Sr. Manufacturing Associate - Cell Culture, J.POD

Location
Redmond, WA, United States
Posted
Oct 28, 2020
Ref
319644137
Hotbed
BioForest
Required Education
Masters Degree/MBA
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

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers