Senior QC Scientist, Training CAR T

Employer
Celgene
Location
Summit, NJ, US
Posted
Aug 03, 2018
Ref
1802598
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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.

Sr QC Scientist Training, QC Systems and Services (Microbiology EM) - CAR T
Summit, NJ

1. Purpose and Scope of Position

The QC Senior Scientist Training is responsible for managing and administering the training program for analytical CAR-T QC laboratories. This includes, but is not limited to, establishing and maintaining curriculum for lab personnel, assisting with on the hands on, and working with SMEs to schedule training. Additionally, the QC Senior Scientist Training will manage the microbiology training laboratories and assist 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
  • Advanced knowledge of cGMP training requirements
  • Advanced knowledge of QC Laboratory functionality
  • Advanced hands on knowledge of various microbiology and environmental monitoring techniques
  • 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
  • Experience with cGMP Learning Management Systems and other enterprise applications
  • Strong collaboration and organization skills
  • Ability to work collaboratively on cross-functional teams
  • Advanced Ability to teach and coach
  • Proficiency in Microsoft Office applications


3. Duties and Responsibilities

Develop and maintain training curriculum
  • Work with lab SMEs and training department to establish appropriate curriculum for lab personnel
  • Work with lab SMEs and training department to complete new hire training, analyst qualification and requalification
  • 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
  • Establish Training laboratory facility to accommodate hands on training across multiple microbiology and environmental monitoring QC methods
  • Maintain training laboratories including equipment, training materials and training schedules
  • Manage and facilitate instructor lead trainings and on the job trainings
  • Independently develop and write training materials/documents
  • Serve as Training SME
  • Support microbiology and environmental monitoring techniques training and other departmental training as appropriate
  • Complete necessary training to become a qualified trainer
  • Perform training effectively
  • Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including annual refresher training, remedial training and on as a needed basis to support QC
  • Process and file training records
  • Maintain training metrics
  • Perform approvals for relevant training activities
  • Author and review training documents as required

Performs other tasks as assigned.

4. Education and Experience
  • Bachelor's Degree, preferable in Science, or equivalent relevant experience
  • Advanced Degree preferred
  • 7-10 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-POST

Celgene 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.