Director, CMC Technical Program Management

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Perspective Therapeutics seeks a Senior CMC Program Leader to coordinate radiopharmaceutical development, manufacturing, and regulatory activities. You will drive cross-functional plans across CMC, manufacturing, Quality, Regulatory and Supply Chain, ensuring seamless technology transfer and risk mitigation.

Role requires 10+ years in pharma/biotech with deep CMC leadership and regulatory experience, including INDs and NDA/BLA submissions.

Qualifications

• Advanced degree in pharmaceutical sciences or related field.
• 10+ years in pharma/biotech with cross-functional CMC leadership.
• Strong understanding of radiopharmaceuticals, biologics, GMP manufacturing, and regulatory standards (FDA, EMA, ICH).
• Proficiency in project management tools.

Responsibilities

• Develop and execute integrated plans across CMC, manufacturing, Quality, Regulatory and Supply Chain.
• Lead technology transfer and risk management.
• Support regulatory submissions (INDs, NDA/BLA).
• Partner with cross-functional teams to ensure clinical supply continuity.
• Maintain project plans and drive program milestones from development to commercialization.

Skills

Project management tools

Education

MS/PhD/PharmD in pharmaceutical sciences or related field

Job description

Role

Senior CMC Program Leader coordinating radiopharmaceutical development, manufacturing, and regulatory activities within Perspective Therapeutics.

Responsibilities

• develop and execute integrated plans across CMC, manufacturing, Quality, Regulatory, and Supply Chain functions
• lead technology transfer and risk management
• support regulatory submissions (INDs, NDA/BLA)
• partner with cross-functional teams to ensure clinical supply continuity
• maintain project plans and drive program milestones from early development through commercialization

Requirements

• advanced degree (M.S., Ph.D., Pharm.D.) in pharmaceutical sciences or related field
• 10+ years in pharma/biotech with extensive experience leading cross-functional CMC initiatives
• strong understanding of radiopharmaceutical, biologics, or complex therapies, GMP manufacturing, and regulatory standards (FDA, EMA, ICH)
• proficiency in project management tools

Preferred

experience with radiopharmaceuticals, biologics, or gene therapies, and contribution to regulatory filings.

High-Value

• radiopharmaceutical development
• CMC
• technology transfer
• regulatory submissions
• cross-functional leadership
• 30% travel possible

Work Setup

not specified.