Christopher Schell Email & Phone Number

New Jersey, United States

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 successful implementation.• 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 monitoring to sustain long-term benefits.• 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 collaborative and proactive approach to change.• 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 across all levels of the organization.• 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 staffed.• Supports the Kenvue Chief Quality Officer: Provided expert support and content development for initiatives falling under the scope of change management, collaborating closely with the Kenvue Chief Quality Officer to align change efforts with overall quality goals and strategies.

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 transformation projects to drive improvements in overall productivity, compliance, quality, and patient safety. Lead the strategic planning process to define the vision and objectives of senior management endorsed projects.Cultivate connectivity and alignment between people, teams, and data sources to enable delivery of cross-functional projects.

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 integration.)• 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. • Serves as a key point of contact for R&D, Quality, Commercial and other key Consumer sector functions, and Enterprise stakeholders for Self-Care medical safety matters related to the PV system.• Partner with SST Leads and counterpart DSL, and Safety Strategy Realization to align safety related activities through common processes, systems, and practices.

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.• Ensures safety data is adequately collected and reported through developing strong collaborative relationships with Local Safety officers and program leads.• Provides frequent project status metrics/updates and inclusive summaries to key stakeholders, program directors, and senior management.

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.• Direct contact for support of LM-biologic production testing and QC/QA decisions regarding compliance of batches with established specifications.• Analyzed statistical data for trending and reporting; identifying trends appropriately to gain real time insight on outliers that occurred within a controlled process. Organized and presented all trends to effectively communicated associated metrics and escalation when required. • Developed business cases for capital projects associated with QC laboratories, strategically prioritizing ONE lab initiatives, new technology, and New Product Implementation. Provided Leadership and insight to the Global Project Teams.

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• Developed and Managed the Retain Management Program.• Coaches contract partners, participates in talent recruitment, and plans all laboratory continuous improvement projects.• Manages the institution of all major pharmaceutical compendia changes and associated training.

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 qualification.• Coordinated multiple ongoing validation projects. Daily progress reporting, various department personnel coordination for timely installations, equipment servicing, and vendor qualification.• Designed and implemented the Analytical Laboratory layout in accordance with workflow, functionality, and safety.• Led the operation and organization of the lab system validations and upgrades, including SAP master data system, Empower 3 • Lead for all Analytical Engineering Change Controls.

• 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.• Tested for release of WFI, raw materials, components and finished products by performing testing per current USP/EP.• Lead for Oxygen testing of parenteral samples.• Performed monthly and daily maintenance of laboratory equipment (HPLC, GC, UV-VIS, Balances, etc.)• Evaluated results and investigated any out of specification results.

Master'S Degree, Clinical Trial Organization & Mgt.

Bachelor Of Science - Bs, Biochemistry