ElevateBio · 2 weeks ago
Senior Manager, CMC Operations & Program Management
Pittsburgh, PA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. The Senior Manager, CMC Operations and Program Management will lead cross-functional activities between CMC groups and other departments, ensuring alignment with corporate goals and timelines.
BiotechnologyGeneticsLife ScienceTherapeutics
Responsibilities
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
Qualification
Required
B.S. in a scientific or engineering discipline
8 or more years of relevant experience in the CMC environment
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
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
Preferred
Some experience in cell/gene therapy is preferred
Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred
Company
ElevateBio
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.
201-500 employees
H1B Sponsorship
ElevateBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (19)
2023 (17)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
Company data provided by crunchbase