Job description – Manager, QC Flow Cytometry

Cognate is currently searching for the perfect candidate to lead our growing Quality Control Flow Cytometry Team. The successful candidate will serve as a subject matter expert and leader of our flow team focused on client assay technology transfer, management of client assay scheduling and staffing (two shifts), and routine in-process and release testing to meet client requirements and deadlines. The position requires a strong background and understanding of immunology (especially with respect to current cell-based therapies) and wide technical expertise in flow cytometry-based cell characterization methods for analyzing cell function/potency, identity, safety, purity etc. In addition, the ability to work effectively and autonomously as part of a multi-disciplinary team as well as a strong motivation to achieve company goals is a must for candidates seeking this position. A strong desire not only to learn, but also teach less experienced staff is an additional defining characteristic for this position. This individual will be a project leader, responsible for oversight of junior and mid-level staff, and interact regularly with senior staff.
 

DUTIES AND RESPONSIBILITIES:

  • Significant multi-color flow cytometry (7+ years) experience analyzing lymphoid/myeloid cells is required (PBMC, T cells and subsets, B cells, NK cells, dendritic cells, monocytes, macrophages, granulocytes)
  • Strong experience with various industry-standard flow cytometry software packages (particulary FACSDiva and FACS Suite)
  • Expert understanding of flow analysis, compensation and gating strategies for analysis of mixed cell populations.
  • A strong understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control
  • Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.
  • Project leader for assigned client initiatives with oversight of staff
  • Basic understanding of emerging T cell / CAR T biotechnology
  • Study design, data/statistical analysis, reporting results in both written and oral format (presentation)
  • Familiarity with basic core QC areas including product/material stability, trending, comparability, qualification/validation, compendial methods, etc.
  • Excellent writing skills. Experience in drafting of Standard Operating Procedures (SOPs), protocols, reports, etc.
  • Ability to problem solve and troubleshoot as necessary

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • MS or higher degree with 5+ years of cGMP experience in a quality control biotechnology/pharmaceutical environment. Immunology or related degree preferred.
  • Experience working with cell and/or gene therapy products for clinical trials
  • Ability to process large amounts of paperwork in a timely and efficient manner
  • Ability to work in a team-oriented, multidisciplinary and multicultural environment
  • Previous management experience required
  • Willingness to train and involve less experienced staff on new techniques as part of technology transfer or assay developmen

 

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