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.
QC Scientist, Microbiology CAR-T
1. Purpose and Scope of Position
The QC Scientist is responsible for supporting Quality Control microbiology testing for release of clinical and commercial products and environmental monitoring. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, the QC Scientist will assist with training and assay transfer.
2. Required Competencies: Knowledge, Skills, and Abilities
- Advanced hands on experience with various microbiology techniques and environmental monitoring.
- Advanced ability to accurately and completely understand, follow, interpret and apply Global
Regulatory and cGMP requirements.
- Advanced technical writing skills.
- Advanced problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to set priorities of the group and manage timelines.
- Ability to work with management locally and globally.
- Advanced ability to communicate effectively with peers, department management and cross- functional peers.
- Working knowledge of LIMS.
3. Duties and Responsibilities
Perform environmental monitoring and testing of in-process, final product, and stability samples.
- Utilize scientific principles to assist in microbiological testing methods and the proper use of laboratory equipment.
- Anticipate and troubleshoot problems.
- Recommend corrective actions and participate in development of best practices.
- Understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
- Complete all work in a timely manner.
- Work and communicate effectively within the team to ensure timelines are met.
Perform peer review of testing data.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Complete all reviews in accordance with required release timelines.
- Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Train new analysts to general job duties.
- Complete necessary training to become a qualified trainer.
- Perform training effectively.
- Document training per procedural and cGMP requirements.
Support document revision, project, CAPA, and investigation/deviation related tasks.
- Perform assigned tasks within a CAPA, deviation, or project.
- Participate in complex projects and continuous improvement efforts.
- Take a leadership role, as required, for projects.
- Draft and review technical documents, such as SOPs and protocols/reports.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
Performs other tasks as assigned.
4. Education and Experience
- Bachelor’s degree required, preferable in Science.
- 5-8 years of relevant work experience, preferable in a regulated environment.
- An equivalent combination of education and experience may substitute.
- Experience working in clean room environments and with cell therapy products preferred.
5. Working Conditions
- The incumbent must analyze numerical values on a daily basis.
- 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.
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.