*This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech

Target Hire: March 1st

• Device and Packaging Development designs, develops, scales, transfers, and supports manufacturing of combination product drug delivery devices for Genentech (Roche) to enable safe, effective, and convenient administering therapies. Examples of combination products include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components.
• Device and Packaging Development’s project management office connects people, processes, and systems to enable compliant and agile team execution and deliver novel technologies & medicines to patients by delivering high-value project management core competencies to achieve results. The project manager is an integral part of a multifunctional project team, including device engineering, pharmaceutical development, regulatory, clinical, and quality as well as representatives from across our global network and supply chain. 

Expectations:

• Deliver high value project management core competencies and best practices with high-performing cross-functional teams to achieve technical development milestones on-time, on-budget and with high quality.

Duties:

• Manage technical product development teams and projects of moderate to high complexity (e.g. cross functional, multi site, global) with a results oriented mindset.
• Develop realistic, integrated project plan/schedules with multiple scenarios and drive development team progress toward deliverables and milestones, including analysis critical path activities and mitigate interdependencies and risks. 
• Ensure project deliverables are integrated with the overall Technical Development Team program, in alignment Lifecycle Team Target Product Profile strategy.
• Apply knowledge of design controls and risk management to create appropriate phase-based approaches that comply with applicable Quality System Requirements
• Partner with Device Team on design control strategy, execution and change management, authoring documentation and facilitating design reviews to ensure a complete and compliant Design History file.  
• Facilitate and drive project and technical collaboration with internal and external partners including suppliers, contract development and manufacturing organizations and test labs.
• Partner closely with Device Team Leader in scenario planning and defining and executing the device/technology strategy.
• Facilitate efficient decision-making, issue resolution and risk mitigation 
• Manage and facilitate effective team meetings, communications and interactions as well as engaging and collaborating with key stakeholders and governance.
• Foster a high performing, inclusive and collaborative team environment, monitor team dynamics and facilitate team building.  
• Estimate, negotiate and plan the resources needed to execute the plan. Monitor and report per business process expectations.
• Manage information sharing and project updates and lead escalation of unexpected events impacting project schedule, budget and resources. 
• Oversee knowledge management of the project and standardize processes and utilizing appropriate technology systems and templates

Skills:

• Project planning, scenario planning, & scheduling
• Tracking team deliverables and actions
• Risk management
• Decision facilitation
• Resource management
• Team and meeting management
• Effective communication
• Software tools, such as Google Suite, Microsoft Office, Video Conferencing, Visio, MS Project, Smartsheet, Trello

Experience & Education:

• A minimum of 6 years total work experience with at least 3 or more years relevant experience in the medical device or pharmaceutical/biotech industry
• BS/BA (Engineering/Science preferred) or advanced degree
• Project management certification(s) preferred

Duration Expectation:

• 1 – 3 years

We are looking for individuals to support our team who are comfortable with ambiguity and tackling tough challenges, have an entrepreneurial spirit, have an agile mindset and have an ability to quickly adapt to new environments. Ability to collaborate is crucial as success is measured as a project team, not just as an individual.  

Covid Notice:

• Important: Genentech has mandated COVID-19 vaccination for their workforce, effective October 1st, 2021. All external personnel providing services to Genentech are required to comply with this requirement.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.