Tech Transfer Lead
Triumvira Immunologics Inc. is recruiting for the newly created role of Technical Transfer Lead. Qualified inpiduals need to be inspired to support the development of therapeutics and/or life science products to support patients in need. We aspire to improve the quality of life through our efforts. In return we provide development and support to enhance your career using cutting edge T cell technology.
This will support the efficient transfer of manufacturing and quality control processes from the MSAT and Quality Assurance teams to the Manufacturing Operations throughout the lifecycle of a product. Prepare tech transfer documentation including material, equipment, and process specifications. Proactively collect information from subject matter experts in the MSAT team and at vendors and prepare the documentation required to start manufacturing and QC operations. The Tech transfer lead will provide leadership and guidance to all involved parties and oversee all tech transfer activities and documentation.
• Lead robust process tech transfer plans, detailed process flow diagrams (PFD), bill of materials (BOM), manufacturing batch records, and campaign summary reports for various modalities of allogeneic and autologous cell and gene therapies
• Support smooth and efficient tech transfer of processes and analytical methods from development groups to the Manufacturing Team.
• Develop/Optimize SOPs and Batch Records to enable implementation of the process in cGMP manufacturing environments.
• Work with internal and external subject matter experts to gather technical information about materials, equipment, and processes.
• Work with cross-functional teams to track action items and ensure timely completion of all tech transfer enabling activities.
• Contribute to cell therapy process development laboratory activities
• Participate in generation of scientific and technical reports and applicable regulatory filings
• Continual interaction & involvement in technical transfer activities throughout product life cycle.
• Identify and implement potential process improvements in conjunction with manufacturing and MSAT team.
• Support management by tracking and reporting progress on GMP readiness and tech transfer document completion.
• Assist in the preparation of user requirements, material specifications, system impact assessments, and process specifications.
• Support investigations and continuous improvement project related to materials, equipment and processes.
• Maintain up-to-date knowledge of US, EU and other applicable GXPs guidance documents along with necessary licensing/certifying agency requirements.
• Other job functions as assigned.
• Experience in cell and gene therapy practices and regulations, inclusive of cGMP operations
• Comfortable working in a fast-paced environment with broad responsibilities and opportunities
• Master’s degree, in life sciences, chemistry, engineering, or related field plus three years relevant work experience.
• Three years of relevant work experience in cell therapy, with demonstrated achievements and progressive responsibilities.
• Strong organizational and communication skills.
• Self-motivated with a sound work ethic, initiative, and the ability to multi-task.
• Flexibility to change project objectives quickly and enthusiastically.
• Proficient in written and oral communication, as well as the ability to work well independently and as part of a team.
• Fundamental knowledge of the manufacturing environment for cell therapies
• Functional knowledge of analytical (QC) procedures for cell therapies
• Familiarity with cell therapy manufacturing equipment and materials.
• Strong computer skills with proficiency in Microsoft Office programs, databases and SharePoint functionality
• Some evening and/or weekend work is required.