Senior Director, CMC Team Leader

Scorpion Therapeutics; United States; Remote; USD 250,000 - 350,000; Full time

Job summary

Cabaletta Bio is seeking a Senior Director, CMC Team Leader to provide strategic leadership of Chemistry, Manufacturing, and Controls for late-stage autologous cell therapy programs.

You will lead cross-functional teams, shape development and regulatory strategies, drive process development, validation, and comparability, and manage regulatory submissions like INDs, BLAs, and MAAs, coordinating with manufacturing and supply chain for commercialization readiness.

Qualifications

• PhD, MS, or equivalent in life sciences or engineering.
• 12+ years of biotech/pharma CMC experience, including biologics and cell/gene therapy.
• Prior leadership in cross-functional program teams.
• Deep knowledge of GMP, regulatory standards, and biologic development.

Responsibilities

• Lead cross-functional CMC teams.
• Develop integrated development and regulatory strategies.
• Drive process development, validation, and comparability.
• Manage regulatory submissions including INDs, BLAs, and MAAs.
• Coordinate with manufacturing and supply chain for commercialization readiness.

Skills

CMC Leadership

Cross-Functional Leadership

Regulatory Strategy

GMP Compliance

Education

PhD, MS, or equivalent in life sciences or engineering

Job description

Senior Director, CMC Team Leader responsible for strategic leadership of Chemistry, Manufacturing, and Controls (CMC) activities for late-stage autologous cell therapy programs at Cabaletta Bio.

Objectives

oversee development from clinical to commercial phases, ensure regulatory compliance, and support product launch and lifecycle management.

Responsibilities

• lead cross-functional CMC teams
• develop integrated development and regulatory strategies
• drive process development, validation, and comparability
• manage regulatory submissions including INDs, BLAs, and MAAs
• coordinate with manufacturing and supply chain for commercialization readiness

Qualifications

• PhD, MS, or equivalent in life sciences or engineering
• 12+ years of biotech/pharma CMC experience, including biologics and cell/gene therapy
• prior leadership in cross-functional program teams
• deep knowledge of GMP, regulatory standards, and biologic development

Preferred

• experience supporting BLA/MAA submissions, commercialization, and late-stage clinical programs
• familiarity with autologous cell therapies

High-Value

• biologics
• cell/gene therapies
• autologous products
• late-stage development
• regulatory strategy
• global filings
• process validation
• lifecycle management

Collaboration

• Process Development
• Analytical Development
• Quality
• Regulatory
• Supply Chain
• Program teams

Work setup

Remote; no specific travel requirements stated.