Contract Manufacturing Organization (CMO) Site Manager

Genentech•South San Francisco, CA

46d

About The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche! The Opportunity As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can produce material required by Roche's clinical trials seamlessly, on-time, and while optimizing cost/quality. Within Production Enablement the Global CMO Clinical Packaging Management team is responsible for overseeing the manufacturing outsourced portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers work closely with contract manufacturers (CMOs) worldwide, Clinical Planning, Quality and other operations functions to ensure product delivery from external manufacturing partners with optimal cost, quality and speed. CMO Site Managers also drive the evolution and implementation of new systems and efficient internal and external processes, in support of CMO production and the 2030 Pharma Vision: 3-5 times more benefit for patients at 50% less cost to society.

Requirements

5+ years experience in the pharma industry, supply chain management or in manufacturing
Experience with clinical drug manufacturing and or clinical supply chain strongly preferred
Proficient knowledge and experience of SAP or ERP system
BA/BS Degree, preferably in a technical, business or supply chain field.

Nice To Haves

Masters Degree a plus
APICS and/or SCOR certification, or equivalent relevant experience
PMP/Operational Excellence/Six Sigma/Lean training a plus
Solid understanding of the pharma industry, supply chain, contract manufacturing and/or clinical manufacturing activities
Demonstrated skills in project planning, project management and/or resource management
High degree of cultural awareness and social competence as required for successful internal/external cross-functional collaboration, communication and complex problem-solving with external partners from different cultures and countries
Strong analytical and problem solving skills, high attention to detail, and understanding of systems
Ability to communicate clearly and professionally both in writing, verbally, presentations, etc. (Excellent English skills - German basic skills beneficial)
Flexibility to start work as early at 7am (SSF employees), finish work as late as 6pm (Switzerland employees) and to work from 10am-Noon (Mississauga employees), as needed to meet needs of global environment

Responsibilities

Serve as a Contract Manufacturing Organization (CMO) Site Manager, organizing and overseeing the clinical drug labeling, packaging and device assembly production outsourced by Roche to a network of worldwide CMOs.
Proactively manage CMO project onboarding, communications, timelines, and delivery performance for outsourced clinical packaging orders to meet supply chain needs while ensuring cost and quality objectives are met
Perform post-production order management for clinical CMO Packaging orders in the ERP system
Partner with key stakeholders in the preparation for Requests for Proposal (RFPs) or Statements of Work (SOW), negotiate supply agreements and select vendors for outsourced clinical packaging.
Create and maintain Purchase Orders for CMO production in purchasing system.
Review and approve of CMO invoices.
Lead Supplier Relationship Management activities with CMO partners
Collaborate with internal cross-functional teams to understand needs/expectations for CMO offerings and performance.
Identify and champion internal and external process improvement opportunities and apply collaboration skills, technical principles and expert knowledge to drive solutions to a broad range supply chain issues.
Partner with CMOs to ensure capability and capacity to enable on-time and predictable delivery of outsourced clinical packaging production.
Represent CMO Clinical Packaging as SME and primary contact on key initiatives and projects..
Perform the tasks of the Production Enablement Lead and/or other PTDS Production Enablement functions, as required for optimal organizational success.