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Jobs or company...

Drug Substance Process Engineer

  • Full Time, onsite
  • GForce Life Sciences
  • United States, United States of America
Salary undisclosed
Checking job availability...
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Consultant, Senior Engineer-Biologics Drug Substance, Pharmaceuticals

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Senior Engineer, Biologics Drug Substance who will be responsible for supporting Biologics Drug Substance upstream manufacturing and technology transfer to clinical and commercial CDMOs.

Duties / Expectations of Role

  • Perform process technology transfer between external clients or Process Development and Drug Substance Manufacturing.
  • Author and review documents including batch production records, protocols, tech transfer reports, bill of materials, process descriptions, project reports, user specifications, and summary reports.
  • Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
  • Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
  • Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.

Basic Qualifications

  • A degree in chemistry, biochemistry, chemical engineering, or biology and relevant practical experience working in an cGMP regulated environment.
  • Bachelor degree with 10+ years of work experience, or Master’s degree with 7+ years of work experience, or PhD degree with 5+ years of work experience.
  • Experience in performing technical transfer of processes and scale-up.
  • Experience with cell culture process at Manufacturing scale.
  • Ability to travel up to 25%.

Term & Start

  • 12 month contract, open to 12+ month extension
  • 2 Video Interviews - Start 2 weeks from an offer
  • Full time, 40 hours/week
  • Remote – Able to work EST hours
  • Benefits available (Medical, Dental, Vision, 401k after 1 year)
  • Pay starting at $120,000+ (based on experience)

Consultant, Senior Engineer-Biologics Drug Substance, Pharmaceuticals

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Senior Engineer, Biologics Drug Substance who will be responsible for supporting Biologics Drug Substance upstream manufacturing and technology transfer to clinical and commercial CDMOs.

Duties / Expectations of Role

  • Perform process technology transfer between external clients or Process Development and Drug Substance Manufacturing.
  • Author and review documents including batch production records, protocols, tech transfer reports, bill of materials, process descriptions, project reports, user specifications, and summary reports.
  • Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
  • Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
  • Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.

Basic Qualifications

  • A degree in chemistry, biochemistry, chemical engineering, or biology and relevant practical experience working in an cGMP regulated environment.
  • Bachelor degree with 10+ years of work experience, or Master’s degree with 7+ years of work experience, or PhD degree with 5+ years of work experience.
  • Experience in performing technical transfer of processes and scale-up.
  • Experience with cell culture process at Manufacturing scale.
  • Ability to travel up to 25%.

Term & Start

  • 12 month contract, open to 12+ month extension
  • 2 Video Interviews - Start 2 weeks from an offer
  • Full time, 40 hours/week
  • Remote – Able to work EST hours
  • Benefits available (Medical, Dental, Vision, 401k after 1 year)
  • Pay starting at $120,000+ (based on experience)