GMP Manufacturing Associate

Precigen, Inc•Germantown, MD

3d•$70,000 - $85,000•Onsite

About The Position

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.

Requirements

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)

Nice To Haves

Prior cell culture and/or purification experience in a GMP facility is preferred.
Prior Tangential Flow Filtration (TFF) experience is preferred.

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.
This position requires occasional weekend and shift work.
Other duties as assigned.