GMP Gene Therapy Manufacturing Associate II

General Description

The GMP Gene Manufacturing Associate I/II will be part of a dynamic team responsible for the cGMP manufacturing of clinical and commercial adenovector products. The role requires a professional with meticulous attention to detail and a proactive approach to improving processes.

Duties and Responsibilities

• Perform manufacturing for clinical and commercial materials in a GMP setting
• Execute Master Batch Records (MBR) under current Good Manufacturing Practices (cGMPs)
• Support the development and implementation of standard operating procedures (SOPs), MBRs, and deviation management
• Participate in and facilitate technology transfer processes
• Support routine cleaning and changeover procedures for clean room suites and equipment
• Work collaboratively in a team-based environment to complete production tasks
• Adhere to all safety and regulatory requirements while performing job functions

Education and Experience

• Bachelor's degree or master's degree in biology, biomedical science, or life science
• Minimum of one to three (1 – 3) years in a GMP environment required
• Aseptic technique experience is required
• Prior cell culture experience in a GMP facility is preferred
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs)

Desired Key Competencies

• Comfortable in a fast-paced company environment and able to adjust workload based on changing priorities
• Self-motivated and willing to accept temporary responsibilities outside of the initial job description
• Positive interpersonal skills
• Outstanding knowledge and ability to apply scientific principles to solve operational and routine production tasks
• Ability to troubleshoot unit operations
• Self-organizer with meticulous hands-on habits and keen attention to detail
• Ability to manage multiple and varied tasks and prioritize workload
• Prior Tangential Flow Filtration (TFF) experience is preferred