Project Manager (Biomedical) - Exton, PA

dsm-firmenich•Exton, PA

16h•$90,000 - $115,000

About The Position

The Project Manager leads 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, and serves as the primary program interface between customers and internal functions. The Project Manager translates customer requirements into executable manufacturing plans and ensures commitments are delivered safely, compliantly, on time, and within approved financial parameters. The role coordinates cross-functional teams and external partners, oversees project financial performance and technical and operational readiness, and manages customer expectations, governance, changes, risks, and escalations. It also supports proposals and contract handoffs, leads project closeout and operational handoff, and contributes to project-management standards and continuous improvement.

Requirements

Bachelor’s degree in engineering, chemistry, materials science, biomedical engineering, pharmaceutical sciences, operations, or a related technical discipline.
At least 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.
Working knowledge of regulated manufacturing and quality-system concepts, including GMP, design or technology transfer, qualification and validation, change control, deviations, CAPA, risk management, and document control.
Strong proficiency in project scheduling, budget control, risk management, executive reporting, and collaboration tools.
Demonstrated ownership of project budgets, schedules, resources, risks, customer communications, and governance from initiation through commercial or operational handoff.
Demonstrated experience coordinating R&D, Process Technology, Manufacturing, Engineering, Quality, Regulatory, Supply Chain, Procurement, Commercial, and Finance functions.
Strong written and verbal customer communication skills, including facilitating governance meetings, negotiating priorities, and presenting to senior leadership.

Nice To Haves

Advanced technical degree or MBA.
Knowledge of specialty polymers, biomaterials, medical devices, pharmaceuticals, or contract manufacturing/CDMO business models.
PMP® certification or equivalent formal project-management credential; demonstrated application of predictive, agile, and hybrid delivery methods.
Experience with Microsoft Project or equivalent scheduling software, Excel-based financial tracking, Power BI, Teams, and SharePoint.
Experience leading customer-sponsored manufacturing, contract manufacturing, CDMO, specialty chemicals, biomaterials, medical device, pharmaceutical, or similarly regulated programs.
Experience with technology transfer, process scale-up, equipment commissioning and qualification, process validation, analytical readiness, and launch or ramp-up.
Documented record of recovering at-risk projects, managing scope changes, resolving cross-functional conflicts, and delivering measurable business outcomes.
Experience managing external suppliers, contractors, testing laboratories, or manufacturing partners.

Responsibilities

Lead customer manufacturing projects from feasibility and proposal support through initiation, technology transfer, development, scale-up, equipment readiness, qualification and validation, launch, and post-launch stabilization.
Create and maintain project charters, work breakdown structures, schedules, resource plans, budgets, cash-flow forecasts, risk registers, communication plans, and decision logs.
Establish project scope, deliverables, acceptance criteria, assumptions, dependencies, and change-control processes with customers and internal stakeholders.
Own project financial performance, including budget baselines, purchase commitments, capital and operating expenditures, forecasts, variance analysis, invoicing milestones, and escalation of margin or cash risks.
Coordinate 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 manufacturing and supply plans.
Facilitate governance meetings, stage-gate reviews, customer steering committees, technical reviews, and executive escalations; report on schedule, cost, quality, risks, decisions, and actions.
Manage dependencies involving raw-material qualification, supplier readiness, equipment procurement and readiness, installation, commissioning, qualification, analytical methods, batch documentation, training, and production scheduling.
Partner with Quality and Regulatory teams to ensure compliance with applicable quality systems, customer quality agreements, GMP requirements, change control, deviations, CAPA, validation, traceability, and document control.
Identify and quantify project risks using structured methods such as risk registers and FMEA; assign owners and define mitigation actions, contingency plans, and escalation thresholds.
Control scope changes and customer requests using documented impact assessments covering cost, schedule, resources, quality, validation, and commercial terms.
Build customer relationships, manage expectations, resolve conflicts, and document decisions, commitments, and approvals.
Support proposal development and contract handoff by validating assumptions, resource needs, timelines, capital requirements, deliverables, and milestone payment structures.
Lead project closeout, including deliverable acceptance, financial reconciliation, lessons learned, documentation archiving, handoff to routine operations, and benefit-realization tracking.
Contribute to PMO standards, templates, portfolio reviews, resource planning, and continuous improvement of project delivery.