Biotech Manufacturing Associate Jobs in Poolesville, MD

The Associate Director, Digital & Business Process Strategy leads the vision, roadmap, and value delivery of digital products that span PASX, Tulip(MES), data historians, and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business Process Strategy team and partners with Operations, Quality, Global IT, Data & AI,Supply Chainand Site teams to modernize data flows, improveRightFirstTime, and enable compliant,datadrivendecision making from shop floor to enterprise.You will be based in Rockville, MD and report to the Senior Director of Digital & Business Process Strategy.

1. Product vision and roadmap

• Define and socialize a compelling product vision linkingMES (PASX, Tulip),Historian- CDZ, andLIMScapabilities to business outcomes (yield, cycle time, batch release, deviation reduction)

• Build and manage amultireleaseroadmap, balancing global platforms with site needs, technical debt, and regulatory priorities.

• Maintain a prioritized,valuerankedbacklog with clear acceptance criteria and Definition of Done.

2. Stakeholder and value management

• Act as the voice of Operations, Quality, and QA/QP in product decisions; translate pain points into epics/featuresto deliver e2e business processmaps andwell-definedbusiness requirements

• Quantify value through OKRs/KPIs (e.g., batch review time, exception rates, data availability SLAs) and track benefits realization.

3. Delivery leadership

• Lead agile squads (process SMEs, solution architects, data engineers,MESconfiguration, historians, LIMS specialists, validation) to deliver increments.

• Coordinate integration patterns betweenMES, historians, LIMS, ERP, data platforms, and analytics/AI products.

• Ensure robust data models, master data stewardship, and event/transaction standards supporting traceability across systems.

4. Compliance and validation

• Ensure productscomply withGxP,21 CFR Part 11/Annex 11, data integrity (ALCOA+), and site/enterprise validation requirements.

• Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit readiness.

5. Data and analytics enablement

• Enable contextualized data capture and lineage from equipment and MES to historian and LIMS; expose governed data to analytics platforms.

• Partner with Data & AI teams on use cases such asrealtimedeviation detection, golden batch, CPV/Continued Process Verification, andeBR/eBRRoptimization.

6. Operations readiness and lifecycle management

• Plan releases, cutovers, and change management across multiplesites;coordinate training and SOP updates.

• Own product performance, reliability, and cybersecurity posture; manage incidents, problem remediation, and continuous improvement.

• Manage vendor relationships (e.g., Korber,Factory Talk,PASX,Tulip, Historian and LIMS providers) and ensure contract deliverables align to roadmap.

• Bachelor's degree in engineering, life sciences, computer science, or related field; advanced degree preferred.

• 8+years in pharma/biotech or highly regulated manufacturing withhandsonexposure to at least two of the following:PASX (or equivalent MES),process data historians (e.g., PI/AVEVA, IP.21, Ignition),LIMS/ELN.

• 3+ years as a Product Owner or equivalent (product management, solution owner) delivering digital capabilities inGxPenvironments.

• Strong understanding of manufacturing and quality processes: recipe management,eBR, batch disposition, deviation/CAPA, CPV, stability, and sample lifecycle.

• Demonstrated experience integratingshopfloorsystems with enterprise platforms (ERP, QMS) and data/analytics stacks; familiarity with ISA95/ISA88 models and data standards.

• Practical knowledge of CSV/CSA, GAMP 5, data integrity, and audit expectations.

• Experience with PASX configuration and content management; knowledge of interface frameworks, EBR review workflows, and exception handling.

• Background in OT/IT convergence: OPC UA, MQTT, edge connectivity,timeseriesdata modeling, and event streaming.

• Working knowledge of modern data platforms and analytics (e.g., cloud data lakes,timeseriesservices, visualization, ML for manufacturing).

• Certification in Agile/Scrum (PSPO, CSPO) and/or product management; Lean Six Sigma or equivalent continuous improvement credentials.

• Experienceoperatingacrossmultisite/global manufacturing organizations and managing vendor ecosystems.

• Business valueorientationconverts operational challenges into measurable outcomes and prioritizes accordingly.

• Systemsthinkingunderstandsendtoenddata flows from equipment and MES to LIMS/quality and enterprise analytics.

• Stakeholder influence:buildsalignment across Operations, Quality, IT, and site leadership.

• Decision making under compliance:balancesspeed with validation and data integrity requirements.

• Communication and changeleadership;simplifies complex topics and drives adoption.

• Delivery excellence: strong backlog management, release planning, and risk mitigation.

The annual base pay for this position ranges from $122K to $184K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.