Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
Optimize the deployment of technical resources, manufacturing assets, and support functions across the network to maximize capacity utilization, process robustness, operational efficiency, and future growth capabilities.
Provide strategic leadership and technical oversight for complex investigations, change controls, risk assessments, and gap analyses across all manufacturing modalities, ensuring consistent execution and regulatory compliance throughout the organization.
Establish and govern standards for technical documentation, change management, technology transfers, and compliance-related activities supporting critical MSAT and NPI initiatives.
Lead technical and business assessments of new client opportunities to ensure strategic fit, technical feasibility, regulatory compliance, capacity alignment, and long-term profitability across the network.
Serve as the technical escalation point for major client engagements, regulatory inspections, and customer audits, providing expert guidance on complex manufacturing and process challenges.
Develop and sustain an integrated innovation and technology roadmap linking MSAT, NPI, Engineering, and Manufacturing to accelerate commercialization, improve process capability, and advance future manufacturing technologies.
Lead the cross-functional client technical intake and governance process, aligning commercial, technical, quality, and operational stakeholders to support successful project selection and execution.
Drive enterprise-wide change management initiatives, ensuring alignment and adoption across MSAT, NPI, Manufacturing, Engineering, Quality Assurance, Quality Control, and Supply Chain functions.
Act as the executive technical sponsor for strategic technology transfers, process performance improvements, lifecycle management initiatives, and network harmonization efforts.
Serve as a senior technical consultant and subject matter expert on complex operational, process, and client-related challenges across the organization.
Foster a culture of collaboration, technical excellence, innovation, and client focus while maintaining the highest standards of professionalism and compliance.
Represent the organization during client interactions, governance forums, technical reviews, and executive leadership discussions involving product transfers, manufacturing readiness, compliance strategy, and process improvement initiatives.
Develop and maintain strong collaborative relationships with internal stakeholders and external partners to ensure successful execution of technical and business objectives.
Ensure compliance with all applicable PCI policies, cGMP regulations, quality standards, and Environmental Health and Safety (EHS) requirements.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.
A frequent volume of work and deadlines may impose strain on a routine basis
Minimal physical effort is required
Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
Work Environment: The work environment characteristics described here…