Job Description Summary
STEMCELL’s Quality Control department has an opening for a Senior Quality Control Analyst, to join the CELLCore team. The Sr QC Analyst will perform day to day operations related to cell bank manufacturing and quality control testing of master and working cell banks, perform subcloning and isotyping of hybridomas, and other core cell bank facility activities.
The role may also involve technology transfers, testing of finished products, in-process products and raw materials and performing experiments related to troubleshooting, stability testing and other product-related issues.
This is a dynamic position that involves manufacturing, cell characterization, and quality testing of cell banks used as in-process products and stem cell banks used in quality control final product testing.
Our team is looking for members who can collaborate effectively with other members of QC and other cross functional groups.
Duties and Responsibilities
Perform cell culture from thawing through cryopreservation and banking of hybridomas, CHO cells and other mammalian cell lines used for antibody and protein production.
Perform subcloning of hybridomas by limiting dilution and evaluate supernatant antibody titre and specificity.
Perform cell culture media adaptation techniques and characterization of cell lines.
Perform specialized cell culture assays and techniques including monitoring cell proliferation, confluence, morphological assessment, cell health, cell identity / authentication and stability of cell lines.
Maintain cultures of pluripotent stem cell maintenance and non-maintenance cell lines.
Differentiate pluripotent stem cells into progenitor cells and other cell types of interest.
Media and reagent preparation for conducting any assay as described. Preparation of cell banks to meet various project demands.
Perform a variety of cell based and analytical assays to QC test in-process materials and products according to established Standard Operating Procedures (SOPs).
Development and improvement of QC testing procedures, writing or revising SOPs and working documents, reports or templates.
Investigate and document out-of-specification results and non-conformances to support and maintain Quality Systems requirements.
Complete batch records, analyze data and accurately complete QC testing reports using good documentation practices (GDP).
Complete SAP manufacturing operation duties for cell bank inventory and technology transfers.
Apply a quality mindset and critical thinking skills to all aspects of work conducted.
Communicate with supervisors and coworkers to promote a safe and cooperative working environment.
BSc or MSc in Biology, Biochemistry or Immunology with emphasis on Cell Biology.
BSc or technical degree with 2 to 4 years related laboratory experience; or MSc with 0 to 2 years post graduate related laboratory experience.
Excellent laboratory skills including aseptic technique, cryopreservation and banking of cells and work experience in a cell culture environment, culturing varying 2D / 3D cell lines.
Knowledge of and follows good cell culture practice guidelines.
Experience with live-cell imaging, cell subcloning, ELISA, antibody titre quantification, and iso-typing is highly desirable.
Previous experience in either a manufacturing setting or core facility is desirable.
Ability to work with precision and accuracy.
Excellent attention-to-detail and record-keeping skills.
Excellent analytical, critical thinking & communication (oral & written) skills.
Familiarity with ISO 13485 standards, Quality Systems and writing Standard Operating Procedures (SOPs).
Demonstrated ability to work cooperatively in a team setting.
Proficiency with Microsoft Office Suite and Google Applications.