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 Manager will play a key, hands on, cross-functional role in managing process design to operational execution. This role is accountable for operational management across and collaboration with internal and external key stakeholders to drive results, deliverables, and timelines for internal projects and initiatives. The Operations Manager will drive effective implementation of policies, best business practices, and processes to support client projects, and capability stand up initiatives.

Responsibilities

• Provides operational management 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
• Manages supply chain initiatives to support client project management and capability stand up initiatives
• Collaborates with internal and external key stakeholders to drive results, timelines, and deliverables for a portfolio of projects and initiatives within budget
• Manages the efficiency of existing processes and procedures to enhance and sustain internal capacity
• Secures resource needs from appropriate departments for respective internal projects, including escalations to senior management and/or leadership teams
• Ensures timely and effective communications within the business unit
• Executes against an operational process design and reports back opportunities, challenges, and gaps
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment
• ·      Functions as a change agent and leads change management and continuous improvement efforts
• Helps develop, monitor, and interpret operational metrics to drive efficiency and improvement projects
• Present metrics on a periodic basis. Participate 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

• Bachelor’s degree in a relevant field required; background in science strongly preferred
•  At least 10 years of experience in labs and overall operations, spanning supply chain, IT, facilities and engineering
• Project management and coordination across multi-disciplinary functions required
• Experience working in a matrixed organization
• Data and statistical analysis background strongly preferred

Key Competencies:

• Excellent leadership, 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
• Excellent negotiation and facilitation skills
• Able to professionally handle multiple and sometimes competing priorities
• Ability to coordinate multi-disciplinary functions and teams
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment
• Proficiency in Microsoft Office programs including Word, Excel and MS Project
• Experience with LIMS, ERP, CRM, and Documentation Systems
• Ability to thrive in a dynamic, fast growing, startup environment and ability to adapt and flex as needs require