About Aerogen Pharma
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.
We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.
Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

Join us as we embark on this breakthrough and become inspired to deliver.

What is the role?
The CMC Senior Program Manager is a critical role in Aerogen Pharma that will develop and implement robust program management tools and drive a culture of accountability to support the delivery of early and late phase pharmaceutical development and commercialization programs. This role is a strategic and operational partner to the functional team lead and functional team to ensure the proper strategy and execution of the project.
What are the key responsibilities?
• Manages CMC project timelines through all phases of development, from project award and kick-off through close-out
• Develops, manages, and updates project plans in a timely manner. Communicates project status, progress, timelines, changes in schedule, scope changes, technical and/or quality issues to team and stakeholders.
• Leads cross-functional teams (e.g., CMC, Clinical supplies) without direct authority by casting a clear vision of project objectives/priorities and motivate the team to achieve them. Able to resolve conflict and foster collaborative partnerships with others to achieve peak performance with some assistance from manager or delegate.
• Manages CDMO / contract lab activities to execute against project plans and escalates issues in a timely manner. Able to resolve conflict and foster collaborative partnerships with CDMOs / CROs.
• Responsible for forecasting and managing project budgets and resources within agreed tolerances.
• Leads CMC risk management - analyzes risk with appropriate stakeholder input, establishes contingency plans and identifies trigger events and responsibility for initiating mitigating action.
• Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals
• Clearly and proactively anticipate, identify, track, communicate, and propose resolution options for discrepancies in priorities and plans, prioritize complex and multiple/conflicting responsibilities and/or issues
• Acts as a contributing member of Program Management Organization
• Leads or contributes to departmental initiatives as appropriate, including procedure development and improvement
• Cross-site portfolio leadership OR process ownership; work with PMO and local team to continuously improve PM and project delivery practices.

What education and experience are required?• Minimum bachelor's degree required, preferably in science or related discipline PMP certification
• Minimum 5 years (PM) or 10 years (Sr PM) of project management experience in biotech, pharmaceutical or clinical development
• Experience in late stage and working with CDMOs is a must-have
• Knowledge of Good Manufacturing Practices, ICH, FDA, Health Canada and MHRA Regulations
• Excellent written and oral communication skills.

What key skills will make you great at the role?• Proven ability to operate effectively across a matrix organization to drive programs according to timelines; ability to articulate project objectives and priorities
• Highly collaborative with outstanding relationship building skills
• Exceptional communication skills
• Dynamic thinker with a sense of urgency and a bias toward action

Why Aerogen Pharma
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.

We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.

Average Compensation: $147,555

How Much Do Aerogen Employees Make?