Director, Manufacturing Operations

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior manufacturing/engineering leader to drive late-stage to commercial cGMP operations. You will collaborate across regions and with CDMOs to ensure quality, cost efficiency, and on-time delivery for clinical and commercial assets.

The role requires extensive experience in sterile injectable processes, CDMO oversight, and global supply chain planning, with a strong track record in managing teams and complex transfers.

Qualifications

• 10+ years’ experience in late-stage clinical to commercial cGMP manufacturing/engineering/contract manufacturing and/or quality.
• 3+ years of 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).

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.

Skills

Leadership

Project management

Quality investigations

Education

BA/BS in Engineering, Biology, Chemistry, or related field

Job description

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).