Manufacturing Sr. Specialist - J.POD

Location
Redmond, WA, United States
Posted
Oct 03, 2020
Ref
2135134889
Hotbed
BioForest
Required Education
Masters Degree/MBA
Position Type
Full time
Just-Evotec Biologics is seeking a highly motivated Manufacturing Sr. 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. The Manufacturing Sr. Specialist will lead a team of Mfg. Specialists expected to execute start-up activities, as well as support clinical and commercial manufacturing operations post start-up.

Responsibilities:

Start-up activities include, but are not limited to:
    • Execution of equipment and process validation
    • Authorship of SOP's and/or Batch Records or Technical Reports
    • Lead Risk Assessments
    • Act as the MES Super User
    • Provide training as the SME/Lead Trainer.

Ongoing support of GMP operations include but are not limited to:
    • Translating Process Transfer Documents into Batch Records for NPI's
    • Create, review and update batch records, forms, and Standard Operating Procedures, as necessary
    • Apply capacity model data and scheduling oversight
    • Deliver on operational excellence continuous improvement
    • Lead 6S, Kaizen Events, Critique Analysis, Value stream mapping sessions as needed
    • 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
    • Triage in-process equipment troubleshooting
    • 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 and be the manufacturing representative for the governance of platform changes.
    • Participation in client and regulatory agency audits

    Perform other duties as assigned

    Basic Qualifications:
    • Master's degree and 6 years of Manufacturing & Operations experience Or
    • Bachelor's degree and 8 years of Manufacturing & Operations experience Or
    • Associate's degree and 15 years of Manufacturing & Operations experience Or
    • High school diploma / GED and 20 years of Manufacturing & Operations experience

    Preferred Requirements:
    • Technical lead and/or leadership/supervisory/managerial experience
    • 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
    • Experience with finite scheduling tools and allocation of resources and equipment
    • Experience with GMP Quality Systems, such as, 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