CMC Digital Transformation Lead

Alnylam Pharmaceuticals, Inc.; Cambridge (MA); Hybrid; USD 172,000 - 233,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off and wellness days

Job summary

Alnylam Pharmaceuticals, Inc. seeks an Associate Director of CMC Technology Delivery to lead digital enablement across starting material, drug substance, and drug product processes. The role partners with IT, data teams and external suppliers to design scalable CMC data platforms and AI-enabled workflows.

You will ensure GxP compliance, data integrity, and SDLC governance while driving faster development cycles from preclinical to commercial launch in a hybrid Cambridge, MA setting.

Qualifications

• Bachelor’s degree in Science, Engineering, IT or related field.
• 10+ years in CMC, Process Engineering or IT in biopharma/life sciences.
• Experience with regulatory filing processes and data structures.
• Experience with data integration, analytics and system upgrades.

Responsibilities

• Define and execute the IT solutions roadmap for CMC digital transformation.
• Oversee lifecycle management of digital CMC solutions for regulatory filings to launch.
• Drive AI/ML capabilities enabling faster regulatory authoring and data insights.

Skills

CMC knowledge

Digital transformation

Regulatory filing

SDLC

Stakeholder management

Data/AI familiarity

Education

Bachelor’s degree in Science/Engineering/IT

Master’s/MBA/PhD preferred

Tools

Jira

EDI/APIs

Job description

Alnylam Pharmaceuticals, Inc. seeks an Associate Director of CMC Technology Delivery to lead digital enablement across starting material, drug substance, and drug product processes. The role partners with IT, data teams and external suppliers to design scalable CMC data platforms and AI-enabled workflows.

You will ensure GxP compliance, data integrity, and SDLC governance while driving faster development cycles from preclinical to commercial launch in a hybrid Cambridge, MA setting.