Manufacturing Specialist - J.POD

Just-Evotec Biologics is seeking a highly motivated Manufacturing Specialist that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of commercial manufacturing of mammalian cell-based biotherapeutics while ensuring cGMP compliance. Manufacturing Specialist are initially expected to execute commissioning, validation, and other start-up activities. Post start-up activities, the specialists are expected to support manufacturing operations.

Responsibilities:

• Provide manufacturing quality system support (deviations - root cause analysis, corrective and preventive actions, change controls) for all plant operations, as necessary
• Execute manufacturing activities according to cGMP guidelines, ensuring batch execution, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution
• Implement compliance and drive towards continuous improvement in the plant and track progress on a plant level
• Lead and/or represent manufacturing on functional sub-teams where appropriate
• Create, review and update batch records, forms, and Standard Operating Procedures, as necessary
• Perform other duties as assigned

Basic Qualifications:

• Master's degree and 3 years of Manufacturing & Operations experience

OR

• Bachelor's degree and 5 years of Manufacturing & Operations experience

OR

• Associate's degree and 10 years of Manufacturing & Operations experience

OR

• High school diploma / GED and 12 years of Manufacturing & Operations experience

Preferred Requirements:

• Experience in GMP Tech Support roles, GMP operations or process development
• Extensive technical knowledge of upstream and/or downstream processing and broad understanding of related disciplinary areas
• Ability to organize, analyze/interpret, and effectively communicate data and results with internal and external colleagues in both presentation and technical writing forms
• Ability to design and execute a technical study with minimal guidance
• Ability to coach, mentor, and/or cross train colleagues
• Recognized technical mastery of disposable manufacturing technologies at commercial scale
• Participation in client and regulatory agency audits
• Experience with finite scheduling tools and allocation of resources and equipment
• Change control, NC/CAPA, and deviations
• Knowledge of Manufacturing Execution System (MES)
• Fundamental understanding and basic operation of process automation (DeltaV)
• Good interpersonal, team, and communication skills

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