Associate Director, CMC Technology Delivery

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) match

Paid time off and wellness days

Job summary

Scorpion Therapeutics in Cambridge, MA is seeking an experienced professional to define and execute the IT solutions roadmap for their digital transformation in CMC. This role involves overseeing the implementation of digital solutions and ensuring compliance with regulatory standards.

The ideal candidate will have over 10 years of experience in CMC, strong leadership skills, and a background in data and systems integration. Scorpion Therapeutics offers a comprehensive benefits package including medical, dental, and a 401(k) match.

Qualifications

• 10+ years in CMC, Process Engineering, or IT client-facing roles.
• Regulated environment experience (GxP, computer systems validation).
• Proven cross-functional team leadership.

Responsibilities

• Define and execute the IT solutions roadmap for digital transformation.
• Oversee lifecycle management of digital CMC solutions.
• Drive operational excellence for CMC systems.

Skills

CMC, Process Engineering, or IT experience

Regulatory filing knowledge

Stakeholder management

Data and systems integration

Statistical software proficiency

Education

Bachelor’s degree in Science/Engineering/IT or related field

Tools

JMP

Minitab

R/Python

Job description

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.