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.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
TDL Center for Breakthrough Medicines is seeking a highly experienced, motivated and dedicated Director of Training. The Director of Training’s primary role is leadership role over the training department. In this position, the Director of Training oversees all activities of the department and identifies the organization’s developmental needs ensuring that there is consistency with core competencies and goals. S/he will lead the training team and is responsible for the assessment and identification of the department’s training and development needs and for the effective coordination of training and development programs for the organization. The Director of Training is expected to maintain a consistent culture with regard to training and development and is responsible for the creation, implementation, and improvement of all department-wide training efforts.
- Ensure the strategy for Training is scalable with the development of the site training program and is optimal for the future workforce of CBM, and is compliant with FDA 21 CFR PART 11, where applicable
- Build training department through strategic hiring and create training department model to meet the expanding site hiring and training plan. Team responsibilities to include:
- Create new employee/site training program and oversee the onboarding of new hires
- Closely work with the Assets and Quality Team to build the training
- In collaboration with IT and Facilities, create new hire site access training
- In collaboration with the Health, Safety, Environment Department, create site safety training program that meets the requirements for worker safety consistent with OSHA standards
- Create a comprehensive GMP training program and facilitate training of new hires and existing employees
- Create Aseptic training program and facilitate training for new hires. Create annual re-evaluation process for aseptic operators
- In collaboration with the manufacturing/lab/functional areas, create area/job/process specific trainings required per position/job function
- Develop a ‘train the trainer’ program to develop trainers for manufacturing/lab/functional area specific training
- Create FDA/Health Authority Inspection Readiness training
- Annually organize/facilitate Development Workshop for Executives/Senior Leadership
- Create method to obtain employee satisfaction data and develop employee focused programs to improve employee retention
- Create people manager training program in collaboration with HR, focused on developing team leaders in the organization
- Create feedback and a training evaluation program to measure training effectiveness and continuously improve training program based on feedback
- In collaboration with HR, create and facilitate training program focused on professional development and development planning for all site employees to maximize employee potential
- With HR, create a program for accelerated development of high potential employees
- Coordinate/facilitate team building workshops such as DISC/Insights Discovery
- B.S. and 9+ years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical or MS and 7+ years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical or Ph.D./PharmD/ MD and 4+ years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical
- Demonstrated knowledge of instructional design, development as well as project management expertise
- Advanced business knowledge of Clinical Research & Development, Pharmacovigilance, and/or Regulatory in the pharmaceutical industry
- Demonstrated ability to manage multiple, highly complex projects concurrently
- Prior experience in monitoring adherence to compliance-based training programs
- Ability to implement large-scale change in complex, matrix organizations
- Required Computer Experience: LMS administration and processing; proficiency in Microsoft Office, Adobe Acrobat, Sharepoint development and maintenance, course development products and survey tools