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.
Sr Supervisor - Sample Management, QC Systems and Services CAR-T
1. Purpose and Scope of Position
The Senior Supervisor for Sample Management is responsible for the management of all 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. The Senior Supervisor will also serve as a backup for management as needed.
2. 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
- Advanced ability to interact with regulatory auditors as a Subject Matter Expert (SME)
- Advanced technical writing skills and oral presentation skills
- Advanced problem-solving ability/mentality, technically adept and logical
- Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Ability to think critically to support quality decision making
- Ability to represent the interests of the QC group on cross-functional teams
- Ability to set priorities of the sample management group and manage timelines
- Ability to mentor and develop personnel
3. 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
- Establish and maintain all related SOPs
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
- Establish and maintain all related SOPs
4. Education and Experience
- Bachelor’s Degree required, preferable in Science
- Advanced Degree preferred
- 7-10 years of relevant work experience, preferable in a regulated environment
- 3+ years leadership responsibility
- An equivalent combination of education and experience may substitute
5. 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.