Senior Manufacturing Associate – J.POD Cell Culture 

Location
Redmond, WA
Posted
Oct 04, 2021
Ref
REQ-03715
Hotbed
BioForest
Required Education
High School or equivalent
Position Type
Full time

Just-Evotec Biologics is seeking a highly motivated Senior 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. Senior Manufacturing Associates are initially expected to execute commissioning, validation, and other start-up activities. Post start-up activities, they are expected to support upstream manufacturing operations.

Responsibilities:
•Draft and revise Manufacturing Procedures and Standard Operating Procedures, as necessary
•Supporting the introduction of new products and technologies into the facility
•Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
•Perform and monitor critical processes (i.e., SUB batch, inoculations, perfusion, and harvest operations)
•Train other personnel on equipment operation
•Available to work various shifts (day, swing, graves, weekends, holidays, as dictated by the production schedule
•Perform other duties as assigned

Basic Qualifications:
•Master’s degree; or
•Bachelor’s degree and 3 years of Manufacturing & Operations experience; or
•Associate’s degree and 5 years of Manufacturing & Operations experience; or
•High school diploma / GED and 8 years of Manufacturing & Operations experience

Preferred Requirements:
•Single use technology experience
•Capacity to develop solutions to technical issues of moderate scope
•Proven knowledge of cGMP requirements to ensure compliance
•Experience in upstream operations required for the manufacture of biotherapeutics
•Candidate must possess strong focus on quality and attention to detail
•Ability to organize, analyze/interpret, and effectively communicate data and results
•Motivated, self-starter with strong mechanical aptitude
•Good interpersonal, team, and communication skills
•Basic troubleshooting skills on Manufacturing equipment including single use equipment
•Experience with Delta V/MES
•Experience with lab equipment/testing

Worker