CBM

Full Time EE

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

Responsibilities

·      Responsible for the daily support of building infrastructure and systems

·      Supports the Facility team engaged in maintaining building infrastructure, services, security, and grounds

·      Monitors work order system and executes

·      Works with the Engineering team to plan and implement equipment, systems and facilities modifications

·      Create and maintain relationships within CFBM to develop and promote best practices and ensures compliance with SOP’s, safe work practices, and cGMP regulations

·      Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities

Coordinates support from site facilities manager for infrastructure and core utilities

Qualifications

·      5+ years of experience in a GMP facilities/manufacturing environment

·      2+ years of experience in a functional maintenance or calibration leadership role

·      Direct experience supporting building facilities and utility systems within a manufacturing/production environment is desirable

·      Understanding of local and state regulations and permitting

·      Experience with the following unit operations or technologies: HVAC design and operations, electrical distribution, compressed gases, clean utilities (steam & WFI), Building Management Systems (BMS)

·      Extensive knowledge in all disciplines of construction, especially GMP utility and cleanroom design/installation and quality control laboratory design/installation

·      Strong understanding of industry standards for equipment qualification, maintenance, calibration, and operation of facilities and utilities for cGMP manufacturing and GXP laboratories

·      Strong interpersonal and communications skills; written and oral

·      Previous proficient experience with CMMS software system(s)

·      Knowledge of OSHA and EPA regulations