CMC Product Leader, Senior Director - T1D

Scorpion Therapeutics; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Hybrid work options

Job summary

Scorpion Therapeutics seeks a Senior Director, CMC Product Leader (T1D) for cell therapy to drive integrated CMC strategies across development, scale-up, validation, and regulatory submissions.

You will lead cross-functional teams, partner with Regulatory, Manufacturing, Quality, and Clinical groups, and guide lifecycle management, risk mitigation, and IND/CTA experiences.

Qualifications

• Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related field.
• 10+ years in CMC development and manufacturing in biotech/pharma.
• Director or Senior Director level leadership; regulatory submissions and scale-up experience.

Responsibilities

• Lead cross-functional teams covering development, tech transfer, manufacturing readiness, regulatory strategy, and lifecycle management.
• Partner with stakeholders across BiopharmSci CGT, Manufacturing, Quality, Regulatory, Clinical, and Commercial functions.
• Guide technology transfer, manufacturing scale-up, and risk mitigation.
• Prepare CMC content for regulatory filings.
• Manage budgets and resources.

Skills

Leadership

Cross-functional collaboration

Regulatory strategy

Process development

Education

Advanced degree in Chemical Engineering / Biotechnology / Biochemistry

PhD or MBA

Job description

Role:

Senior Director, CMC Product Leader (T1D) for cell therapy; responsible for developing and executing integrated CMC strategies across development, scale-up, validation, regulatory submission, and commercialization.

Core responsibilities

• leading cross-functional teams covering process and analytical development, technology transfer, manufacturing readiness, regulatory strategy, and lifecycle management
• partnering with stakeholders across BiopharmSci CGT, Manufacturing, Quality, Regulatory, Clinical, and Commercial functions
• guiding technology transfer, manufacturing scale-up, and risk mitigation
• preparing CMC content for regulatory filings
• managing budgets and resources

Requirements

• Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related field
• 10+ years in CMC development and manufacturing within biotech/pharma, with significant cell therapy or regenerative medicine experience
• proven leadership at Director or Senior Director level
• experience with process development, regulatory submissions, and manufacturing scale-up

Preferred

• PhD or MBA
• experience in process validation, regulatory interactions, and commercialization of complex biologics

HighValue

• cell therapy
• regenerative medicine
• CMC development
• process transfer
• regulatory strategy
• scale-up
• validation
• IND/CTA/submission experience

WorkSetup

• Hybrid or on-site
• flexible work arrangements