Our Cell Therapy client in Houston, with A-List partnerships; is growing and looking to add a QC Manager to their team! This is an exciting role as the QCM will build-out the QC function/lab! This role is a newly created role and the first within the QC development. Will be expected to work in a matrix type environment and cover various facets of the department. Also, will be a hands-on role and some lab work is expected in support of GMP. Role will create/develop procedures and processes for the new QC Lab, support on-site operations, and activities at partner CMO/CRL, have some knowledge in Analytical, EM and Micro testing, implement sampling plan, release, and retain program for incoming raw materials. Will also be responsible for testing of samples (in-house and at CMOs), experience with cell-based assays, flow cytometry and be the SME for deviations, quality/lab investigations, OOS, CAPAs and change controls. Other duties include but not limited to:
- Create general Quality Control systems and procedures to govern on-site testing for GMP manufacturing facility
- Knowledgeable in routine environmental monitoring and microbiology testing of GMP facilities
- Establish and manage the Stability Program for critical raw materials, in-process, DS or DP, as needed
- Develop GMP systems to govern equipment usage
- Assist in maintaining laboratory equipment, as applicable
- As team will grow, hire, develop and manage FTE’s
- Bachelor’s degree (BS) in a scientific discipline or related degree, and 8+ years of direct experience in quality control with minimum of 2+ years in management or supervisory role. Ideal candidates will have Cell therapy or Biologics experience in on-site manufacturing.
- General knowledge of both Analytical and Microbiology Quality Control requirements
- Able to multitask and support various projects and teams
- Expertise with Microsoft Office; Word, Excel, and Microsoft Project
- Experience with electronic document management systems a plus
- Experience with an electronic compliance management system a plus
**Must be eligible to work for any U.S. Employer for an indefinite amount of time.