Associate Director, CMC Technology Delivery
Alnylam Pharmaceuticals
June 30, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Define and execute the IT solutions roadmap for CMC digital transformation.
- Oversee implementation and lifecycle management of digital CMC solutions to speed new pipeline products from Development Candidate through IND/NDA filings to commercial launch.
- Deliver digital and AI/ML capabilities for faster regulatory authoring and reduced error rates via digital tech transfer of Drug Substance/Drug Product/analytical methods and data.
- Enable creation, transformation, and storage of recipe master/reference data, transactional lab run data, DOE/batch execution data, and derived statistical/trending outputs.
- Standardize/structure process recipe data (CPPs/CCAs/In-Process Controls/operating ranges) with recipe version management.
- Develop CMC statistics assets and trending tools; enable CMC program management digitization and reporting.
- Create data products, templates, procedures, and seamless integrations (API/EDI) for process data exchange.
- Establish process data governance/stewardship and publish data products to support analytics/AI/ML.
- Own end-to-end lifecycle of CMC applications (strategy/design through deployment, sustainment, upgrades, continuous improvement, retirement); define business cases and manage TCO.
- Ensure GxP/data integrity/global regulatory compliance and audit readiness.
- Drive operational excellence for CMC systems (e.g., Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision).
- Lead and mentor cross-functional delivery; partner with stakeholders, IT, vendors, and procurement.
Qualifications:
Required:
- Bachelor’s degree in Science/Engineering/IT or related field.
- 10+ years in CMC, Process Engineering, or IT client-facing roles in biopharma/life sciences.
- Knowledge of regulatory filing, recipe unit operations/data structures; statistical software/trending tools (e.g., JMP, Minitab, R/Python, SIMCA, SEEQ).
- Strong stakeholder management/change leadership.
- Data and systems integration experience with IT suppliers/integrators.
- Regulated environment experience (GxP, computer systems validation, FDA 21 CFR).
- SDLC knowledge (requirements through decommissioning).
- Proven cross-functional team leadership; strategic + pragmatic delivery.
- Up to ~10% travel.
Preferred:
- Master’s/MBA/PhD.
- Working knowledge of EDI/APIs/data transfers and system integration.
- Agile/Scrum and Jira (or similar) experience.
- Familiarity with AI/data/digital capabilities (data models, lakehouse, knowledge graphs, agentic AI, LLMs).
Benefits (explicitly stated):
- Medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, and recharge breaks.
- Define and execute the IT solutions roadmap for CMC digital transformation.
- Oversee implementation and lifecycle management of digital CMC solutions to speed new pipeline products from Development Candidate through IND/NDA filings to commercial launch.
- Deliver digital and AI/ML capabilities for faster regulatory authoring and reduced error rates via digital tech transfer of Drug Substance/Drug Product/analytical methods and data.
- Enable creation, transformation, and storage of recipe master/reference data, transactional lab run data, DOE/batch execution data, and derived statistical/trending outputs.
- Standardize/structure process recipe data (CPPs/CCAs/In-Process Controls/operating ranges) with recipe version management.
- Develop CMC statistics assets and trending tools; enable CMC program management digitization and reporting.
- Create data products, templates, procedures, and seamless integrations (API/EDI) for process data exchange.
- Establish process data governance/stewardship and publish data products to support analytics/AI/ML.
- Own end-to-end lifecycle of CMC applications (strategy/design through deployment, sustainment, upgrades, continuous improvement, retirement); define business cases and manage TCO.
- Ensure GxP/data integrity/global regulatory compliance and audit readiness.
- Drive operational excellence for CMC systems (e.g., Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision).
- Lead and mentor cross-functional delivery; partner with stakeholders, IT, vendors, and procurement.
Qualifications:
Required:
- Bachelor’s degree in Science/Engineering/IT or related field.
- 10+ years in CMC, Process Engineering, or IT client-facing roles in biopharma/life sciences.
- Knowledge of regulatory filing, recipe unit operations/data structures; statistical software/trending tools (e.g., JMP, Minitab, R/Python, SIMCA, SEEQ).
- Strong stakeholder management/change leadership.
- Data and systems integration experience with IT suppliers/integrators.
- Regulated environment experience (GxP, computer systems validation, FDA 21 CFR).
- SDLC knowledge (requirements through decommissioning).
- Proven cross-functional team leadership; strategic + pragmatic delivery.
- Up to ~10% travel.
Preferred:
- Master’s/MBA/PhD.
- Working knowledge of EDI/APIs/data transfers and system integration.
- Agile/Scrum and Jira (or similar) experience.
- Familiarity with AI/data/digital capabilities (data models, lakehouse, knowledge graphs, agentic AI, LLMs).
Benefits (explicitly stated):
- Medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, and recharge breaks.