Celgene Associate 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.
Associate Scientist – QC Sample Management Warren, NJ
Sr. Supervisor - Sample Management, QC Systems and Services
- Purpose and Scope of Position
The Associate Scientist for QC Sample Management works with supervision and is responsible for the movement of QC samples and materials in support of sample management in the CAR-T QC laboratories. This includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking and delivery.
- Required Competencies: Knowledge, Skills, and Abilities
Experience with cold chain sample storage and transfers
Ability to don appropriate gowning and work in classified cleanroom environment
Ability to work in a collaborative team environment
Prior experience and ability to follow 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 review and revise SOPs
- Duties and Responsibilities
Test Samples and Reagents
Responsible for movement of QC test samples including receipt, storage, distribution and transfer and disposal
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
Maintain inventory of lab supplies including reagents, media, consumables, etc.
Maintain 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
Maintain 5S and FIFO principles as appropriate
QC Materials Support
Support 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
2+ 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 (8) hours per day.
The incumbent will be working around biohazardous materials, including chemical agents, up to six (8) 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.