Participates throughout the Design Control process on new product project teams as a member of the extended Life Cycle Team representing Operations. Communicates project team issues, needs and status to Operations management, and communicates Operations input and deliverables status to assigned project team.
Creates detailed project timelines for Operations related activities and manages development transfer project activities required to meet published launch timelines for new products. Is responsible for coordinating production and ensuring delivery of reagents to meet Development needs.
Identifies potential bottlenecks or problem areas in the established timelines. Creates solutions and actions plans to help ensure that problems are resolved and projects remain on schedule. Seeks guidance, as necessary and appropriate, to determine best course of action to ensure that problems are resolved and projects remain on schedule. Establishes timelines and schedules, in coordination with the project team, for complex projects.
Leads cross functional project sub-team. Convenes periodic project meetings, issues meeting agendas, leads discussion regarding project status, and provides minutes that summarize key discussions and actions.
Coordinates and prepares Operations documentation for project milestone reviews in support of Design Control requirements. Prepares documents for Post Launch Reviews of assigned products.
Executes Global Operations Design Transfer standard work, including driving Operations design transfer standard process with clearly defined roles and responsibilities, utilizing tools and templates and leading the project communication strategy. Identifies continuous improvement of standard work elements. Education :
Bachelor's degree in Business Administration, Science or related field, or equivalent combination of education and work-related experience, required.
PMI Certification, preferred.
5 – 7 years relevant experience in the pharmaceutical or biotechnology industry with at least 3 years of project management responsibilities, required.
Experience effectively managing large and complex projects and leading cross-functional teams.
Must have strong verbal and written communication skills with the ability to plan, organize and motivate people.
Good understanding of the product development and / or launch process.
Roche - 17 months ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...