Christopher Schell Email & Phone Number

New Jersey, United States

Skillman, New Jersey, US

• Conducts Comprehensive Change Management Assessments: Evaluated current awareness and readiness for change, identified key areas of resistance, and developed strategies to address and mitigate these challenges.
• Develops and Implemented Risk Mitigation Tactics: Identified potential risks associated with change initiatives, conducted thorough risk analyses, and prepared detailed risk mitigation plans to ensure smooth and.
• Manages Change Adoption and Reinforcement: Led the identification and management of adoption strategies, ensured effective usage of new processes and systems, and reinforced change through ongoing support and.
• Provides Strategic Leadership and Direction: Guided the QHS Change Management Team, QHS Change Agent Team, and Strategy & Change Specialist in the execution of change management strategies and plans, fostering a.
• Prepares and Supports Senior Leaders: Equipped senior leaders and people leaders with the necessary tools, training, and support to effectively communicate and implement change strategies, ensuring alignment and buy-in.
• Allocates Budgets and Managed Resources Efficiently: Oversaw the allocation of budgets and managed resources to optimize the use of financial and human capital, ensuring that change initiatives were well-funded and.

Skillman, New Jersey, US

New Brunswick, NJ, US

Navigate and lead the transition and development of a new PV safety system to support New Company vision while maintaining compliance and functionality.Develop and implement new process and/or optimize existing process to maximize business values ( Real World Data Project)Lead high priority cross-functional process excellence, innovation, and business.

New Brunswick, NJ, US

• Leads multiple projects of varying complexity and high business impact (e.g., company integrations, CAPA remediation workstreams, Process Design).
• Establishes project teams and guides activities to meet project and business objectives, requirements, and approval of project recommendations through governance.
• Drives team accountability for deliverables and ensures project milestones are met.
• Leads high priority cross-functional process excellence, innovation, and business transformation projects to drive improvements in overall productivity (e.g., lean principles, project real world, and Zarbee’s.
• Drives consistent and continuous improvement in process and personnel development across stronghold, assisting in key priority execution and enabling a high performing team.
• Proactively manages Safety Stronghold Operations in a cross-functional safety team, ensuring accountability and risk management, inclusive of communication to senior leadership.

New Brunswick, NJ, US

• Provides strategic support and guidanceto key stakeholders throughout the lifecycle of market research, patient support, and real-world evidence studies.
• Manages and maintains project scheduling for all MR, PSP, and CS (what are these?), including adherence to activity milestones and key deliverable dates.
• Proactively guides regional activity owners by identifying potential risks and issues and supplying optimal mitigation efforts.
• Collaborates with IPV and Market Research organizations to streamline systems and processes; ensures that safety data management training is complete.
• Leads technology-related and continuous improvement projects such as the ICD contract automation initiative.
• Provides support and input to shape and drive pharmacovigilance operational and tactical audit plans continuously improving the efficiency and sustainability of the audit program.

Raritan, New Jersey, US

• Business Support of CAPA commitments assigned to QC; ensured robust and inspection ready CAPAs, metrics and dashboards, CAPA Escalation and tracking for site management.
• Led cross-functional teams through inspection readiness activities, inspection response, and execution of post inspection CAPAs.
• Served as SME for all NPI products, including successful CAR-T launch as Supervisor of the In-Process Laboratory (IPL) and Microbiology Laboratory.
• Established and developed strong cross-functionally trained talent pipeline to support all models of growth and capable in supporting faster forward initiatives.
• Successfully designed and directed the validation of site and employees for aseptic processing in support CAR-T facilities start up.
• Developed and executed the QC Laboratories inspection readiness program and served as a subject matter expert in inspection readiness.

New Brunswick, NJ, US

• Coordinated all Enterprise Lab System and Technology projects for the Analytical Laboratories.
• Lead Coordinator for Investigations, Data review, APR contributions, SOP updates, training, and change controls in the Analytical Laboratory.
• Responsible for the complete oversight of the Marketed Product Stability Program (MPS) including preparation of the Annual Plan, stability reports, and protocols.
• Designed and lead project execution programs and teams for instrument and computer system Validation work streams for the QC Analytical and Microbiology laboratories.
• Designed and managed the Analytical Metrology Program.
• Led cross-functional teams through inspection readiness activities, inspection response, and execution of post inspection CAPAs

US

• Successfully defended all validation efforts of the QC Analytical Laboratories to the FDA and Quantic under Consent Decree.
• Managed the development and implementation of project plans to bring QC Analytical labs to full capacity in support of Tech Transfer activities.
• Developed and implemented calibration and preventative maintenance requirements/procedures for all existing and new instruments and equipment in the Analytical Laboratory across three sites.
• Developed and led the Analytical Laboratory Metrology program.
• Interfaced across various areas of the business including but not limited to QA Operations, QA Validation, IT, Metrology, and Quantic Group to execute computer systems validation activities and instrument/equipment.
• Coordinated multiple ongoing validation projects. Daily progress reporting, various department personnel coordination for timely installations, equipment servicing, and vendor qualification.

• Lead Scientist responsible for cleaning validation and bulk testing in a sterile environment.
• Lead for component testing of sterile pharmaceutical packaging configurations.
• Reference standard coordinator. Developed and maintained a narcotic inventory system for DEA inspection and successful re-certification.
• Adhered to SOPs regarding proper chain-of -custody for narcotic laboratory inventory.
• HIAC Senior Particulate Matter Analyst. Provided training for other analyst in addition to reviewing all data and documentation for component and product releases.
• Authored Investigations, Laboratory Events, Protocols and other documentation as required.

Master'S Degree, Clinical Trial Organization & Mgt.

Bachelor Of Science - Bs, Biochemistry