Director, Manufacturing Operations
Telix Pharmaceuticals Limited
August 29, 2026
Remote friendly (United States)
United States
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.
- Drive process development and improvement to support contract/regulatory compliance and commercial viability.
- Ensure global production and supply chain/logistics/distribution planning to support clinical and commercial needs.
- Oversee subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging.
- Partner with contract manufacturers to ensure quality, delivery, and cost expectations are met.
- Provide oversight from mid-stage clinical through commercial launch; sustain/monitor/improve CDMO strategies.
- Define strategies for cost savings, supply redundancy, and process improvement within the CDMO network.
- Develop manufacturing and capacity strategies aligned to current/future marketing plans.
- Manage complex technical issues; support quality investigations and non-conformances.
- Lead, develop, and manage manufacturing engineers; lead supplier business reviews.
- Oversee technical transfers and process validation at internal and external CDMOs.
Qualifications:
- BA/BS in Engineering, Biology, Chemistry, or relevant field.
- 10+ years in late-stage clinical to commercial cGMP manufacturing/engineering/contract manufacturing/quality.
- 3+ years management experience.
- Experience in sterile injectable filling and lyophilization for clinical/commercial products.
- Secondary packaging of parenteral drugs (preferred).
- Complex formulations/bulk drug substance/biologic manufacturing (preferred).
- Experience with international CDMOs.
- Ability to travel ~30%.
Key benefits: competitive salaries, annual performance bonuses, equity incentive, generous vacation, paid wellness days, and learning & development support.
- 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.
- Drive process development and improvement to support contract/regulatory compliance and commercial viability.
- Ensure global production and supply chain/logistics/distribution planning to support clinical and commercial needs.
- Oversee subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging.
- Partner with contract manufacturers to ensure quality, delivery, and cost expectations are met.
- Provide oversight from mid-stage clinical through commercial launch; sustain/monitor/improve CDMO strategies.
- Define strategies for cost savings, supply redundancy, and process improvement within the CDMO network.
- Develop manufacturing and capacity strategies aligned to current/future marketing plans.
- Manage complex technical issues; support quality investigations and non-conformances.
- Lead, develop, and manage manufacturing engineers; lead supplier business reviews.
- Oversee technical transfers and process validation at internal and external CDMOs.
Qualifications:
- BA/BS in Engineering, Biology, Chemistry, or relevant field.
- 10+ years in late-stage clinical to commercial cGMP manufacturing/engineering/contract manufacturing/quality.
- 3+ years management experience.
- Experience in sterile injectable filling and lyophilization for clinical/commercial products.
- Secondary packaging of parenteral drugs (preferred).
- Complex formulations/bulk drug substance/biologic manufacturing (preferred).
- Experience with international CDMOs.
- Ability to travel ~30%.
Key benefits: competitive salaries, annual performance bonuses, equity incentive, generous vacation, paid wellness days, and learning & development support.