Manager, CMC Project Management

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing treatments for serious metabolic diseases. The Project Manager will lead CMC-related projects within Technical Operations, ensuring timelines, budgets, and deliverables are met while fostering cross-functional collaboration and managing risks.

Responsibilities:

• Oversee and drive CMC project plans, ensuring deliverables align with the overall project objectives and timelines
• Facilitate cross-functional collaboration by leading CMC sub-team meetings, preparing agendas, tracking action items, and maintaining meeting minutes
• Partner with Technical Operations, Legal, and Finance to negotiate and execute confidentiality agreements, consulting agreements, master service agreements, and work orders with CDMOs and CROs, following internal procedures
• Oversee development and execution of integrated project plans, including timelines, budgets, and resource allocation across multiple workstreams
• Partner with Technical Operations, Legal, Finance, and external CDMOs/CROs to negotiate and finalize agreements, ensuring compliance and timely execution
• Monitor and manage project budgets, forecast resource needs, and provide financial oversight to support decision-making
• Proactively identify and mitigate risks, maintaining risk registers and implementing contingency strategies to ensure program success
• Deliver high-quality reporting and communication, including executive-level updates, dashboards, and presentations for governance forums
• Champion process improvements and best practices, driving operational efficiency and consistency across Technical Operations projects
• Other responsibilities may be assigned as required by management

Requirements:

• BS degree required
• 4+ years of experience supporting Technical Operations (Manufacturing, Analytical/QC testing, Packaging, Distribution)
• Excellent communication skills (both verbal and written) and interpersonal skills are required
• Works well independently as well as in a team environment
• Highly proficient in Microsoft Office applications and Smartsheet; comfortable and quick learner with other software systems
• Demonstrates collaborative communication and problem-solving spirit
• Willingness to do what needs to be done in a dynamic environment
• Degree in life sciences/engineering strongly preferred, professional certifications (i.e. PMP) will be a distinct advantage
• Device Development experience highly desired