Cognate is currently seeking an Analyst II to perform cell based testing for our Quality Control Department. The successful candidate will be responsible for performing routine quality control product and raw material release testing as well as various biochemistry, molecular bio!ogy, and general laboratory techniques according to GMP. Additlona!ly, the analyst w!II assist QC Scientists with technology transfer of new client assays by Co-authoring SOPs or other required documentation.The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function In a fast-paced, highly technical environment with minimal supervision are essential for success.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strong background and experience with cell-based immunological in vitro methods (e.g. MLR, cytotoxicity, HLA-restriction, CTLp, cell proliferation, etc.) and instrumentation.
Knowledge and technical expertise in areas of assay development, optimization and validation leveraging off-the-shelf technologies such as ELISA, flow cytometry, PCR/other molecular biology-based assays)
Study design, data/statistical analysis, reporting results in both written and oral format (presentation)
An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of an required testing documentation ensuring timely submission relative to product release dates
Adheres to Good Documentation Practices.
Enters observations and results into the appropriate trending databases for periodic analysis and trending.
Assists the QC Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.) Maintains familiarity with QC-relevant cGMP guidances (CFR, USP, EP, ICH, etc.)
Assists with the implementation of quality improvement initiatives for QC laboratory operations Participates in laboratory, OOS, CAPA or other investigations, as required
Maintains laboratory supplies, media and reagents inventory
Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability Responsible for assisting with routine laboratory upkeep and organizationOther duties as required
EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:
BS or higher degree in the biological sciences or related field with a minimum of 4 years relevant laboratory experience or 2-3 years experience in a cGMP/FDA regulated industry
Previous experience working with aseptic techniques and culturing of mammalian cells and familiarity with cell culturing basics.
Familiarity with cGMP as defined in 21CFR210 and 211. Ability to work independently and as part of a teamDetail-oriented with strong written and verbal communication skills Ability to problem-solve and troubleshoot as necessary Experience with CAR-Tis an advantage