Michael Landau Email and Phone Number

Managing Director for Corden Pharma's operations in Colorado.

Supporting Pharmefex clients in transformation, organizational design, manufacturing strategy, capacity management, facility utilization, technical transfer, quality systems (change control, CAPA, deviation/non-conformance, etc.), supply chain management, program management, and audit preparation and remediation. With my extensive experience leading operations I excel at improving the relationship and maximizing efficiency between sponsor and service provider.

As a veteran leader in life science industry I am passionate about working with organizations to enable them and their partners to operate efficiently, enabling profitable growth for all stakeholders. Providing services to biopharmaceutical companies in the areas of cGMP manufacturing, corporate strategy, transformation, operational excellence, and management of external partners.

Operational leader of KBI’s global network, including six US and two European facilities. Responsible for KBI’s Process Development, Analytical Development, Manufacturing, IT, EHSS, and Supply Chain teams. Full P&L accountability for each of KBI’s business units; Microbial, Mammalian, Cell Therapy, and Analytics.• Executive sponsor for the transformation of KBI’s operations. Increased utilization of existing capacity across all modalities through organic growth resulting in $50M YoY revenue increase. • Championed quality culture improvement across operational teams for each business unit. Led global multidisciplinary team to improve quality performance by reducing batch disposition cycle time by >50% and decreasing deviations per batch by 25% for mammalian and microbial products to positively impact delivery of client programs.• Activated change across the organization while leading multiple major technology initiatives including; SAP, Planview (client portfolio management), and Manufacturing Execution System (MES) to revolutionize KBI’s digital infrastructure and improve employee productivity.• Restructured supply chain and procurement organizations to improve supplier relationship management and performance. Implemented consolidated demand planning, category management, and S&OP processes which increased asset utilization across KBI’s network of manufacturing facilities.

Accountable for KBI’s global operations team including Supply Chain and Procurement, Client Program Management, Engineering, and Operational Excellence. As a member of the Corporate Executive Team, transitioned the organization from a site based, functional reporting structure to a matrix organization. • On-time delivery of two new mammalian manufacturing facilities, one US based and one in Europe, in 24 months and on budget. • Directed the redesign of KBI’s client program management office to drive best practice sharing across company. Established specialized early and late stage teams to provide phase appropriate support for client programs. Aligned internal project team structure across all sites to streamline technical transfer process and drive value to KBI and clients.• Established new Global Operational Excellence Teams across KBI’s network resulting in identified opportunities to increase analytical lab throughput by 35% through improved operational efficiency.

Responsible for the KBI Biopharma commercial manufacturing portfolio. Led capacity management activities to ensure client supply forecasts were aligned with production capacity. Served as executive level contact with clients to manage program steering and ensure alignment for program life cycle strategy between organizations. • Lead negotiator for commercial supply agreements between KBI and late stage clients. • Collaborated with client leadership to identify post approval change prioritization and develop staged implementation approach.• Responsible for driving strategic partner initiatives with business development to diversify KBI’s product portfolio between clinical and late stage programs.

I had three positions with increasing responsibility as a member of the Site Leadership Team after KBI's acquisition of the Boulder Microbial Facility. Vice President, Manufacturing - June 2016 to December 2017In charge of microbial production operations, including manufacturing, supply chain, and technical operations departments. As the operational leader, responsible for managing end to end GMP supply chain for clinical and commercial programs. Led site through successful FDA pre-approval inspection, a first for KBI manufacturing services.Director, Manufacturing - February 2015 to May 2016As leader of microbial production operations for KBI, transitioned the organization to 24 x 7 multi-product facility. Increased staffing by 125% to accommodate business growth and support of product portfolio diversification efforts. Led department execution of right first manufacturing to achieve 100% success rate enabling department to exceeded revenue target, while meeting headcount and budget targets.Associate Director, Manufacturing - May 2014 to January 2015Managed manufacturing department, building the organization from four employees to fully staffed within two months. Served as change management leader to transition the site from a large pharmaceutical culture to an efficient, client focused CDMO business.

Providing expertise in the areas of cGMP equipment qualification, equipment validation, performance qualification.

Managed a team of technicians for the manufacture of microbial products. Lead process improvement teams to optimize Manufacturing and Quality systems.• Directed cross functional team in the redesign of standard operating procedures to implement error proofing and improve ease of use. Resulted in an increase of the right first time metrics and cost savings of ~$15,000 per month. • Facilitated kaizen events, 5S projects, and value stream mapping exercises to successfully improve process cycle time for manufacturing unit operations. • Managed the design, commissioning, and qualification of 2000L Stainless steel fermentor and 600L feed tank for large scale capital project.

Lead a team of manufacturing professionals in the production of biologic drug substance. Responsible for the end to end execution of the manufacturing lifecycle: Fermentation, Harvest, Solution Preparation, Liquid Chromatography, Ultrafiltration/Diafiltration (UF/DF), and bulk product filling.