Life Sciences Manufacturing Transformation Lead (AI & Ops)

EY; Baltimore (MD); Remote; USD 128,000 - 257,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Job summary

EY is seeking a Life Sciences Manufacturing Manager to lead technology-enabled transformation workstreams across pharmaceutical, biotech, and medical-device clients. The role combines plant-floor manufacturing insight with digital, data, AI, and delivery expertise to deliver compliant, high-performing solutions.

You will coordinate across MES/MOM, ERP, LIMS, QMS, and OT/IT interfaces, drive requirements, and oversee implementation, testing, and adoption while partnering with senior engagement

Qualifications

• Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, or related discipline.
• At least 7 years of relevant Life Sciences manufacturing, manufacturing technology, or related experience.
• Experience leading a client-facing manufacturing, digital, data, or technology workstream through design and at least one implementation or deployment phase.
• Experience working in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.

Responsibilities

• Lead client-facing workstreams in Life Sciences manufacturing transformation with ownership of plans, deliverables, risks, decisions, and outcomes.
• Assess current-state production and quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops, data analysis, and plant engagement.
• Translate priorities such as yield, throughput, right-first-time execution, batch-cycle time, deviation reduction, asset reliability, and supply continuity into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for capabilities like batch execution, electronic batch records, recipe management, genealogy, review by exception, connected-worker workflows, maintenance, and performance management.
• Coordinate integration requirements across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, asset-management systems, and cloud or edge platforms with architecture, automation, and cybersecurity specialists.
• Define and review data mappings, asset and batch context, master-data needs, interface specifications, and data-quality controls for reporting, analytics, and AI use cases.
• Help deliver analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, and human oversight.
• Work with client quality and validation teams to reflect applicable GxP, data-integrity, electronic-record, change-control, and validation or risk-based assurance requirements in workstream deliverables.
• Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover for your workstream.
• Facilitate working sessions across manufacturing, quality, MS&T, engineering, supply chain, IT, OT, data, and technology-vendor teams; manage dependencies affecting the broader program.
• Manage workstream scope, schedule, resources, quality, and risks; provide status updates and contribute to estimates, proposals, and follow-on opportunities.

Job description

EY is seeking a Life Sciences Manufacturing Manager to lead technology-enabled transformation workstreams across pharmaceutical, biotech, and medical-device clients. The role combines plant-floor manufacturing insight with digital, data, AI, and delivery expertise to deliver compliant, high-performing solutions.

You will coordinate across MES/MOM, ERP, LIMS, QMS, and OT/IT interfaces, drive requirements, and oversee implementation, testing, and adoption while partnering with senior engagement