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Associate Scientist, Quality Control
4 months ago
The Associate Scientist, Quality Control (QC) reporting into the Senior Director, QC will execute QC operations in support of manufacturing and will have technical lab experience and have strong industry experience. The role requires advanced ability to set priorities, manage timelines and represent the interest of the group on cross-functional teams.
Principal Duties/Responsibilities:
- Execute QC operations in support of manufacturing, including in process testing and lot release QC testing
- Recommend corrective actions and participate in development of best practices;
- Review all data in accordance with applicable procedures and cGMP requirements;
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment;
- Laboratory and equipment maintenance
- Primary cell culture and maintenance of cell lines for release testing
- Work and communicate effectively within the team to ensure timelines are met;
- Perform peer review of testing data;
- Understanding of regulatory guidelines
- Ability to independently develop, write and execute methods, protocols, reports and other related documents;
- Anticipate and troubleshoot problems;
- Perform testing of in-process, final product, and stability samples;
- Complete all work in a timely manner
Qualifications:
- B.S. in cell and molecular biology, immunology, biochemistry, or another Life Science field, with a master's degree preferred.
- Minimum of 6 years technical lab experience and a minimum of 3 years related industry experience
- Ability to communicate effectively with peers, department management and cross- functional peers;
- Ability to set priorities of the group and manage timelines;
- Ability to work with management locally and globally;
- Ability to represent the interests of the group on cross-functional teams;
- Hands on experience with various bioanalytical techniques including ELISA, qPCR and FACS/Flow Cytometry;
- Hands on experience with sterile primary cell culture techniques.
- Problem solving ability/mentality, technically adept and logical;
- Technical writing skills.
Work Environment:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.
