The Role:

The Senior Manager, CMC Operations and Program Management will lead the cross-functional activities between CMC groups and other departments at ElevateBio BaseCamp including process development, analytical development, facilities and engineering, MSAT, manufacturing and supply chain within the scope of various programs. The Senior Manager will be a part of the BaseCamp CMC and Program Management department and will aid in supporting internal startup/operational readiness of our new BaseCamp Pittsburgh cGMP manufacturing facility and then serve in a program management capacity for tech transfer of external partner programs into the facility. This position will contribute to ensuring alignment with corporate goals and timelines.

Here’s What You’ll Do:

• Build and maintain strong internal relationships with SMEs at BaseCamp (PD, MSAT, Manufacturing, AD/QC, QA, Regulatory, Commercial, F&E) and external relationships with scientific and program management staff at partner organization to ensure program goals and accountabilities.
• Develop, maintain and track CMC project plans (e.g., detailed Gantt, budget, resources, etc.) with SMEs to encompass key program milestones and deliverables in alignment with overall program objectives.
• Facilitate internal CMC team meetings and meetings with BaseCamp partners using meeting management best practices (both what and how) to drive cross-functional communication, timely and effective decision-making, and successful execution of program activities.
• Proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams to develop and implement mitigation plans.
• Generate dashboards indicating key program milestones, updates, risks and challenges.
• Maintain risk registers, decision logs, and change requests.
• Help prepare content for Joint Leadership Meetings
• Support the standardization of processes and communication(s) in order to build efficiencies within the department.
• Contribute to the management and review of KPIs at BaseCamp
• Hold weekly 1:1s with BaseCamp partner counterparts to ensure program milestones are being met.
• Work closely with finance and department leads for invoicing.

Requirements:

• B.S. in a scientific or engineering discipline
• 8 or more years of relevant experience in the CMC environment. Some experience in cell/gene therapy is preferred.
• Experience with tech transfers of advanced therapeutics and/or biologics (e.g., autologous/allogeneic cell therapies, RNA vaccines and therapeutics, viral vectors, mABs)
• cGMP product/program management experience is required.
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred.
• Program management skills are required, including strategic and tactical programs/tasks, tracking and adhering to budgets, reporting program and campaign metrics, and other program management tools.
• Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills.
• Outstanding planning, organization, and multitasking skills