GMP Manufacturing Associate

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 (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.

EDUCATION AND EXPERIENCE:

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.

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.

EOE MFDV