Manufacturing Associate I/II - Purification JPOD

Just-Evotec Biologics is seeking a highly motivated Purification Manufacturing Associate that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for the commercial manufacturing of mammalian cell-based biotherapeutics under cGMP conditions. Manufacturing Associates are expected to execute process recipes, monitor equipment and processes, perform basic tasks, including sampling, and routine maintenance of lab equipment. Associates will also assist in media and buffer compounding. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.

Must be willing to work either the second (swing) or third (night) shifts as required by production schedule

Responsibilities:

• Perform and monitor critical processes (i.e., column packing, capture and polishing chromatography steps, viral inactivation, viral filtration, and UF/DF operations)

• Supporting the introduction of new products and technologies into the facility

• Initiating non-conformances (NC)

• Draft and revise Manufacturing Procedures and Standard Operating Procedures, as necessary

• Execution of Electronic Batch Records (EBR) using Manufacturing Execution System (MES)

• Support operations of glasswasher and autoclave

• Perform other duties as assigned

Educational Requirements:

• Bachelor’s degree in Science or Engineering; or

• Associate’s degree in science-related area and relevant experience; or

• High school diploma or GED and 5 or more years of relevant experience.

Qualification Requirements:

• Candidate must possess strong focus on quality and attention to detail

• Possess effective task/time management organizational skills

• Capacity to develop solutions to technical issues of moderate scope

• Ability to organize, analyze/interpret, and effectively communicate individual results

• Motivated, self-starter with strong mechanical aptitude

• Good interpersonal, team, and communication skills are a must

• Excellent oral and written communication skills