Training Specialist, QC Systems and Services CAR-T
Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.Training Specialist, QC Systems and Services CAR-TSummit, NJ
1. Purpose and Scope of Position
The Training Specialist is responsible for managing the training program for analytical and microbiology CAR-T QC laboratories. This includes, but is not limited to, establishing and maintaining curriculum for QC personnel, assisting with on the job training, and working with SMEs to schedule training. Additionally, the QC Training specialist will assist in the management of the training laboratories and with related projects in support of maintaining training proficiency. This position will work closely with the site's training and development team.
2. Required Competencies: Knowledge, Skills, and Abilities
- Intermediate knowledge of cGMP training requirements
- Intermediate knowledge of cGMP Learning Management Systems and other enterprise applications
- Knowledge of cGMP training software and aids
- Intermediate proficiency with Learning Management Systems (LMS), for example ComplainceWire
- Knowledge of cGMP Regulations and how they apply to QC laboratory activities
- Experience in performing training in a cGMP regulated environment
- Advanced written and verbal communication and presentation skills
- Proficiency in Microsoft Office applications
- Strong collaboration and organization skills
- Ability to challenge processes to improve quality, efficiency, and compliance
- Ability to work collaboratively on cross-functional teams
- Ability to set priorities for the QC training group and manage timelines
3. Duties and Responsibilities
Develop and maintain training curriculum
- Work with QC SMEs and training department to establish appropriate curriculum for lab personnel
- Work with QC SMEs and training department to complete new hire training
- Work with training department and SMEs to ensure that QC lab personnel are appropriately trained to perform relevant tasks
- Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding
- Utilize training resources across multiple groups
- Implement best training practices as appropriate
Manage Training Laboratories
- Assist in the establishment of Training laboratory facility to accommodate on the job training across multiple QC methods
- Maintain training laboratories including training schedules
- Manage and facilitate on the job and instructor lead training
· Independently develop and write training materials/documents
Serve as Training SME
- Support enterprise training and other departmental training as appropriate
- Develop and deliver training presentations on pertinent topics to large groups of including annual refresher training, remedial training and on as a needed basis to support QC
- Process, file and maintain training records
- Run adhoc reports for personnel or groups using LMS
- Maintain training metrics
- Provide guidance and coaching, mentoring, and support that focuses on performance improvement
- Serve as author or technical reviewer of appropriate departmental procedures
- Perform approvals for relevant training activities
Performs other tasks as assigned.
4. Education and Experience
- Bachelor's Degree preferable in Science, or equivalent relevant experience
- Advanced Degree preferred
- 5 - 8 years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program
- Experience with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211
- Experience and understanding of biological manufacturing processes and aseptic techniques a plus
- An equivalent combination of education and experience may substitute
5. Working Conditions
- The incumbent will be working in a laboratory setting up to six (6) hours per day.
- The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.