Upstream Tech Transfer, Scientist
📋 Role Overview & Responsibilities
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 developmenttechnology transfer activities for viral vector pilot and GMP manufacturing campaigns. Candidates may have experience in cell culture, viral vector production, scale up, Tech Transfer, GxPdocumentation, 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 scaleSupport Process Fit to Plant evaluationAuthor protocols to support pilot-scale manufacturing campaignProvide planning and logistics support for pilot scale executionProvide hands-on and technical support during execution of pilot-scale executionAuthor 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 proficiencyHands-on experience with common upstream pilot equipment and operations (i.e., SingleUse Bioreactors, adherent and suspension vector processes) and ability to train junior staffAbility to follow procedures with attention to detail, and successfully execute experiments at the benchComfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing prioritiesDemonstrated ability to maintain detailed execution records and perform data analysisKnowledge or experience with gene therapy manufacturing in the biotech industry is preferredStrong communication skills (e.g., clear and concise) and a team playerStrong time and project management skillsCritical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolutionSelf-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environmentTakes ownership of the assigned project, consulting with management and peersAble 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.
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This position is located in King of Prussia, PA with potential relocation and sponsorship assistance depending on candidate qualifications.
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