/ Hiring

Device Development Project Manager II / Sr. Project Manager

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

• Partner with Device Team Leader to define and execute Device strategy in alignment with Technical Development (TDT) & Lifecycle Team (LCT)  strategies.  Develop realistic project plan/schedule and track Team’s progress in meeting milestones and deliverables.  Facilitate Device team meetings in partnership with Device Team Leader to drive sharing of information, decision-making, issues resolution , risk mitigation and team member engagement
• Ensure Device Team plan is integrated with Technical Development Team plan and aligns with overall LCT strategy
• Define and oversee the Device Team project milestones and key deliverables:
• Analyze & understand the critical path activities ensuring Team members are aware of interdependencies
• Drive flow of information across Team members and relevant key stakeholders to facilitate awareness of Team’s efforts and efficient decision-making
• Escalate unexpected events impacting project schedule, budget & resources to management
• Provide regular project updates to management on project status including risk mitigation plan.
• Monitor resource and project variable costs needed to execute Device Plan and work closely with TDT PM to ensure budget is integrated with TDT plan in PlanSource
• Support relevant design control activities outlined in standard and assist with drafting, compilation and tracking of Design Control Documentation as required.
• Support efforts business process improvement efforts including but not limited to updating business process content, implementing tools & best practices and driving awareness across Teams. 
• Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

Who You Are

• B.S. or B.A. degree (preferably in chemistry or biochemistry) and seven to ten years relevant business and/or technical experience in the medical device, pharmaceutical or biopharmaceutical industry preferably from a multi-site global company.  Advanced degree preferred.
• Qualified candidates must have a proven track record leading development projects and a strong technical knowledge of project management methodologies and design control requirements for device development.
• Expertise in the drug development process and demonstrated practical experience and knowledge of medical device development and commercialization.
• Ability to combine and integrate scientific background, drug & Device development knowledge, regulatory and compliance understanding to facilitate effective project management. Knowledge of relevant regulatory requirements (e.g. FDA & EU) applicable to various stages of drug development, including design control requirements for device development
• Demonstrated ability to work independently as a self-starter and to handle multiple priorities in a fast paced, ever-changing, team-based environment.
• Ability to communicate clearly and professionally both in writing and verbally.  Excellent written and verbal communication, listening, negotiation, presentation, organizational and management skills. Must be able to effectively communicate and align plans with external business partners. Demonstrate ability to effectively communicate in a highly matrixed organization. 
• Demonstrated proficiency with Microsoft Office software and specifically MS Project is required
• Project Management experience.  PMP certification a plus.
• Flexibility in problem solving, providing direction and work hours to meet business objectives.

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.