Manager CMC Program Operations

Scorpion Therapeutics; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks a CMC Program Operations Manager to lead digital transformation and drive operational excellence in cell & gene therapy development. You will build integrated project plans and design AI-enabled tools to automate reporting and risk management.

You will coordinate with Regulatory, Manufacturing, Quality and Supply Chain teams, monitor regulatory commitments, and push for standardized workflows and digital solutions to increase transparency and efficiency across

Qualifications

• 6+ years in biopharma/life sciences with at least 2 years in CMC or operations project management.
• Proficiency with MS Project or Smartsheet.
• Experience with AI/automation tools and scripting.
• Knowledge of GMP and regulatory landscape in cell & gene therapy.

Responsibilities

• Develop and maintain integrated project plans.
• Design AI-enabled tools to automate reporting and risk management.
• Oversee cross-functional coordination with Regulatory, Manufacturing, Quality, and Supply Chain teams; track regulatory commitments.
• Drive process modernization through digital solutions, establish standardized workflows, and lead operational projects to improve transparency and efficiency.

Skills

Project management

Cross-functional coordination

Process improvement

Education

Bachelor's degree in a relevant field

Tools

MS Project

Smartsheet

Generative AI

Low-code platforms

Scripting

Job description

Role: CMC Program Operations Manager leading digital transformation and operational excellence in biopharma, specifically within cell & gene therapy development.

Responsibilities

Develop and maintain integrated project plans, design AI-enabled tools to automate reporting and risk management, oversee cross-functional coordination with Regulatory, Manufacturing, Quality, and Supply Chain teams, and track regulatory commitments. Drive process modernization through digital solutions, establish standardized workflows, and lead operational projects to improve transparency and efficiency.

Requirements

Bachelor’s in a relevant field; 6+ years in biopharma/life sciences with at least 2 years in CMC or operations project management; strong skills in project management software (MS Project, Smartsheet), and AI/automation tools (generative AI, low-code platforms, scripting); working knowledge of GMP, quality systems, supply chain, regulatory landscape in cell & gene therapy.

Preferred

PMP certification, hands-on experience deploying AI tools for operational reporting.

HighValue

focus on CMC development for cell & gene therapies, digital tool deployment, risk management, cross-functional collaboration, fast-paced environment.

WorkSetup

not specified; physical requirements N/A.