Femi Alakija

About Femi Alakija

I am a highly capable, motivated, and experienced nanotechnologist, biotechnologist…

Experience

1. Cell Therapy Manufacturing Specialist

   Lonza

   Jun 2023 — Present · Houston, TX, US

   Responsible for participating in the aseptic processing of clinical-grade products. • Completes GMP documentation and provides accurate information to contribute to any process deviation investigations.• Operates cell processing equipment (LOVO, Sepax, CliniMacs, Nucleofector, Repeater pump, NC-200 cell counter, Gatherex – Grex, Centrifuge, Controlled rate freezer, etc.) according to SOPs, MBRs• Application of LEAN and Six Sigma tools for process, safety, and quality improvement.• Cryopreservation of final drug products.• Coach Black belt, green belt, and yellow belt candidates.• Performs aseptic cell culture manipulations in a Grade A and B environment (Grade B gowning qualified); prepares media, reagents, and different cytokines for patient’s cells.• Participates in assigned customer Aseptic Process Simulations. • Knowledge of ERP (SAP), LIMS, and MODA• Understanding cell-based assays including, but not limited to, morphological assessment, cell proliferation, functional differentiation, and cytotoxicity.• Perform detailed reviews of executed batch records for accuracy, completeness, and compliance with cGMP and internal quality standards.• Performance Monitoring: I Monitor the performance of implemented process improvements to ensure they achieve the desired results. This involves tracking key performance metrics and indicators (KPIs) and adjusting as needed to maintain or improve performance over time.• Identify discrepancies or deviations in batch records and work with cross-functional teams to resolve issues, initiating investigations and corrective actions (CAPA) as needed.• Responsible for the successful development and execution of state-of-the-art manufacturing processes for Current Good Manufacturing Practices (cGMP) within the Cell Therapy Development matrix• Environmental monitoring (EM) in the cell therapy facility to ensure product quality and safety and meet cGMP standards.

Education

• Louisiana Tech University

  Doctor of Philosophy - PhD

• Olabisi Onabanjo University(O.O.U)

  Bachelor's degree

• COES Graduate Studies - Louisiana Tech University

  Master's degree

• Stephen F. Austin State University

  Graduate studies

• COES Graduate Studies - Louisiana Tech University

  Master's degree

• Olabisi Onabanjo University(O.O.U)

  Intermediate diploma