Agenus

Manufacturing Associate

US-CA-Berkeley
Job ID
2017-1237
Category
Manufacturing

Overview

A Senior 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.  Senior 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 senior 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.
  • Provide mentorship, training and leadership to junior staff members.
  • 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.
  • Coordinate and collaborate with vendors.
  • 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.

SCOPE & IMPACT:

  • A senior MA will be required to make recommendations based on analysis and present to supervisor for final decision.

OTHER COMMENTS/REQUIREMENTS NOT PREVIOUSLY NOTED:

  • 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 or lead a team on assigned projects.
  • Effective organizational and solid record-keeping skills
  • Effective communication skills

PREFERRED QUALIFICATIONS/REQUIREMENTS:

  • BS Degree

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