GMP Manufacturing Associate

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Full-time Regular Associate - STAFF Germantown, MD, US

Salary Range: $70,000.00 To $85,000.00 Annually

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.

• Perform manufacturing for clinical and commercial materials in GMP setting, including, but not limited to:
• Assembling raw materials
• Execute Master Batch Records (M ) 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.
• This position requires occasional weekend and shift work.
• Other duties as assigned.

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

• 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.