Associate Director, CMC Technology Delivery

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 from Development Candidate (DC) through IND/NDA submissions to commercial launch.
- Drive digital and AI/ML capabilities to accelerate regulatory authoring, enable tech transfer (Drug Substance/Drug Product/analytical methods and data), and reduce errors.
- Enable creation, transformation, and storage of process recipe master/reference data; transactional lab run data; DOE and batch execution data; and derived data via statistical models/trending outputs.
- Structure and standardize process recipe data for CPPs, CQAs, In-Process Control parameters, NOR/PAR ranges, and recipe version management.
- Develop CMC statistics data assets and lifecycle-managed trending tools; support CMC control strategy and process/product control.
- Enable CMC program management capabilities (R&D-to-CMC transfer, start-up, advancement, status reporting).
- Partner to create data products, templates, procedures, and API/EDI integrations with CMOs and IT partners for process data exchange.
- Proliferate user adoption of digital/statistical analytics across use cases from trending to regulatory filings and commercial manufacturing support.
- Establish process data governance/stewardship and data products on the enterprise platform.
- Own end-to-end lifecycle accountability for CMC applications; define business cases/outcomes and manage total cost of ownership.
- Ensure GxP, data integrity, and global regulatory compliance; maintain audit readiness.
- Ensure reliability, performance, compliance, and high-quality support for systems (e.g., Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision).
- Lead and mentor cross-functional teams; deliver initiatives and manage partnerships with stakeholders, IT teams, vendors, and procurement.

Qualifications:
Required
- Bachelor’s degree in Science, Engineering, IT, or related field.
- 10+ years’ experience in CMC, Process Engineering, or IT client-facing roles in biopharma/life sciences.
- Experience with regulatory filing processes; recipe unit operations/data structures; statistical software and analytical trending tools (e.g., JMP, Minitab, R, Python, SEEQ, etc.).
- Strong stakeholder management/change leadership.
- Experience in data and systems integration/analytics; working with system integrators and IT suppliers.
- Regulated environment experience (GxP, computer systems validation, FDA 21 CFR).
- Knowledge of full SDLC.
- Proven success building/leading cross-functional teams; strategic but pragmatic delivery.
- Ability to travel ~10%.
Preferred
- Master’s/MBA/PhD.
- Knowledge of EDI, APIs, system integration, and data transfers.
- Agile/Scrum experience (e.g., Jira) and project management best practices.
- Familiarity with emerging AI/data capabilities (e.g., data models, lakehouse architecture, knowledge graphs, agentic AI, LLMs).