Senior Specialist, Gmp Consolidation
CurrentProvides leadership to support all activities within GMP Plasmid Manufacturing. • Responsible for guiding all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working in close collaboration with the Associate Director of GMP Plasmid Production, providing hands on support and leadership for all day-to-day GMP production operations, including project timeline management and personnel. Aid in production efforts to deliver all products in a timely, compliant, and responsible manner by providing leadership to staff working in the manufacturing facility as well as hands on training to facilitate operations in a consistent manner following appropriate practices, batch records, and Standard Operating Procedures (SOPs).• Currently facilitating the transition of the Plasmid Production Core into GMP compliance and production. Trained and proficient in plasmid production processes and able to translate that into SOP and MBR fabrications for use and compliance in a GMP production facility. Extensive experience in technical writing to translate production process into the fabrication of documents (tech transfer).• Coordinating the creation and issuance of production documents, materials, and applicable forms between multiple departments. • Training facilitator and mentor for new employee onboarding. • Directly collaborates with Quality Assurance to address investigations, process improvements, CRs, CAPA, sCAPA, and controlled document review. • Leads most production activities while mentoring and training junior staff to ensure process completion in a timely manner. • Responsible for coordinating material/supply and equipment delivery for all GMP Plasmid production activities, as well as chemicals and general gowning needs.
