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 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

Candidate is responsible for providing technical and Good Manufacturing Practices (GMP) training proficiency and consultative guidance as a business partner to assigned Asset and/or Functional group. This position is passionate about training & committed to excellence while ensuring employees are properly trained prior to performance.

Responsibilities

Responsibilities

·      Develops an ongoing Asset Good Manufacturing Practices (GMP) Training Plan to define program deliverables, including justification for topics, measures of effectiveness to be used and an annual summary report.

·      Co-develops training academies with manufacturing and testing operations and oversees the execution and continuous improvement established academies.

·      Conducts needs assessment and performance analysis to determine Good Manufacturing Practices training needs (e.g. evaluation of Quality events, internal or external audit observations).

·      Executes Root Cause Analysis and corrective actions where a training solution is identified.

·      Builds assessments and evaluations to measure progress and to evaluate effectiveness of the Asset / Functional group Good Manufacturing Practices training programs.

·      Establishes and maintains metrics to measure the effectiveness of training and report to management.

·      In collaboration with subject matter expert(s) and Technical & Good Manufacturing Practices Training Instructional Designer, develops training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience (e.g. videos, computer based training, wiki, websites, trainee and trainer manuals, job aids, etc.), including the necessary storyboards, outlines, and project plans.

·      Facilitates Train The Trainer sessions

·      Consults with the Technical and Good Manufacturing Practices (GMP) Training Back Office and reports issues impacting the quality, compliance and effectiveness of the Learning Management System (LMS).

·      Ensure the integrity and compliance of the training system, Conduct/review company level training plan.

·      Performs other duties as assigned.

Qualifications

·      Bachelor’s degree or above, preferred Biologics background

·      Working experience with biopharma process development or production

·      Good Manufacturing Practices (GMP) Knowhow