The 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.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
Provide support for various manufacturing, quality and analytical testing systems. These include industrial control systems, lab equipment, and analytical instruments as well as site and enterprise systems (i.e. MES, PLM, BMS, EMS) for the management of operations, quality, and process development.
This role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs. This role will have the opportunity to lead projects in the deployment of new process and IT capabilities.
For various project assignments/initiatives, the Sr. Automation Engineer is responsible for partnering with Quality Assurance and Manufacturing groups in maintaining cGMP requirements. The role provides multiple opportunities to learn new skills in IT, automation and process analytical technologies and help advance innovative cell and gene therapies to patients.
Understands and supports all GxP environments.
Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.
Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems. Oversees investigations of automation anomalies to prevent recurrence.
Participates in and helps develop training programs for automated systems
Provides on-floor support of manufacturing activities.
Identifies and implements process/equipment improvements and manufacturing efficiencies.
Maintains technical and quality documentation.
Provides client services support for business area applications.
Preferred Experience in:
Basics of networking
Server administration, including virtualization
Experience with data historian, SCADA, PLC and various other industrial automation technologies
Familiar with equipment: Single Use Bioreactors and Other Equipment, QC Equipment and Research Operations.
Education & Experience:
B.S., B.A, or M.S. in Information Technology, Science, Engineering or related field.
Minimum of 5 years experience in an Automation role supporting GMP manufacturing
Effective leadership, interpersonal and communication skills (written and oral) are required.
A working knowledge of regulatory requirements for pharmaceutical applications is highly desirable.
Highly desired are skills in PLCs, SCADA, Batch Operations (S88/S95), IT, and OEM equipment.
Experience in Process Data Analytics is desired.