experience in late-stage clinical to commercial cGMP manufacturing/engineering/contract manufacturing and/or quality.
- 3+ years management experience.
- Direct experience in sterile injectable filling and lyophilization (clinical and commercial).
- Direct experience in secondary packaging of parenteral drugs (preferred).
- Direct experience in complex bulk drug substance and biologic drug substance formulations (preferred).
- Experience with international CDMOs.
- Travel ~30% (domestic and international).