Manufacturing Coordinator - J.POD

Just-Evotec Biologics is seeking a highly motivated Manufacturing Coordinator that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for facilitating and coordinating activities in support of the commercial manufacturing of mammalian cell-based biotherapeutics under cGMP conditions. Manufacturing Coordinators are initially expected to assist in commissioning, validation, and other start-up activities. Post start-up activities, the coordinators are expected to support GMP manufacturing as described below.

Responsibilities:

• This team member will be responsible for the support of commercial manufacturing of mammalian cell-based biotherapeutics under cGMP conditions.
• Maintains and distributes material shortage list to the production, planning, and procurement departments.
• Monitors process area inventory levels to ensure production continuity.
• Manufacturing Coordinators will routinely interface with other functional groups, including Facilities, Engineering, Quality Assurance, and Quality Control.
• Will ensure equipment maintenance and repairs are completed and all equipment is available for use when needed.
• Coordinates with Manufacturing Scheduler to schedule equipment downtime for maintenance, minimizing manufacturing disruptions.
• Primary contact for contract facility cleaning staff. Ensures facility cleanings occur as required and contract staff are trained per effective Standard Operating Procedures.
• Maintains and coordinates punch list items within the manufacturing space during facility shutdowns.
• Administers inventory levels within the lean manufacturing environment.
• Will maintain the plant Kanban system and will ensure required supplies are stocked and available for Manufacturing Operations Staff
• Interface with gowning supplier to ensure stock of cleanroom gowning supplies is always maintained.
• The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.
• 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:

• Candidate must possess strong focus on quality and attention to detail.
• Possess a working knowledge of spreadsheets, database, and word processing applications.
• Proven knowledge of cGMP requirements to ensure compliance.
• Motivated, self-starter with strong time management and organizational skills.
• Ability to organize, analyze/interpret, and effectively communicate data and results.
• Good interpersonal, team, and communication skills.
• Excellent oral and written communication skill.

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 200 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