GMP Gene Therapy Manufacturing Associate II

Job Description

Job Description

GENERAL DESCRIPTION:

GMP Gene Manufacturing Associate I/II will require a professional who thrives in a dynamic team environment, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will perform a broad range of tasks in the cGMP manufacturing of clinical and commercial adenovector products. Prior experience in GMP manufacturing and operation of GMP process equipment are required.

DUTIES AND RESPONSIBILITIES:

• Perform manufacturing for clinical and commercial materials in GMP setting, including, but not limited to:

• Assembling raw materials
• Execute Master Batch Records (MBR) under current Good Manufacturing Practices (cGMPs.)
• Following and assisting in the development of specific standard operating procedures (SOP), MBRs, deviations and summary reports for manufacturing
• Support initiation and closure of deviations
• Support routine cleaning and changeover procedures for clean room suites and equipment
• Participating in and facilitating technology transfer

• Work in a team based, cross-functional environment to complete production tasks.
• Adhere to all safety and regulatory requirements while performing job functions.

EDUCATION AND EXPERIENCE:

• Bachelor's degree or master 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 upon changing priorities.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
• Positive interpersonal skills.
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Ability to troubleshoot unit operations.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Ability to manage multiple and varied tasks and prioritize workload
• Prior Tangential Flow Filtration (TFF) experience is preferred.

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