Associate Director, CMC Technology Delivery
Alnylam Pharmaceuticals
August 12, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Define and execute the IT solutions roadmap aligned with CMC business priorities and digital transformation goals.
- Oversee implementation and lifecycle management of digital CMC solutions to accelerate speed-to-market from DC declaration through IND/NDA filings to commercial launch.
- Drive digital and AI/ML capabilities for faster regulatory authoring, tech transfer, reduced errors, and data-driven insights.
- Collaborate with CMC and IT Data/AI teams to create, transform, store, and model process/transactional data (lab runs, DOE, batch execution) and derived statistical/trending outputs.
- Deploy standardized process recipe data structures for CPPs/CQAs/in-process controls, ranges, and recipe/version management; support tech transfer through PPQs.
- Partner to develop CMC statistics data assets, trending tools lifecycle, and process/product control strategy.
- Enable CMC program management digital capabilities (transfer from R&D, start-up, advancement, status reporting).
- Develop data products, templates/procedures, and seamless API/EDI system integrations for exchange of process data with CMO and partners.
- Proliferate user adoption of data/AI/statistical analytics across regulatory and commercial use cases.
- Establish process data governance/stewardship and process data products on the enterprise platform.
- Own end-to-end lifecycle of CMC applications (strategy/design through deployment, sustainment, upgrades, continuous improvement, retirement); manage TCO.
- Ensure GxP/data integrity and global regulatory compliance; maintain audit readiness.
- Drive operational excellence and high-quality support for CMC systems; lead/mentor cross-functional teams.
Qualifications:
Required:
- BS in Science/Engineering/IT (or related).
- 10+ years experience in CMC, Process Engineering, or IT client-facing roles in biopharma/life sciences.
- Experience with regulatory filings, recipe unit operations/data structures, statistical software/trending tools (e.g., JMP, Minitab, R, Python, etc.).
- Stakeholder management, change/transformation leadership.
- Data/systems integration and experience managing IT suppliers.
- Regulated environments: GxP, CSV, FDA 21 CFR.
- Full SDLC knowledge.
- Demonstrated success leading cross-functional teams.
- Strategic/pragmatic delivery mindset; ~10% travel.
Preferred:
- MS/MBA/PhD.
- Knowledge of EDI, APIs, system integration, data transfers.
- Agile/Scrum; Jira or similar.
- Familiarity with emerging AI/data/digital capabilities (data models, lakehouse, knowledge graphs, agentic AI, LLMs).
- Define and execute the IT solutions roadmap aligned with CMC business priorities and digital transformation goals.
- Oversee implementation and lifecycle management of digital CMC solutions to accelerate speed-to-market from DC declaration through IND/NDA filings to commercial launch.
- Drive digital and AI/ML capabilities for faster regulatory authoring, tech transfer, reduced errors, and data-driven insights.
- Collaborate with CMC and IT Data/AI teams to create, transform, store, and model process/transactional data (lab runs, DOE, batch execution) and derived statistical/trending outputs.
- Deploy standardized process recipe data structures for CPPs/CQAs/in-process controls, ranges, and recipe/version management; support tech transfer through PPQs.
- Partner to develop CMC statistics data assets, trending tools lifecycle, and process/product control strategy.
- Enable CMC program management digital capabilities (transfer from R&D, start-up, advancement, status reporting).
- Develop data products, templates/procedures, and seamless API/EDI system integrations for exchange of process data with CMO and partners.
- Proliferate user adoption of data/AI/statistical analytics across regulatory and commercial use cases.
- Establish process data governance/stewardship and process data products on the enterprise platform.
- Own end-to-end lifecycle of CMC applications (strategy/design through deployment, sustainment, upgrades, continuous improvement, retirement); manage TCO.
- Ensure GxP/data integrity and global regulatory compliance; maintain audit readiness.
- Drive operational excellence and high-quality support for CMC systems; lead/mentor cross-functional teams.
Qualifications:
Required:
- BS in Science/Engineering/IT (or related).
- 10+ years experience in CMC, Process Engineering, or IT client-facing roles in biopharma/life sciences.
- Experience with regulatory filings, recipe unit operations/data structures, statistical software/trending tools (e.g., JMP, Minitab, R, Python, etc.).
- Stakeholder management, change/transformation leadership.
- Data/systems integration and experience managing IT suppliers.
- Regulated environments: GxP, CSV, FDA 21 CFR.
- Full SDLC knowledge.
- Demonstrated success leading cross-functional teams.
- Strategic/pragmatic delivery mindset; ~10% travel.
Preferred:
- MS/MBA/PhD.
- Knowledge of EDI, APIs, system integration, data transfers.
- Agile/Scrum; Jira or similar.
- Familiarity with emerging AI/data/digital capabilities (data models, lakehouse, knowledge graphs, agentic AI, LLMs).