Celgene Specialist, QC LIMS CAR-T in Summit, New Jersey
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.
LIMS Specialist, QC Systems and Services CAR-TSummit, NJ
- Purpose and Scope of Position
The LIMS Specialist is responsible for the management of the LIMS (Laboratory Information Management System)/ eLN (electronic lab notebook) in support of the chemistry and microbiology CAR-T QC laboratories. This includes, but is not limited to, maintaining, updating and troubleshooting all LIMS/eLN related issues and assisting with system updates and/or enhancements.
- Required Competencies: Knowledge, Skills, and Abilities
Advanced knowledge of LabWare or related LIMS/eLN
Advanced knowledge of LIMS basic coding and code reviews
Advanced knowledge of validation and/or maintenance of laboratory information systems
Knowledge of cGMP Regulations and how they apply to QC laboratories
Knowledge of analytical/microbiological test methods and environmental monitoring programs
Knowledge of controlled barcode label printing
Knowledge of Crystal Report design
Ability to perform ADHOC inquires
Strong written and verbal communication skills
Detail-oriented with expertise in problem solving; solid decision-making abilities
Strong interpersonal skills
Strong ability to work independently and compliantly
- Duties and Responsibilities
Execute, Create or revise computer system validation documents (i.e. URS, OQ, PQ, etc.) as applicable
Manage all buildouts and changes in LIMS/eLN for the QC lab
Support IT in the Administration of the LIMS/eLN program
Manage change controls for LIMS/eLN changes
Create and maintain user accounts
Troubleshoot issues and solve problems with minimum guidance
Serve as SME for QC LIMS
Provide routine support for end users
Assist with errors and troubleshooting
Provide end user training and on-the-job training (OJT) for laboratory and production employees
Maintain master data objects
Participate in internal audit of the system and system documentation
Assist management with investigations and deviations
Create and maintain all LIMS related SOPs
Support site projects and goals where applicable to streamline testing
Assist management with the development, implementation and deployment of training
Performs other tasks as assigned.
- Education and Experience
Bachelor’s Degree required, preferable in Science
Advanced Degree preferred
5-8 years of relevant work experience, preferable in a regulated environment.
3-5 years of LabWare or related LIMS experience
Previous experience with validation and/or maintenance of laboratory information systems
Previous experience with MODA-EM a plus
An equivalent combination of education and experience may substitute
- Working Conditions
The incumbent will be working 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.
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.