Sr. Operations Manager, Nucleic Acids and Plasmid Operations
Overview
Overview

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

The Sr. Operations Manager will play a key, hands on, cross-functional role in translating process design to operational execution. Planning, scheduling, and the coordination of direct and supporting activities to ensure a successful operation will be required. 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. This role will support effective implementation of policies, best business practices, and processes, and procedures.

In addition to operational standup and execution, this position will mange the establishment and improvement of operational metrics via continuous improvement. This will include oversight of cross-functional workstream including but not limited to Process Development, Quality, Procurement, Finance, and Facilities/Engineering. This is a critical role with oversight for the implementation of operational excellence strategies to optimize operational efficiencies with a data-informed and metrics-based approach. This position will influence strategy execution based on the data reporting, KPI management, and process redesign and improvement


Responsibilities

·         Provides operational coordination 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

·         Build and maintain data collection, management, and reporting systems across cross-functional systems

·         Manage metrics, dashboard, and scorecard reporting

·         Diagnose and drive data-based improvements across processes through data analysis, Gemba walks, process monitoring, and employee interviews

·         Work with leadership to develop tactical implementation plans across workstreams

·         Work with leadership to plan and build capacity and capability, identify operational efficiencies, cost savings, and reduce process waste

·         Work with training and leadership teams to execute on operational excellence capabilities for testing teams

Help set up and manage robust and effective communication systems

Education & Experience

·         Bachelor’s degree in science or engineering required. Master’s in science or engineering preferred

·         5+ years of cross-functional experience in biotechnology with a strong understanding of operational excel, continuous improvement, Lean Six Sigma and project management is preferred

·         Lean Six Sigma Certification preferred

·         Excellent data analysis, reporting, and organizational skills 

·         Independent thinker with a track record of working collaboratively in a matrixed environment to achieve goals

·         Highly functioning, process-oriented, and self-starter mind-set required

·         Experience with cGMP, ISO regulated environment is required

·         Excellent attention to detail with strong documentation, communication, and data presentation skills

·         Must be able to thrive in a fast-paced, startup environment with tight deadlines


Special Incentives

TBD