Associate Director, Cmc Project Manager (Remote) - 23-178

Description

Elevar is seeking an Associate Director, CMC Project Manager to join our Manufacturing and Supply Chain department. The Associate Director, CMC Project Manager will translate the CMC strategy for a given project into a comprehensive operational plan, including gap analyses, risk assessments, mitigation planning and resource requirements. He/She will plan, coordinate, and deliver CMC activities in line with project requirements and timelines; plan and monitor resources and expenses for product development through commercial production; and provide support for long term strategies. The Associate Director, CMC Project Manager will be skilled in pharmaceutical late phase drug development and commercialization to support project management of our CMC and supply activities in conjunction with internal and external subject matter experts. This is a remote-based position located in the United States.

Responsibilities:

• Provide project management support for CMC and supply chain activities to support development, manufacturing, release and shipments of drug substance and drug product, analytical method development and transfer, stability, and supply chain related activities
• Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items
• Support CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets)
• Provide project management expertise and application of key project management tools to support the design and execution of project plans and enhance project delivery and information dissemination to the business
• Collaborate with functional representatives, within cross-functional project teams to align CMC activities and to develop risk mitigation and contingency scenarios for projects as needed
• Facilitate planning of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
• Work with external partners to ensure on-time delivery of near-term goals as well as drive strategic discussions and alignment towards the long term goals
• Manage CMC activities, project budgets, expenses and resources for specified projects, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies

Requirements

• Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles
• Experience working in cross-functional, global, virtual environments. Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors
• Experience in a cGMP environment is required; drug substance and/or drug product manufacturing experience preferred
• Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred
• 5 years of technical CMC small molecule experience in the biotechnology or pharmaceutical industry
• Demonstrated ability to exercise independent judgment and strategic thinking with minimal supervision
• Bachelor’s degree with 12 years in Life Sciences or Engineering; or Master’s degree with 8 years; or PhD with 5 years experience. Proven management experience demonstrating business acumen, developing and delivering functional/department goals, delivering results, championing innovation, coaching and developing subordinates including remote and cross functional teams
• Minimum of 2 years’ experience in Project or Program Management at a biotechnology or pharmaceutical company with direct involvement in the CMC area
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
• Strong understanding of pharmaceutical product development, including US and EU pharmaceutical regulations

The anticipated annual base salary range for this role is $155,000 to $185,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.