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 Technical Laboratory Training Coordinator is a laboratory operations role that works cross-functionally with Testing Management, Site Training and Technical subject matter experts across Center for Breakthrough Medicines to develop and maintain a technical training program that meets the skills-based training required of the laboratory staff.  

Responsibilities

·      Develops and maintains a training program that meets the technical needs of each of the testing laboratories in Analytical Development and GMP Testing Operations

·      Develops Training Curriculums with each technical subject matter expert / Qualified Trainer for skills-based training and different levels of the laboratory testing staff

·      Develops Training Matrix tools for tracking of skills-based training for new or current staff

·      Schedules and performs training of new or current staff

·      Performs competency assessments of new and current staff through performance, metrics, new assays developed and training matrices

·      Coordinates training schedules for new hires

·      Assists with the development of scientific training / training academies for each of the individual laboratories

·      Coordinates regular review of the training modules and develops new modules or improves current modules based on the business needs

·      Coordinates external training when appropriate (new equipment, new technology)

·      Maintains Training Calendar for Testing & Analytical Services

·      Coordinates with Site Training Director to establish Employee Training Files and Regular process for review

·      Develops and issues training metric reports

·      Conducts gap assessment for training deficiencies / needs analysis

·      Assists in audits and inspections when required

·      Develop training curriculum for Qualified trainers to establish additional training resources

·      Report to management routinely on progress of new hires and maintain progress to plan logs for new and current employees

·      Develop or create On the Job Training aides

·      Participates in Safety and Continuous Improvement Initiatives

·      Ensures Testing & Analytical Development staff meet completion dates and compliance with SOPs and cGMP compliance and all other relevant company training requirements

Qualifications

·      Training & Coordination Experience

·      Excellent written and verbal communication skills and ability to influence others

·      Excellent critical thinking and problem-solving skills

·      Detailed and results orientated

·      Able to professionally handle multiple and sometimes competing priorities

·      Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment

·      Ability to lead multi-disciplinary project teams

·      Proficiency in Microsoft Office programs including Word, Excel and MS Project

·      Proficiency with ERP, CRM, and Documentation Systems

·      Ensures accuracy and relevance of assigned training curriculum

·      Drives timely completion of training for employees to meet regulatory requirements

Performance Management, coaching, mentorship, and development of employees

Education & Experience

·      Bachelor’s degree in a scientific discipline required, with demonstrated laboratory experience in a regulated setting (cGMP, ISO, CLIA / CAP)

·      Experience in managing or teaching people.

·      Good oral and written communication skills, well organized with attention to detail, familiarity with common computer programs and ability to support e-learning

·      Ability to work with individuals one-on-one or teach as a group. Ability to follow a training curriculum schedule for multiple new hires at differing levels.

Training design and development experience a plus.