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.
The Cell Therapy Training Coordinator will create the training program, training curriculums, training plans/content, and maintain training documentation for the manufacturing staff. The incumbent will be responsible for performing on the job training for manufacturing processes and operating basic equipment as required while maintaining compliance to cGMP standards. This position will participate in the onboarding and training of the inaugural manufacturing staff for the stand up of a new organization.
We are looking for individuals that have experience training multiple people simultaneously, are hard-working, highly motivated, and solution oriented. This position requires multi-tasking, interdepartmental coordination, and excellent communication skills.
· Directly oversees on-the-job training needs with management, outside vendors, and/or clients in conjunction with the site training team.
· Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
· Ensures timely completion and compliance with cGMP and all other relevant company training requirements and apply rigorous quality standards while executing training activities.
· Tracks and reports key quality indicators, training metrics, and participant feedback.
· Ensures work is completed in compliance with approved SOPs, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
· Support closure of training deviations/non-conformances and troubleshooting of equipment problems as needed.
· Facilitates training program and conducts trainer assessments of manufacturing personnel.
· Develops training presentations including training documentation requirements, completions, rosters, certificates, and compliance to share with subject matter experts and work with manufacturing management to develop curricula.
· Works as qualified trainer and performs training as required.
· Develops and updates on the job training requirements, curricula, and skill check assessment checklists as required with manufacturing, quality, and site support departments through job code reviews as the program develops or improvements are identified.
· Creates all levels of training courses (instructor led, self-read, on the job, computer-based) using best training practices and analyzes training trends and reviews quality data to determine opportunities for continuous improvement.
· Prepares and manages a technical training calendar and communication board. Facilitates scheduling of on-the-job training courses.
· Develops mechanisms using the Quality Management System to ensure operators are trained and ready to execute.
· Work together with the Department Training Specialist to ensure completion of all necessary orientation and onboarding training activities.
· Promote an “All In” culture within the team by exhibiting inclusiveness, emphasizing safety, and leading continuous improvement activities through leading by example.
Demonstrate a positive attitude within the team and proven ability to complete assignments on time.
· High school diploma is required, but a bachelor’s degree in biological science(s) field is preferred.
· 3-5 years of GMP Manufacturing experience.
· Experience performing and teaching aseptic technique.
· A minimum of 1 year of technical training, including developing curriculum and course content.
· History of maintaining personnel training and performance metrics.
· Strong knowledge of cGMP regulations and quality management systems.
· Working knowledge of MS Word, PowerPoint, Excel, and Outlook.
· Excellent written and verbal communication and interpersonal skills.
· Exhibits attention to detail, accuracy in work, and integrity of character.
· Self-starter who shows eagerness to learn new opportunities and experiences.
· Innovative and efficient when solving problems with a focus on continuous improvement.
· Possesses aptitude to learn and operate equipment and apply emerging learning technologies.
· Able to adhere to all safety and company regulations.
· Able to accommodate a flexible work schedule to support business demands.
· Knowledge of instructional design, blended learning, contemporary learning methodologies, and Cell Therapy Manufacturing is preferred.
Ability to manage, adapt to, and influence change in a high-pressure environment.
· Ability to carry up to 55 pounds.
Ability to stand for long periods of time while wearing various levels of PPE daily.