• Full Time (Salaried)
  • , CA

Company:  Confidential

Job Title: Manufacturing Associate I/II

Job Number: 34330

Location: , CA

Job Description

This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

Responsibilities

  • Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
  • Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
  • Compiling data for documentation of test procedures and reporting abnormalities
  • Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
  • Authoring, revising and updating standard operating procedures using the document change system
  • Maintaining broad knowledge of state-of-the-art principles and theories
  • Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
  • Preparing technical summaries, protocols and reports
  • Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
  • Performing special manufacturing and development projects

Required Skills

  • Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
  • 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
  • Laboratory experience in mammalian tissue culture is required
  • Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
  • Exceptional communication and interpersonal skills
  • Excellent organizational skills and attention to detail
  • Ability to work in a dynamic environment
  • Basic molecular biological and flow cytometry skills are preferred
  • Adaptable/flexible with work schedule with an ability to multi-task and prioritize work 
  • From time-to-time extended hours may be required with or without notice, dependent on the work needed

Salary: 70-82k

 

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