Associate Director, Program Management

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Houston's Program Management team is looking for an Associate Director, of Program Management to support our growing business, clients, and development of the PM team.

POSITION:                 Associate Director, Program Management

JOB LOCATION:      14905 Kirby Dr. Houston, TX 77047 [and various unanticipated locations throughout the U.S.; may work from home]

Associate Director, Program Management needed by Lonza Houston, Inc. in Houston, TX [and various unanticipated locations throughout the U.S.; may work from home] to implement project management principles and precise timelines tracking across a span of areas and deliverables including, analytical methods, process development, Non-Good Manufacturing Practice (GMP) and GMP manufacture, and IND submission and commercialization. Integrate all aspects of Quality (QA/QC) regulatory, GMP manufacturing readiness, MSAT, Bio-assay services, validation, facility compliance, process, and operational controls into project governance. Develop and obtain approval of FDA and international regulatory compliance, CMC project plans, risk management and communication plan; and understand and apply advanced principles of molecular biology, gene therapy, cGMP operations, drug substance/product manufacturing, filling, packaging, bio-analytical method development, and qualifications into managing the program. Lead and drive program management through full conceptual understanding of principles of HPLC, potency, ELISA, chromatographic purification, drug potency, and PCR (ddPCR, QPCR) at Lonza and at contract testing labs. Coordinate cell /virus bank (RCB, MCB, WCB) development, qualification, and release for cGMP use. Work with cross-functional stakeholders and customers to define, organize, execute, monitor, and close out critical activities such as approvable bill of materials (BOM), product specification, QC sampling and testing plan, batch record reviews, analytical method reviews, generation of stability plans and reports, product investigation, and CAPA summaries. Manage critical processes such as New Product Introduction change controls, batch releases, domestic and international product shipments for clinical use, client visits, audits, etc. Use all PM standard work processes to effectively manage projects. Oversee operational aspects in leading and motivating cross-functional project teams to deliver on all scope objectives with the highest level of quality. Perform and manage execution of contracts change orders, schedule and budget variance management, and progress reporting to stakeholders. Maintain high standard of communication with the customer and Lonza by establishing communication plans, escalation pathways, governance committees stakeholder, and RACI matrix. Organize conduct project kick-off meetings for in-person and virtual meetings with the highest standard of communication. Conduct periodic lessons with the customer to ensure customer satisfaction and collaborative improvements throughout the program lifecycle. Manage program financials such as forecasting, invoicing, and revenue recognition. Monitor PC2 including cost, and revenue financial conflict resolutions with the customer. Ensure completion of deliverables on-time and in full (OTIF). Work with internal and external cross-functional teams and upper management. Maintain project risk assessment and risk mitigation plans, project charter, communication plan, RACI matrix, various trackers, timelines, and Gantt charts. Maintain and manage agendas, meeting minutes, action items, and risk registry. Apply knowledge in a cGMP environment following CFR quality and regulatory guidelines. Implement product development, cGMP manufacturing, and Chemistry Manufacturing and Controls (CMC). Utilize MS Office Suite, SAP, and PM software such as Planview, Smartsheets, Asana, and MS Project. Utlize PowerBI tools, SAP, MS Teams, and SharePoint. Oversee all project communication, milestones agreements, and conduct exercises. Decommission projects at the end of contractual activities. Prepare amendments and/or scope changes. Partner with the sales/commercial development team. Provide input into mid and long-term program strategies, executing program relevant section of the sales, and operations process. Manage program budget, invoicing, and revenue recognitions. Work with protein expression and purification, biochemistry, and molecular biology. 

MINIMUM REQUIREMENTS: Require