Celgene Scientist, QC Sample Management in Warren, 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.
Scientist - Sample Management, QC Systems and Services Warren, NJ
Sr. Supervisor - Sample Management, QC Systems and Services
- Purpose and Scope of Position
The QC Scientist for Sample Management works with minimal supervision and is responsible for the management of QC samples and materials in support of the analytical and microbiology CAR-T QC laboratories. This includes, but is not limited to, materials inventory management, retains management and sample tracking and delivery.
- Required Competencies: Knowledge, Skills, and Abilities
Proficient in the use of LIMS and sample tracking software
Working knowledge of Lean Labs
Proficient with enterprise applications
Experience with cold chain sample storage and transfers
Advanced ability to work in a collaborative team environment
Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
Ability to set priorities of the sample management group and manage timelines
Ability to author, review and revise SOPs
- Duties and Responsibilities
Manage Test Samples and Retains
Responsible for the management of test samples including receipt, storage, distribution and transfer and disposal
Responsible for the management and long-term storage of retains and reference samples
Maintain sample tracking and chain of custody records in accordance with cGMP requirements and written procedures
Ensure that obsolete/expired samples/materials are destroyed/disposed according to written procedures
Perform sample queries and periodic storage reports as required
Assist management with investigations and deviations related to sample management
Collaborate with other departments to identify and implement process efficiencies
Train laboratory and production personnel on the sample management process
Manage Lab Inventory
Responsible for inventory management of lab supplies including reagents, media, consumables, etc.
Responsible for reference standard inventory and distribution
Ensure that materials are appropriately labelled and traceable as per appropriate cGMP, regulatory requirements, and written procedures
Assist management with investigations and deviations related to lab inventory
Implement 5S principles as appropriate
Implement FIFO as appropriate
QC Materials Support
Maintain sample management metrics
Facilitate Cold chain transfers as required
Liaise with supply chain, warehouse and lab service to ensure supply stocks
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
An equivalent combination of education and experience may substitute
- Working Conditions
The incumbent should be able to distinguish colors and possess correctable vision to 20/20
The incumbent will be doing light to moderate lifting and carrying (or otherwise moves) objects under 15-20lbs
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.
The incumbent may be exposed to fluctuating and/or extreme temperature on occasions
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.