Director/Senior Director, Manufacturing Sciences and Technology

Adicet Bio•Redwood City, CA

2d•Hybrid

About The Position

JOIN US! 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 K ey 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

Requirements

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 Office suite, JMP, Prism, FlowJo, electronic lab notebook software)
Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams
PhD in life sciences or biotech engineering and at least eight years of relevant experience, with at least three years people management experience.
Phase 2/pivotal CMC development and process validation experience required.

Responsibilities

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
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

Benefits

annual cash bonus
long-term incentives (equity)
Employee Stock Purchase Plan (ESPP)
401(k) with ROTH and a 4.5% Company match
comprehensive health plans (medical, dental, vision, etc.)
Flexible Health and Commuter Spending Accounts (FSA)
company matched Health Savings Account (HSA)
life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs
generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave
onsite gym and various other fitness options
onsite parking with electric vehicle charging stations and free shuttle (Caltrain)
company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms