Process Validation Specialist

Scope

Support process validation for manual RNA and cellular manufacturing for autologous dendritic cell immunotherapies. Support comparability demonstration efforts for process improvements. Support continuous process monitoring and trending efforts as well as aseptic process validation, cleaning validation, and other required studies for the process (e.g., leachables/extractables, etc.).

Duties

  • Process Validation – Assist in execution of process validation in accordance with policies and procedures. Support process validation and comparability efforts, including aseptic process validation, cleaning validation, process trending reports, process risk assessments, buffer hold time studies, and required protocol generation, execution, and final reports for these activities. Support execution of these activities, including completion of validation deviations. Assist in developing plans for leachables/extractables assessments and cleaning validation studies. Assess new regulations, guidances, and industry practices on process validation to assist in the development or revision of the program to ensure compliance. Support the completion of statistical process analysis. Work collaboratively with process experts to support process validation efforts and with Operations and Quality to generate and execute protocols.
  • MS&T – Support evaluations of proposed process changes and assessing impact to process validation. Assist in technical assessments for process-related investigations.
  • Confidentiality –Ensure that information and documentation pertaining to Argos Therapeutics, Inc. is treated as confidential information and handled appropriately as confidential information.
  • Safety – Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of co-workers with all safety policies and procedures at all times.
  • Other duties as required.

Qualifications:

  • Requires a BS degree in a scientific or engineering discipline with 5+ years related experience or a MS degree in a scientific or engineering discipline with 3+ years related experience
  • Biologics process validation experience is required. Comparability protocol experience is preferred.
  • Experience with molecular biology and cellular therapy products is preferred.
  • Experience with SAS, JMP, or similar statistical software is required.
  • Familiarity with all relevant and current FDA, EU and associated process validation guidances including ICH Q8, Q9, and Q10 is required.
  • Experience preparing PV-related regulatory submissions and presenting PV documentation to regulatory agencies is a plus.
  • Good interpersonal and communication skills are required.
  • Excellent decision making and creative problem solving skills.
  • Flexibility on work schedules and duties.
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