Client Lead, Synthetics DS Facility

AstraZeneca • Gaithersburg, MD

4d • Hybrid

About The Position

At AstraZeneca, we're united by a bold ambition: to push the boundaries of science and deliver life-changing medicines to patients worldwide. As a global, science-led biopharmaceutical company, we transform pioneering research into breakthrough treatments across oncology, cardiovascular, respiratory, and rare diseases. Here, your talent will contribute to innovations that truly matter—helping us reimagine healthcare and create a healthier future for all!
Are you ready to build a flagship synthetics drug substance facility that accelerates life-changing medicines to patients? A rare opportunity exists to lead the launch of a new facility on our Virginia campus. This campus will be built to support a rapidly growing pipeline in oncology, weight management, and metabolic disease. You will set the direction, shape how the facility operates, and ensure it delivers reliably and safely from day one.
As the Client Lead, you will define user requirements, align global partners, and operationalize the facility through start-up, product launch, regulatory approvals and into steady-state supply. You will be the leader who turns a blueprint into first batches and a sustainable, scalable operation—and position yourself to transition into the Site Lead role once the facility is running!

Requirements

• Proven expertise in pharmaceutical manufacturing, with good understanding of the specific requirements of synthetic DS manufacturing.
• Demonstrated experience defining user requirements and operationalizing new GMP facilities from design through start-up and new product introduction would be advantageous.
• Track record overseeing manufacturing execution, including production planning, scheduling and delivery to quality standards.
• Strong knowledge of safety, environmental and regulatory requirements in a GMP setting; proven ability to promote a strong safety culture.
• Experience driving continuous improvement using lean manufacturing principles and advanced bioprocessing techniques.
• Effective collaboration with site functions such as Engineering, MSAT, Supply Chain, HR, Finance and Quality, and with global functions including Capital Engineering, Global Tech Ops, PT&D, Quality, Finance, IT and Global Supply Chain.
• Experience implementing robust quality control measures and working in close partnership with Quality Assurance and Quality Control.
• Skilled stakeholder management, including engagement with senior leadership, project teams and external partners.
• Experience supporting budget and resource planning for complex programs.
• Proven risk identification and mitigation, with development of contingency plans for facility start-up.
• Ability to work within a matrix reporting structure and align across multiple global programs,
• US-based role with willingness to travel to Europe during facility design.

Nice To Haves

• Leadership experience in pharmaceutical operations from tech transfer through commercial supply.
• Hands-on leadership of greenfield or brownfield pharma facility start-ups.
• Familiarity with automation, digital manufacturing systems and data-driven performance management in GMP environments.
• Experience preparing for regulatory inspections and filings related to oncology products.
• History of recruiting, coaching and developing high-performing teams and future leaders.
• Collaboration with capital engineering programs and development organizations to accelerate start-up and scale-up.
• Demonstrated ability to transition from program leadership into site leadership roles.

Responsibilities

• Program Leadership: Define the facility’s user requirements and long-term vision; ensure delivery of a site that meets business needs for DS and supports the broader portfolio.
• Facility Readiness and Start-up: Lead the operationalization of the Virginia synthetics DS facility, including commissioning, qualification, and readiness for new product introduction and regulatory approvals.
• Global Alignment: Coordinate closely with related global workstreams, to ensure coordinated build, execution and collaborative learning.
• Safety and Compliance: Establish and reinforce a strong safety culture; ensure compliance with all relevant safety, environmental and regulatory requirements from design through routine operations.
• Manufacturing Execution: Oversee production planning, scheduling and execution to meet demand, achieve right-first-time performance and uphold rigorous quality standards.
• Team Development: Recruit, mentor and inspire a high-performing, diverse team; build capabilities that support safe, efficient and compliant synthetic operations.
• Process Optimization: Drive continuous improvement using lean principles and advanced bioprocessing techniques to boost productivity, reduce cost and enhance reliability.
• Quality and Inspection Readiness: Partner with Quality Assurance and Quality Control to implement robust quality controls and maintain inspection readiness throughout start-up and beyond.
• Stakeholder Engagement: Build trusted relationships with site functions, global partners, senior leadership and external partners to enable clear decisions and timely delivery.
• Budget and Resources: Support development of program budgets and resource plans; prioritize investments to achieve milestones and long-term value.
• Risk Management: Identify, assess and mitigate technical, schedule and operational risks; implement contingency plans to protect program timelines and supply commitments.

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed