Sr. Project Manager, Sterile Compounding

You Will:

• Drive end-to-end sterile and injectable compounding launches (503a and 503b) through concept, due diligence and formulation mapping, ingredient sourcing, R&D, piloting, quality and compliance, testing, machinery and tooling readiness, pharmacy operations management, and all necessary safety, facility, equipment and people management requirements for launch readiness.
• Support facility-related initiatives including process improvements, space utilization, cleaning protocols and operations, R&D and scale-up processes, and production optimizations.
• Lead pharmacy initiatives include pharmacy performance assessments, staffing and operations assessments, drug control services, analytics implementation, maintenance, gap analysis, training, inventory optimization, regulatory reviews, and quality assurance.
• Be a subject matter expert for 503a and 503b sterile compounding process and facility requirements, including FDA, DEA, and Boards of Pharmacy.
• Work cross-functionally across Legal, Regulatory, Quality & Compliance, R&D, Operations, Marketing, Medical, and Supply Chain on a regular basis.
• Schedule and lead cross-functional meetings, status calls, and deliverable reviews, regularly taking organized notes and sending meeting summaries.
• Manage each stage of the approval process and ensure proper alignment along the way.
• Act as the internal source of truth and main point of contact for assigned projects across the organization, leading meetings and guiding teams through launch details as needed.
• Anticipate risks and solve for roadblocks proactively, escalating appropriately.
• Prepare documentation and presentations to lead leadership and C-Suite updates.
• Work closely with our EMR, Telemedicine, and CX teams to create documentation that supports the organizational efforts required to train and support launch, including the creation of educational decks and documents, the leading of informational cross-functional meetings, etc.
• Continuously follow up with team members to ensure the group remains on task to meet deadlines, proactively escalating issues to minimize the risk and avoid delays.
• Strictly follow the defined PM processes and suggest workflow improvements as optimizations arise.

You Have:

• 8+ years of project management experience in end to end product development, supply chain, and/or operations. Pharmaceutical experience is a plus.
• 4+ years of sterile compounding project management in 503a and/or 503b facilities
• Experience operating within product-driven organizations with many stakeholders and with fast-moving programs
• Excellent verbal and written communication skills
• Experience managing various stakeholders and being flexible to different working styles
• Extreme attention to detail and documentation
• Strong leadership and relationship-building skills with an ability to quickly make decisions while remaining objective
• Can-do, positive attitude that enjoys managing multiple projects and tasks simultaneously
• Curious and collaborative mindset with the ability to foster teamwork at all levels of the organization