Specialist, QC LIMS 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.LIMS Specialist, QC Systems and Services CAR-TSummit, NJ
1. 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.
2. 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
- Results driven
3. 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.
4. 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
5. 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.
#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.