CBM

Full Time EE - Onsite

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

The Operations Engineer will play a key, hands on, cross-functional role in translating process design to operational execution. This role will facilitate operational coordination across and collaboration with internal and external key stakeholders to drive results, deliverables, and timelines for internal projects and initiatives. The Operations Engineer will support effective implementation of policies, best business practices, and processes.   

Responsibilities

• Provides operational coordination for Testing and Analytical Services across a cross-functional team for internal projects in laboratory services, supply chain, quality, IT, facilities and engineering, and client project management 
• Collaborates with internal and external key stakeholders to drive results, timelines, and deliverables for a portfolio of projects and initiatives within budget 
• Supports the efficiency of existing processes and procedures to enhance and sustain internal capacity 
• Ensures timely and effective communications within the business unit 
• Executes against an operational process design and reports back opportunities, challenges, and gaps 
• Supports change management and continuous improvement efforts 
• Helps monitor, and interpret operational metrics to drive efficiency and improvement projects 
•  Participates in interpretation, analysis, and actionable improvements 
• Adheres to cGMP compliance and leads efforts to seamlessly integrate compliance into business processes 
• Contributes to and supports technical writing efforts, including but not limited to drafting, editing, and improving SOPs that meet both compliance requirements and foster best business practices 
• Helps foster a high performing cross-functional, matrixed team through collaboration, communication, time management, and accountability  
• Duties as assigned by management

Education & Experience

• Excellent written and verbal communication skills and ability to influence others 
• Excellent critical thinking and problem-solving skills 
• Detailed and results oriented 
• Strong understanding of data analysis and ability to communicate impact of metrics 
• Able to professionally handle multiple and sometimes competing priorities 
• Ability to coordinate multi-disciplinary project teams 
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment  
• Proficiency in Microsoft Office programs including Word, Excel, MS Project, and Visio 
• Experience with operational systems and databases 
• Ability to thrive in a dynamic, fast growing, startup environment and ability to adapt and flex as needs require