Main Purpose of the Position:
This position is part of Genentech's' Pharma Technical - individualized NeoAntigen Specific Therapy (iNeST) team based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer on a per patient basis. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of manufacturing equipment, processes, and the quality approach for this exciting and novel technology.
The position is responsible for the development, maintenance and advancement of the Enterprise Resource Planning (ERP) system master data used by iNeST. Successful candidates will represent the department as a subject matter expert and liaison between a variety of key internal and external stakeholders to maintain the integration between SAP other business and paper based systems. The successful candidate will be adept at leading cross-functional teams in problem identification and resolution and driving quantifiable business results. They will represent the department in interactions with the global business process management community and will proactively identify areas for improvement. They will be relied upon to work collaboratively and independently to solve emerging challenges inherent to project and system implementations. To this end, the successful candidate must also demonstrate competency and interest in broader aspects of Drug Substance and Drug Product, including; manufacturing, materials management, maintenance of equipment, master production and detailed scheduling, capacity management, and quality.
Be an expert on the Master Data business process. Lead and support the business process as required, including training others and supporting continuous improvement
Develop SAP Master data for load into system and evaluate impacts to other business systems
Support site readiness to plan and be ready for execution
Provide technical solutions to a variety of problems of varying scope and complexity
Coordinate and lead Data Strategy meetings with site and network representatives
Adhere to change management processes to ensure data is deployed and maintained in a controlled manner
Provide analysis and reporting of data to manage key performance indicators
Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests
Develop solutions that are imaginative, thorough, practical, and consistent with organization's objectives
Provide training on usage, enhancements and changes to business systems
Participates in developing courses of action that may impact multiple functions in the organization
Networks with senior internal and external personnel in own area of expertise. Represent organization on assigned projects.
Identify opportunities for improvement that may impact multiple functions in the organization
Leads cross-functional teams in the identification and implementation of improvement initiatives.
Qualifications / Requirements:
B.A. or B.S. degree with 5 years of work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master's Degree with 3-5 years of relevant experience, or an equivalent combination of education and experience.
Experience with ERP systems Recipe Development, Master Data and Detailed Scheduling
Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques
Possess strong analytical skills and understanding of systems and technical designs
Knowledge of cGMPs and equivalent regulations
Demonstrated ability to effectively interpret Quality standards for implementation
Demonstrated ability to manage small projects from initiation to delivery to achieve measurable results
Demonstrated ability to independently evaluate situations and propose potential solutions
Demonstrated ability to communicate clearly and professionally both in writing and verbally
Demonstrated ability to quickly learn a broad range of skills
Flexibility in problem solving and work hours to meet business objectives and dynamic production requirements
Demonstrated project management skills is preferred
APICS CPIM certification preferred
Experience with cell therapy manufacturing is preferred
Experience in personalized health care environment preferred