The Alfred Foundation · 3 weeks ago
Quality Control Senior Scientist
Alfred, ME
Full-time
Onsite
Senior Level
6+ years expThe Alfred Foundation is a leader in health care delivery, improvement, research and education. They are seeking a Quality Control Senior Scientist to develop and establish analytical methods for the manufacture of clinical cellular therapy products in the CAR-T Facility, ensuring compliance with Good Manufacturing Practices and participating in continuous improvement activities.
Hospital & Health Care
Responsibilities
Establish new methodologies, techniques or assays to evaluate the safety, quality and efficacy of manufactured cellular products
Participate in technology transfer and research and development projects
Establish third-party vendors to validate and perform assays
Establish, perform, coordinate and interpret tests associated with cell therapy, including flow cytometry, cell count and viability, maintenance of cell lines for use in assays, ELISA, qPCR and other cell-based assays and environmental monitoring
Participate in continuous improvement activities
Participate in quality improvement activities in accordance with the Quality Management System, including but not limited to, internal audits, equipment management, non-conformance and out of specification investigations, trending, operational change plans
Ensure compliance with cGMP, PIC/S, OGTR and relevant clinical regulatory requirements
Use of a variety of computer-based applications (MS Word, Excel, PowerPoint Outlook, eQMS, BMS/EMS)
Participate in and deliver training relevant to the role
Flexibility to participate in planned operational tasks on weekends and overtime as necessary
Participate in an on-call roster
Qualification
Required
Bachelor of Applied Science (Medical Laboratory Science) or Bachelor of Science or equivalent. Where 'equivalent' includes a degree awarded by an overseas tertiary institution which is recognised by the National Office of Overseas Skill Recognition
Recognition, which in the case of Medical Scientists is the Australian of Medical Scientists (AIMS)
Background in Haematology, Transfusion Science, Cell Therapy or Stem Cell processing (>6 years' experience)
Minimum 2 years' experience in TGA Good Manufacturing Practices (GMP), with a focus in QC assays and experience in qualification and or validation of cell and gene therapy assays
Preferred
Postgraduate degree in Haematology, Immunology, Cell Therapy or Stem Cell Biology
Benefits
Salary packaging & novated leasing through Maxxia
Flexible health insurance coverage through HCF Health Insurance
Onsite car & bike parking opportunities, deducted pre-tax \\subject to availability
Fantastic onsite fitness facilities at The Alfred through ProSport health and fitness
Childcare services at The Alfred managed by KU Children’s Services
Company
The Alfred Foundation
The Alfred Foundation raises funds to support the incredible work of The Alfred hospital.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase