Simplify Logo

Full-Time

Manager – CMC Operations & Program Management

Contract

Posted on 6/24/2024

ElevateBio

ElevateBio

201-500 employees

Cell and gene therapy manufacturing platform

Industrial & Manufacturing

Mid, Senior

Waltham, MA, USA

Category
Production Planning & Scheduling
Supply Chain Management
Operations & Logistics
Required Skills
Management
Requirements
  • B.S. in a scientific or engineering discipline
  • 3 or more years of relevant experience in the CMC environment. Cell/gene therapy preferred.
  • cGMP 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
  • Extensive experience is leading product/process program within a GMP setting
  • Program management skills, 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 skill
Responsibilities
  • Leading cross-functional teams coordinating and maintaining program timelines
  • Running daily and weekly coordination meetings to manage and resolve activities impacting CMC operations
  • Maintaining integrated program plans and actively managing to keep programs on time
  • Anticipating and managing risks to portfolio and individual programs, implementing mitigation strategies
  • Contributing to the management and review of KPIs at BaseCamp

ElevateBio stands out as a compelling workplace due to its specialized focus on cell and gene therapies, a cutting-edge area of medical science. The company's integrated platforms for gene editing and various forms of cellular engineering, alongside their purpose-built manufacturing platform, BaseCamp, highlight their commitment to process innovation and adherence to cGMP manufacturing standards. This not only positions ElevateBio at the forefront of biotechnological advancements but also offers its employees a dynamic and technically enriching environment to develop their careers.

Company Stage

Series D

Total Funding

$1.2B

Headquarters

Waltham, Massachusetts

Founded

2017

Growth & Insights
Headcount

6 month growth

3%

1 year growth

2%

2 year growth

21%
INACTIVE