Director, Quality Control Microbiology

Director, Quality Control (Cell Therapy)

 

  HireMinds is seeking a Quality Control leader to help our client oversee a diverse portfolio of cell and gene therapy products. In this role you will be relied upon to oversee the cGMP microbiology function and team of technicians in aseptic and clean room ISO 14644 standards. You will work with Quality Assurance and Manufacturing teams to comply with U.S. and Global standards and regulatory procedures to ensure quality testing is in place. If you are seeking to lead quality control and join and amazing effort check this exciting role out for the new year! Contact the HireMinds Biotech team today to learn more.

In This Role You Will:

  • Work cross-functionally to develop QC microbiology systems that meet the standards expected by US and Global regulatory authorities in support of clinical stage cell and gene therapy products including cGMP and ISO 14644
  • Implement and refine the environmental monitoring program and contamination control strategies using risk-based analyses
  • Develop and qualify microbiology test methods to meet the company’s quality standards and applicable regulations for cell and gene therapy products
  • Oversee team’s routine environmental monitoring and safety testing of cell and gene therapy products, ensuring that all work is carried out per cGMPs and applicable policies and procedure
  • Regularly
  • Review and approve microbiology laboratory SOPs, protocols and reports
  • Oversee microbiology laboratory excursions including: deviations, OOS, OOT and atypical investigations
  • Assist with QC oversight of regulatory inspections and facility audits
  • Oversee and be responsible for hiring, training, and mentoring a team of QC microbiology peers

In This Role You Are Required To Have:

  • BS/MS degree in Biochemistry, Microbiology, or related field with 12+ years of Biopharma experience
  • Experience with Cell or Gene Therapy products under cGMP standards in Quality Control microbiology lab setting
  • Previous work examples of  procedures and protocols associated with aseptic processing and clean room qualification  (ISO 14644)
  • Experience with safety testing including: bioburden, mycoplasma, endotoxin, and sterility
  • Experience with rapid testing methodologies including: BacT/ALERT and PCR
  • Ability to lead QC audit interactions and responses to agencies requests
  • Effective communication and collaborative work style to adapt with a novel and diverse portfolio of cell therapy and immunotherapy products and programs
  • Biotech work ethic with ability to problem solve and troubleshoot on the fly while working within proper quality and regulated standards