Technical Development Team (TDT) Project Manager

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The Opportunity

The Technical Development Team Project Manager (TDT PM) partners with a Technical Development Leader (TDL) to manage technical development team(s) in defining and implementing CMC strategies and activities associated with developing clinical candidates from pre-entry into humans until launch. He/she provides project and process management experience including project planning and scheduling, resource forecasting, performance monitoring, and facilitation of communication and decision making to help drive assigned projects to a successful outcome.

Key Responsibilities/Tasks

• Partners effectively with TDL and technical development team (TDT) members to define and deliver the project CMC strategy and objectives in alignment with the Project Team goals, for 3 - 5 projects
• Applies drug/CMC process development knowledge and project management expertise to manage TDT(s) and partners/CMOs for multiple projects across various platforms (including large and small molecules, combination products/devices, new modalities), from pre-EIH though approval
• Establishes and maintains integrated project schedules and manages/reduces risk associated with CMC critical path
• Ensures TDT adheres to timelines and milestones as per approved plans; drives proactive risk assessment
• Drives business processes for TDTs including proactive risk assessment, lessons learned, governance reviews; adapts processes and tools to fit project needs
• Effectively plans & manages TDT meetings and facilitate meeting discussions; drives decision making to reach desired outcomes
• Keeps all relevant stakeholders updated on project status, key risks and issues; keeps all TDT project-related information current in information systems
• Applies agile principles to ensure fit for purpose meetings, fast and focused decisions, transparent communication
• Participates in departmental or cross-functional initiatives and assignments, or business process improvement.
• Acts as a valuable member of the overall Project Team System (e.g. shares best practices and lessons learned)

Who You Are

Minimum Requirements

• BS degree in Life Sciences
• 5+ years in the pharmaceutical/biotech industry
• 3+ years drug development project management experience

Knowledge/Skills/Competencies

• Understanding of the drug development and CMC process development
• Project management experience with a good understanding of PM practices, business processes and tools
• Strong desire to learn and expand CMC knowledge and digital technology advancement. Advocate and drive the digital transformation to project management
• Excellent verbal and written communication skills; must be able to effectively communicate/articulate TDT strategy and deliverables to team members and external business partners
• Strong collaborative and relationship-building skills; demonstrated ability to effectively partner and influence internal and external stakeholders

Preferred

• Advanced Life Sciences degree (M.S/PhD)
• PMP certification
• Relevant process validation, CMC functions, regulatory, quality and cGMP experience

The expected salary range for this position based on the primary location of South San Francisco, CA is $195,200 to $176,800. Annual Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

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.