Director – Manufacturing Operations  | Seattle, WA

Just-Evotec Biologics is seeking a highly motivated Director, Manufacturing Operations, that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to lead a group of manufacturing staff in the execution of early stage (Phase 1 and 2) GMP clinical manufacturing operations, including cell culture and purification, at our J.Plant Facility in Seattle WA. In additional to early phase clinical manufacturing, the group is also responsible for the developing and operationalizing advanced and intensified processing technologies, most notably the advancement of end-to-end continuous biologics manufacturing.

This position requires on-the-floor presence and leadership, focused specifically on day-to-day operations using disposable-based manufacturing technologies and ensuring cGMP compliance. Additional job responsibilities may include troubleshooting and/or providing technical expertise, plant forecast scheduling, ensuring staff training compliance, executing against approved written procedures, reviewing and approving GMP documentation, participating in commissioning and validation activities, maintaining required cGMP compliant systems, and providing support for quality, regulatory, and site inspections.

Educational Requirements:

  • Bachelor’s degree in biological or engineering science with 12+ years relevant experience

Qualification Requirements:

  • Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
  • Working knowledge of cGMP requirements to ensure compliance
  • Previous experience managing the activities of both individuals and large groups of staff
  • In-depth knowledge of equipment, operations, and engineering principles
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Working knowledge of US FDA CFRs and European EMA, including ICH guidelines
  • Experienced in the use of electronic systems such as Quality Management Systems.
  • Understanding of process automation (e.g. DeltaV) and BAS systems
  • Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
  • Applies knowledge and expertise to solve complex technical problems
  • Significant contributor to multi-disciplinary teams at the functional level
  • Mentors and provides technical advice to individuals within the team

 

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

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