Director, Manufacturing Platform Technology – Global Tech Ops

Job Title:

Director, Manufacturing Platform Technology – Global Tech Ops

Location:

Gaithersburg, MD

Hybrid working ~ 3 days per week in the office location

Are you ready to lead the charge in transforming AstraZeneca's manufacturing capabilities for 2030 and beyond? As the Director of Manufacturing Platform Technology, you'll be at the forefront of change, driving platform establishment across the enterprise!

The GTO Platform Lead represents a strategic cross-functional leadership role within Biologics Operations and Global Technical Operations. This position encompasses the leadership and development of a diverse, cross-functional team whilst maintaining primary accountability for strategic planning, coordination of technical leadership initiatives, and the provision of comprehensive operational support to our global technical network and key customer partnerships.

Join us in shaping the future of manufacturing technology and equipment platforms across biologics and new modalities!

Key Accountabilities
:

Lead a matrixed, cross-functional team to shape and scale AstraZeneca’s manufacturing technology/equipment platforms across biologics and new modalities. Partner closely with Development, Operations, Quality, Regulatory, and external manufacturers to deliver robust, flexible, and inspection-ready platforms.

Enterprise impact
:
Set the platform vision, standards, and roadmap; accelerate continuous manufacturing adoption; harmonize ways of working across internal sites and CMOs to improve speed, reliability, and cost to serve.

Platform strategy and standards
:

• Technology/Equipment Operating envelopes
  :
  Define highs/lows, critical process parameters, and control strategies for each unit operation.
• Templates and playbooks
  :
  Publish platform process descriptions, tech transfer playbooks, and manufacturing technology standards that teams can use globally.
• Change agility
  :
  Build comparability and “switch” strategies into equipment platforms to manage lifecycle changes with minimal disruption.

Modalities in scope
:

• Core
  :
  Fed-batch, intensified, microbial fermentation, and continuous mammalian bioprocessing
• Emerging
  :
  Nucleic acid therapies, Antibody drug conjugates, radio conjugates, viral and gene therapies, enzyme-produced biologics, protozoan fermentation

Continuous manufacturing leadership
:

• Vision and adoption
  :
  Set enterprise standards and the adoption plan for end-to-end continuous processing.
• Design and control
  :
  Define PAT/APC, residence-time distribution, steady-state verification, and start-up/shutdown strategies that meet global regulatory expectations.
• Scale-up and launch
  :
  Guide piloting through commercial implementation; quantify business value and embed learnings across the network.

Collaboration and matrix leadership
:

• Co-create with partners
  :
  Work hand-in-hand with CMC, Clinical, Regulatory, QA, and site leaders to align on risk, control, and lifecycle strategies.
• Network integration
  :
  Harmonize processes and capabilities across internal sites, CMOs, and acquisitions; establish clear governance, roles, and accountability.
• Transparent communication
  :
  Maintain timely updates, risk escalation, and portfolio alignment across Global Tech Ops and Biologics leadership.

Technology and site enablement
:

• Site readiness
  :
  Working closely with tech transfer leads, Stand up technology transfers to site, define ways of working, and embed digital tools for monitoring and decision-making.
• Technology Readiness: Acting along with current site leads, or in lieu of local MS&T for new sites,

Regulatory partnership
:

• Authoring and strategy
  :
  Co-author technical content for design control strategies that enable post-approval flexibility.
• Engagement and inspection
  :
  Prepare teams and sites for regulatory interactions and inspections.

Data-driven improvement
:

• Data and Process Standardization
  :
  Collaborating across the enterprise, establish standards for process data and information needed to support autonomous decision making.
• Performance management
  :
  Define metrics and scorecards; use feedback loops to track adoption and impact.

What Success Looks Like in This Role

Standardisation and Speed You will establish reusable platform standards…