Executive Director, Automation, Robotics, and Technical Writing – Cell Therapy, Process Sciences, Analytics and Technology

AstraZeneca•Santa Monica, CA

1d•$255,000 - $380,000•Hybrid

About The Position

The Executive Director, Automation, Robotics, and Technical Writing – Cell Therapy, Process Sciences, Analytics and Technology reports into the Vice President, Process Sciences and Analytics and Technology in the Cell Therapy business unit. The position will set the vision, strategy, and execution for automation, robotics, digital integration, and technical writing across Process Sciences, Analytics and Technology. This leader owns the multi‑year capability build—spanning automated and closed‑system laboratory/pilot operations, end‑to‑end data connectivity, process control, and a best‑in‑class technical writing function that accelerates development and underpins robust technology transfer and regulatory success. The role partners with Process/Analytical Development, MSAT, Manufacturing, Quality, Digital/IT, Supply Chain, and Regulatory to drive portfolio impact, shorten cycle times, and enable reliable scale‑up from preclinical through commercial readiness.

Requirements

Advanced degree in engineering (chemical, biomedical, electrical), computer science, or related field; PhD preferred or MS with substantial industry experience.
12–15+ years in biopharma/biotech with 7+ years leading automation/robotics and digital connectivity programs; direct experience in cell therapy or ATMPs strongly preferred; leadership across multi‑site/global organizations.
Proven delivery of automated and closed‑system cell processing and lab robotics; deep familiarity with ELN/LIMS, MES/eBR, SCADA/DCS, historians, data lakes, and integration patterns; experience with single‑use technologies, aseptic/BSL‑2, and cleanroom constraints; understanding of AI/ML for process development is a plus.
Strong grounding in GxP, data integrity, and CSV; experience supporting IND/BLA modules, pre‑approval inspections, and inspection readiness.
Evidence of building or leading a technical writing function; mastery in authoring and reviewing complex development reports, protocols, comparability, and tech transfer packages with clear traceability and scientific narrative.
Track record of building high‑performing teams, setting strategy, securing investment, and influencing senior stakeholders across Development, MSAT, Manufacturing, Quality, and Digital/IT; adapt at change management and user adoption.
Ability to quantify ROI, define KPIs, and make trade‑offs across cost, speed, and risk; skilled in vendor negotiations and long‑term agreements.
Exceptional communication, stakeholder management, and executive presence; structured problem solving and prioritization in fast‑paced, ambiguous environments.

Nice To Haves

PhD preferred or MS with substantial industry experience.
Direct experience in cell therapy or ATMPs strongly preferred.
Understanding of AI/ML for process development is a plus.

Responsibilities

Define the multi‑year strategy and target operating model for automation, robotics, digital connectivity, and technical writing; align with platform and modality roadmaps.
Establish and lead an integrated organization of automation/controls engineers, robotics specialists, data/OT engineers, integration architects, and technical writers; set governance, prioritization, and ensure project finance targets
Oversee selection and deployment of closed and semi‑closed automated unit operations, robotics implementation and automated solution for QC analytics.
Architect and deliver secure, validated connectivity from bench and pilot instruments to enterprise platforms, including: System Integrations: Integrate instruments and controllers with ELN/LIMS, MES/eBR, SCADA/DCS, data historians, and data lake/warehouse; implement event‑driven and API‑based data flows with robust error handling and retries.
Define standard data models, ontologies, and metadata schemas for cell therapy unit operations; enforce FAIR principles and contextualization to enable analytics, modeling, and seamless tech transfer.
Partner with IT/Cyber to implement role‑based access control, certificate management, secure patching, and vulnerability management across OT assets.
Deliver CSV for integrations and interfaces; ensure audit trails, electronic signatures, and data integrity (ALCOA+) are designed in and tested; maintain change control for connectors and adapters.
Stand up observability (logging, metrics, alerting), connection health dashboards, and SLAs for data latency and uptime; establish support models and incident response for OT/IT integrations.
Technical Writing Center of Excellence: Build a COE delivering high‑quality protocols, reports, comparability packages, work instructions, and CMC‑supporting content; standardize templates and review workflows to reduce cycle time and improve traceability.
Compliance and CSV: Ensure GxP alignment, data integrity, and CSV for automated systems and digital interfaces; define SOPs, training, and inspection readiness; incorporate cybersecurity and business continuity requirements into design.
Sequence and resource programs that reduce manual touch points, increase throughput, and enhance data reliability; track realized benefits to cycle time, cost of goods, and quality.
Talent and Culture: Recruit and develop a multidisciplinary team; foster a culture of safety, scientific rigor, design‑for‑GMP, and continuous improvement; lead change management and user adoption for new automated and connected workflows.
Cross‑Functional Influence: Serve as primary interface with PD leadership, MSAT, Manufacturing Operations, Quality, Digital/IT, and Regulatory; represent the function in governance forums and relevant regulatory interactions.