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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

Director/Senior Director, Manufacturing Sciences and Technology

 Key responsibilities:  

 

Director, Manufacturing Sciences and Technology 

• Lead at-scale development of Adicet’s CAR T products based on the γδ T cell platform  

• Project manager and subject matter expert during tech transfer and clinical manufacturing at external CMO with independent oversight of materials, training program, and operator readiness  

• Author and/or revise batch records and supporting documentation for use in cGMP manufacturing at both external CMOs and for internal manufacturing  

• Act as PIP when required  

• Identify and evaluate novel technologies for automated, commercial-scale cGMP manufacturing (e.g. electroporation, bioreactor, cell separation, centrifugation, and formulation/fill/finish systems)  

• Support onboarding of new cGMP manufacturing personnel by providing training on processes and equipment in non-cGMP environment  

• Supervise the execution of at-scale CMC studies on pipeline products, present data, and advise on manufacturability bottlenecks towards IND filing and cGMP manufacturing  

• Supervise execution and analysis of flow cytometric assays for T cell product characterization  

• Authorship of manufacturing process development section of CMC regulatory filings  

• Document risk assessments and gap analysis of process to identify points of improvement  

• Ensure complete and accurate data entry for MS&T team members including review and approval of electronic notebook entries and aggregate data files 

 

Senior Director, Manufacturing Sciences and Technology 

• All of the above 

• Design studies and develop strategy for process validation including identification of NORs, CPPs, CQAs 

• Author FMEAs and risk assessments for late-stage CMC development 

• Delegate oversight of day-to-day operations by developing internal managerial resources 

• Lead evolution of QTPP with process and manufacturing experience 

 

Qualifications: 

 

Director, Manufacturing Sciences and Technology 

• PhD in life sciences or biotech engineering and at least six years of relevant experience, with at least two years people management experience. 

• Experience with cell therapy tech transfer including to external CMOs  

• Has been responsible for the development and ultimately, successful clinical manufacture, of a cell therapy process  

• Expertise with use and troubleshooting of common cell therapy bioprocess equipment  

• Expertise with design and analysis of T cell flow cytometry assays  

• Strong leadership skills, ability to communicate and partner well with all levels of staff, to lead and motivate with emphasis on continuous improvement  

• Proven ability to troubleshoot and resolve issues  

• Expertise with Microsoft