GMP Operator

Highly Competitive
  1. Permanent
  2. Validation
  3. United States
Fargo, North Dakota
Posting date: 26 Mar 2019

ProClinical is advertising a vacancy for a HIV Operations Associate position with a leading biotechnologycompany. The organization prides itself on its specialisation in DNA production, Protein Production, and Antibody Generation. Based in the company's North Dakota office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

  • Overseeing segregation, line clearance, and cleaning of GMP production areas.
  • Planning and submitting inventory requisitions.
  • Planning and preparing for production events including preparing of processing plan memos.
  • Coordinating production events with buffer preparation operators.
  • Executing GMP projects with either upstream or downstream tasks and all special considerations associated.
  • Upstream tasks include:
    • Transformation
    • Subculture
    • Cell Banking
    • Shake Flask Growth and Harvest
    • Wave Growth and Harvest
    • Fermentation
    • Media Fill Events
    • Final Formulation
    • Filtration and Dispensation
  • Downstream tasks including:
    • Project Set-up
    • Lysis
    • Anion Exchange Chromatography
    • Hydrophobic Interaction Chromatography (void and enrichment)
    • Thiophilic Absorption Chromatography
    • Diafiltration
    • Small Scale Processing
    • Linearization
  • Completing all documentation associated with GMP projects.
  • Coordinating and sampling submission with Quality Control.
  • Packaging final material prior to shipments.
  • Calibrating equipment and overseeing/implementing preventative maintenance.
  • Writing Manufacturing Summary Reports after project completion.
  • Maintaining personnel training record.
  • Assisting with assembly and segregation of all consumables and equipment resources for GMP production runs.
  • Participating and supporting internal audit program by providing requested information and responding to findings presented in the audit report.
  • Communicating the status of operations, process issues, and safety and maintenance issues to appropriate area management.
  • Following SOP's and adhering to regulatory expectations.
  • Completing and maintaining of GMP Bill of Materials for GMP projects.
  • Completing Metrics Tracking.

Skills and Requirements:

  • Bachelor's Degree in Life Sciences (Biology, Chemistry, Biotech) preferred.
  • High School Diploma required.
  • 2 years of technical laboratory experience in a regulated industry required
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at 312-270-1613 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.