Senior Project Manager

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The Position

We advance science so that we all have more time with the people we love.

Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

The Senior Project R&D Manager will plan and drive execution of cross functional projects with Product Development, Equipment Engineering, Product Maturity, Quality Assurance and other areas within the company. This individual will develop and document detailed technical work breakdown structures, sprints, project GANTT, resource plans, technical goals and budget, to deliver on project charters, business goals, and support delivery of superlative products for patients. This will be accomplished by interacting and providing effective leadership across cross-functional teams including Development, Engineering, Product Technical Support, Operations, Quality, and/or Regulatory.

• You will proactively identify and manage risks, critical path items, interdependencies, issues and delays, then work with team to develop risk mitigation and contingency plans to ensure projects remain on schedule and on budget; you will track and manage project and department FTE utilization and project consumable costs to budget. 

• You will manage Design History File, Device Master Record, Technical Study Reports, and Design Changes; you will set and manage meeting agendas, minutes and action items.

• You will create and manage “Virtual Team Room” and electronic experimental study (DOE) repository for cross functional effectiveness of a large team of professional scientists and engineers working across product development and operations; you will prepare effective slide presentations and present progress to goals per plan at regular updates.

• You will support management of projects that encompass: development in R&D, manufacturing process development, scale-up, process validation, test method validations, equipment IQ/OQ/PQ,  CAPAs

• You will manage projects under QMS for kits, reagents, consumables (test strip/cartridge), instrument.

• You will support R&D, Operations and Project Leadership in helping to implement change management. 

Education and Experience  

• You have a B.S. degree in the biochemical / life sciences or bioengineering with 13+ years of experience in life science product development, process development and engineering / automation  projects leading to product launches; you have Leadership executing, organizing, and influencing project teams in a matrix environment

• You have 8+ years of experience and demonstrated success as a Project Manager in an In Vitro Diagnostics company, resulting in Product Launch and Process or Design Enhancements and/or Process remediation in context of at least class II, 510k, CE-IVD products.

• You have experience managing projects under QMS for kits, reagents, consumables (test strip/cartridge), instrument products.

• You have demonstrated experience with Class II medical device product development, design controls,  ISO13485/cGMP; IVD and Point of Care / Disposable Consumable Assay Development experience 

• You have a demonstrated level of proficiency with Microsoft Office, Google Suite, MasterControl, SAP, Enterprise and project resource planning tools; you have experience developing detailed project plans using project management tools (SmartSheet, MS Project etc)

• You have demonstrated experience leading problem solving/root cause analysis 

Preferred:

• You are detail oriented and have demonstrated strong interpersonal skills

• You have strong organizational and presentation skills and ability to solve ambiguous situations. 

• You have the ability to work in a fast-paced, dynamic environment while juggling multiple projects

• You have the following certifications: Agile, Scrum, LeanSix Sigma and/or PMP