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Upstream Tech Transfer Scientist

3 months ago

King of Prussia, United States SK pharmteco Full time

Position: Upstream Tech Transfer, Scientist


Location: King of Prussia (onsite)


Company: Sk Pharmteco


The Scientist, Upstream Tech Transfer (PD/Tech Transfer) will report to the Associate Director of Tech Transfer and will have responsibilities supporting the upstream process development

technology transfer activities for viral vector pilot and GMP manufacturing campaigns. Candidates may have experience in cell culture, viral vector production, scale up, Tech Transfer, GxP

documentation, and technical report authoring and review. Experience in project management and Microsoft visio is a plus, but not required.


Responsibilities:

  • Work closely with process development scientist and/or client in process knowledge transfer to scale-up process for pilot scale
  • Support Process Fit to Plant evaluation
  • Author protocols to support pilot-scale manufacturing campaign
  • Provide planning and logistics support for pilot scale execution
  • Provide hands-on and technical support during execution of pilot-scale execution
  • Author knowledge transfer documentation for GMP manufacture (e.g., bill ofnmaterials, process flow diagrams, and sample plans)
  • Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
  • Collaborate with process development scientists and manufacturing to establish technology transfer plan and perform technical risk assessment for the product/process introduction to the GMP facility.
  • Provide technical support for process-related issues or investigations.
  • Provide scientific/engineering support for technology transfer and manufacturing of viral vectors


Requirements:

  • BS (4+ years experience) or MS (2+) in Chemical Engineering, Biology, or similar life sciences degree with experience in upstream technologies and demonstrated laboratory proficiency
  • Hands-on experience with common upstream pilot equipment and operations (i.e., Single
  • Use Bioreactors, adherent and suspension vector processes) and ability to train junior staff
  • Ability to follow procedures with attention to detail, and successfully execute experiments at the bench
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Demonstrated ability to maintain detailed execution records and perform data analysis
  • Knowledge or experience with gene therapy manufacturing in the biotech industry is preferred
  • Strong communication skills (e.g., clear and concise) and a team player
  • Strong time and project management skills
  • Critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
  • Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Takes ownership of the assigned project, consulting with management and peers
  • Able to understand and interpret data/information and its practical application


Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 30 pounds at times.
  • Standing/working in a lab setting for more than (4) hours when needed.