Job Description
<b>Job Description Summary</b>The Manager, Process Experts, for Morris Plains Cell and Gene Therapy leads the team responsible for shop floor support and deviations, investigations and CAPA operating over multiple shifts 24/7/365. Specifically, the Manager, Process Experts, provides direction, leadership and guidance to Process Experts who support continuous improvement and technical support to cell processing operations.<br> <b>Job Description</b>365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role.<b>Major accountabilities: </b><b>People and Leadership</b><ul><li>Accountable for all aspects of staffing including recruiting talent, onboarding and training, performance management and strategic/succession planning for key roles</li><li>Ensures adequate resources and cross training to meet the demands of a multi-product cell processing operation</li><li>Maintains up to date job profiles for all team members</li><li>Develops and maintains individual development plans for direct reports</li><li>Champions a culture of Diversity & Inclusion, transparency, continuous improvement and recognition</li><li>Embeds Patient and Customer centricity into team culture</li><li>Provides visible leadership to all team members by providing coaching and support</li><li>Empowers team members to react appropriately to unplanned situations, driving decision making to the appropriate levels</li><li>Support teamwork, strong communication and motivation within and across teams</li><li>Supports the operations site strategy and ensure tactics are aligned with strategy</li></ul><b>Shop Floor Support</b><ul><li>Oversees front line technical support and procedural support to manufacturing</li><li>Oversee real time batch trending for improved Manufacturing Success Rate (MSR)</li><li>Deviations, Investigations and CAPA</li><li>Collaborates with Quality Assurance and provides oversight of deviation management to ensure timely and compliant closure</li><li>Establishing and reporting metrics and visual management tools for deviations, investigations and CAPA and reporting to Management for review and action</li></ul><b>Deviations, Investigations and CAPA</b><ul><li>Organizes and leads cross-functional investigation teams for critical and complex investigations, including owning escalations and external communications</li><li>Business Process & Improvements</li><li>Oversees process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx).</li><li>Provides updates to Site Management and Global Teams on critical deviations</li><li>Contributes to site financial & business goals</li><li>Maximize Quality and process improvements with a business owner mindset</li><li>Minimize rejected patient lots and material write-offs</li><li>Performs prioritization of core operations, continuous improvement projects in line with Morris Plains long term strategic plan</li></ul><b>Technology Transfer</b><ul><li>Provide timely support for process technology transfer activities from clients/3rd parties</li><li>Ensures knowledge transfer from MS&T into Process Expert Team</li></ul><b>Training</b><ul><li>Owns the training curriculum for PE and Sr PE and ensures effectiveness and compliance to training requirements</li><li>Owns the Investigator Certification Program (ICP)</li></ul><b>Audit Support / Client Support</b><ul><li>Act as SME during audits preparing data and presenting to health authorities and leading audit responses</li><li>Oversees strategy of audit responses and storyboards</li><li>Internal and external client management during investigations</li></ul>