Agenus

  • Manufacturing Associate

    Job Locations US-CA-Berkeley
    Job ID
    2018-1382
    Category
    Manufacturing
  • Overview

    A Manufacturing Associate (MA) will support the clinical development of Mab’s at Agenus West – Process and Manufacturing Sciences Department.  Work will focus on the development of large scale production processes under cGMP compliance.  MAs will be required to work in both the process development labs and the GMP controlled labs.  Work includes a flexible schedule that will allow the MA to be “hands on” sampling, trouble shooting, and controlling USP and DSP development/production.  This position will actively participate in the technology transfer between Process Development and Manufacturing Sciences.

    Responsibilities

    ESSENTIAL DUTIES (responsibilities included but not limited to):

    • Attention to detail, good record keeping and documentation.
    • The ability to execute work under minimal to no supervision.
    • Coordination/collaboration with other departments (includes: Process Development, Quality, Facilities, Procurement, etc.)
    • Experience and knowledge of cGMPs
    • Contribution and participation in other assignments/projects include: report writing, data analysis, experiment/validation execution, data compilation/summarization.
    • Under moderate supervision, participates in technical procedures related to the development and/or scale-up of pharmaceutical production processes. Support upstream/downstream development activities.
    • Perform/support process development experiments according to protocols defined by research staff
    • Execute engineering and clinical GxP production processes
    • Record and document procedures with detail and accuracy. This includes batch records, training records, logbooks, standard operating procedures (SOPs) and validation protocols.
    • Weigh and prepare culture media, buffers, and solutions.
    • Set-up, prepare, and operate clinical manufacturing equipment/lab ware/assemblies (including: filtration skids, chromatography skids, Bioreactors, autoclave/sterilizer, etc.) in accordance with cGMP
    • Monitor cell culture and purification operations (including trouble-shooting and diagnosis of instruments, equipment, process, etc.)
    • Sample solutions and perform analytical assays (including cell counts, pH, conductivity, etc.)
    • Perform technical training (including hands-on and class based training)
    • Identify and implement equipment and process improvements.
    • Create and revise standard operating procedures, batch records, specifications, etc.
    • Execute quality systems (includes: CWO, CCR, ECR, deviations, CAPA, etc.)
    • Plant cleaning (including floors, benches, bioreactors, equipment, etc.) waste disposal, lean manufacturing and good manufacturing practices (GMP)/compliance.
    • Execution of other tasks/assignments/projects as given by Manufacturing Sciences Management
    • Flexible Schedule
    • Accessibility via Cell Phone
    • Work a nonstandard schedule
    • Work evening or night shift hours as required
    • Provide coverage/support for other positions, functions, and departments

    Qualifications

    MINIMUM QUALIFICATIONS/REQUIREMENTS:

    • At least 2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, or a related field from a four-year college or university; and 4 to 6 years of related experience; or 6 to 10 years of experience and/or training or equivalent combination of education and experience.
    • Science related training or courses
    • Skills in Biological/Chemical Sciences, Math and English.
    • Knowledge of cGMP’s
    • Able to work independently as part of a team.

    • Effective organizational and solid record-keeping skills
    • Effective communication skills

    PREFERRED QUALIFICATIONS/REQUIREMENTS:

    • BS Degree

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