Project Manager (Biomedical) - Exton, PA

Project Manager (Biomedical)
Exton, PA
The Project Manager is responsible for leading customer-sponsored manufacturing programs from opportunity assessment and contract handoff through technology transfer, process development, scale-up, validation, commercial launch, and lifecycle management. The role is accountable for integrated scope, schedule, budget, quality, risk, and stakeholder management across multiple concurrent programs. The position serves as the primary program interface between customers and internal functions, translating customer requirements into executable manufacturing plans and ensuring commitments are delivered safely, compliantly, on time, and within approved financial parameters.
Key Resonsibilities:
Lead the end-to-end lifecycle of customer manufacturing projects, including feasibility, proposal support, project initiation, technology transfer, development, scale-up, equipment readiness, qualification/validation, launch, and post-launch stabilization.
Create and maintain the integrated project charter, work breakdown structure, schedule, resource plan, budget, cash-flow forecast, risk register, communication plan, and decision log.
Establish scope, deliverables, acceptance criteria, assumptions, dependencies, and change-control mechanisms with the customer and internal stakeholders.
Own project financial performance, including budget baseline, purchase commitments, capital and operating expenditures, monthly forecast, variance analysis, invoicing milestones, and escalation of margin or cash risks.
Coordinate cross-functional execution across Commercial, R&D, Process Technology, Manufacturing, Engineering, Quality, Regulatory, Supply Chain, Procurement, Finance, EHS, and external partners.
Translate customer demand, specifications, quality requirements, and launch targets into an executable manufacturing and supply plan.
Facilitate governance meetings, stage-gate reviews, customer steering committees, technical reviews, and executive escalations; issue concise status reports covering schedule, cost, quality, risks, decisions, and actions.
Manage technical and operational dependencies such as raw-material qualification, supplier readiness, equipment procurement, installation, commissioning, qualification, analytical method readiness, batch documentation, training, and production scheduling.
Partner with Quality and Regulatory teams to ensure compliance with the applicable quality system, customer quality agreements, GMP requirements, change control, deviations, CAPA, validation, traceability, and document-control expectations.
Proactively identify and quantify project risks using structured methods such as risk registers and FMEA; define owners, mitigation actions, contingency plans, and escalation thresholds.
Control scope changes and customer requests through documented impact assessments covering cost, schedule, resources, quality, validation, and commercial terms before implementation.
Build productive customer relationships, manage expectations, resolve conflicts, and ensure that decisions, commitments, and approvals are documented.
Support proposal development and contract handoff by validating project assumptions, resource needs, timelines, capital requirements, deliverables, and milestone payment structure.
Lead project closeout, including final deliverable acceptance, financial reconciliation, lessons learned, documentation archive, handoff to routine operations, and benefit realization tracking.
Contribute to PMO standards, templates, portfolio reviews, resource planning, and continuous improvement of SBM project delivery.
We Bring:
The opportunity to help shape the future of consumer discovery, AI-powered commerce, and digital engagement.
Meaningful ownership and visibility within a collaborative, entrepreneurial environment.
The chance to work on trusted consumer health brands that positively impact millions of consumers.
Growth that keeps up with you through continuous learning, experimentation, and career development opportunities.
A culture that lifts you up through collaboration, curiosity, and shared success.
The opportunity to work at the intersection of technology, marketing, consumer insights, and innovation.
You Bring:
Bachelor’s degree in engineering, chemistry, materials science, biomedical engineering, pharmaceutical sciences, operations, or a related technical discipline required; advanced technical degree or MBA preferred.
Minimum 5 years of relevant professional experience, including at least 3 years leading complex, cross-functional technical, manufacturing, capital, new-product-introduction, or customer-delivery projects.

Skills
Procurement, Documentation

Experience
3+ yrs