Job description – Bioassays Manager – Technical Services

Cognate is currently searching for the perfect candidate to incorporate into our new QC Technical Services team. The successful candidate will serve as the bioassays subject matter expert and leader of our bioassays team focused on assay technology transfer including critical GMP evaluation of new client assays and documentation, oversight and participation in bioassay test method establishment and document conversion at Cognate, training of analysts on new bioassays methods and instrumentation (as applicable), drafting of bioassay qualification/validation protocols and reports and serving as client point-of-contact for bioassay-related inquiries. This position requires a strong background and understanding of immunology (especially with respect to current cell-based therapies) and wide technical expertise in assay-based cell characterization methods for analyzing cell function/potency in vitro. 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 during the tech transfer phase, and interact regularly with senior staff and clients.
 

DUTIES AND RESPONSIBILITIES:

  • Significant cell culture experience and understanding
  • Project leader for assigned client tech transfer initiatives with responsibility for directing junior and mid-level staff to accomplish tech transfer completion
  • 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 in combination with novel ideas as required (cell-based assays, ELISA, flow cytometry, PCR/other molecular biology-based assays)
  • Basic understanding of emerging T cell / CAR T biotechnology
  • Study design, data/statistical analysis (e.g. use of SigmaPlot, JMP and Excel), 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 technology transfer.
  • Working knowledge of assay qualification/validation approaches consistent with ICH Q2.
  • 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.
  • Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.
  • Ability to problem solve and troubleshoot as necessary
  • Other duties, as assigned

 

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
  • Willingness to train and involve less experienced staff on new techniques as part of technology transfer and assay qualification/validation

 

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