Turnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone’s innovative TIL therapy is based upon the identification, selection, and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TILs that have demonstrated objective responses only in limited tumor types. Turnstone’s most advanced program, TIDAL-01, is currently being evaluated in two Phase 1 studies in patients with melanoma, breast cancer and colorectal cancer, and the Company is also actively advancing its preclinical pipeline programs including TIDAL-02, its next Selected TIL program, and its TIDAL-01 and viral immunotherapy combination program.

Position Overview:

Turnstone Bio is seeking a driven and experienced Senior Manager to support the Manufacturing Operations Team.  This successful candidate will oversee Turnstone Bios Manufacturing network by providing technical and operational support of the TIDAL-01 process at our external CDMOs, such as: leading or supporting scheduling end to end patient journey, operational and/or process readiness, and improvements, The successful candidate should be detail oriented and enjoy working in a dynamic high-paced environment to deliver innovative therapies to patients in need.

This is a key position requiring routine interaction with Clinical Operations, External Manufacturing Operations, MSAT, PD, Quality Assurance, and Supply Chain. The role will provide support Turnstone Bio Manufacturing network, including the Ottawa, CAN and San Diego, California (TBio sites), and External MFG partners. As such, flexibility to provide remote support, as necessary, for manufacturing operations is required. In addition, this candidate will support the evaluation of new or future external and internal manufacturing capabilities.

Primary Responsibilities (include but not limited to):

  • Interact with TBio leadership to influence strategic and technical guidance on ongoing clinical production internally, and at External MFG partners 
  • Establish and manage business processes to drive process improvements using data-driven results (e.g. scheduling enhancements and optimization, MFG process an operational improvements)
  • Coordinate with upstream Clinical Operations and downstream Clinical Manufacturing teams, ensuring clear flow of communication across the manufacturing lifecycle
  • Collaborate with Process Development teams on implementation of process optimizations, and new technology, critical reagents, and materials
  • Provide on-site/remote Subject Matter Expert (SME) support for GMP MFG operations.
  • Leads CMO/CDMO evaluations to support ramp up
  • Acts as MFG Ops Person-in-Plant (PiP) to oversee all aspects of operations at CMOs/CDMOs and works with CMOs/CDMOs to implement improvements and necessary corrections to ensure compliant CGMP operations in line with any regulatory filings and product specifications.  
  • Tracks and maintains budget related to activities at the CMO/CDMO and is responsible for ensuring activities complete per project timelines.  
  • Manage Materials Management relationship, ensures material kitting process is defined for TIDAL-01, and supports inventory consolidation (consumption reports in SAP vs. actual usage) 
  • Champions business and process improvements for material ingress in the MFG suites 
  • Leads and supports operations (technical, quality, supply chain, manufacturing, QC, packaging and logistics) activities associated with the manufacture of products at CMOs/CDMOs and partners.  
  • Partners with CMO/CDMO to ensure successful manufacture of products required for clinical supply, process validation, and/or commercial supply.  
  • Provides guidance for equipment and support process validation activities with MSAT at the contract manufacturing facility. Provides technical/operational input/feedback to MSA and, Process Development for defining the critical parameters of new and existing processes.  
  • Collaborates with manufacturing quality partner and internal quality teams to develop processes and systems that enable compliant, successful technology transfers, operation, and lifecycle management of CGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met.  
  • Drives timely decisions and facilitates active communication and information flow between contract manufacturer and Turnstone Biologics team members.  
  • Authors technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.  
  • Identifies and drives process and operational optimization initiatives and addresses opportunities for efficiency, capacity improvements, and cost reduction.  
  • Partners with MSAT, Process Development, and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements.  
  • Owns and drives change controls to make necessary changes to CGMP processes.  

 

 Experience & Qualifications/Requirements:

  • Bachelor’s degree, in life sciences, engineering or related field and 8 or more years of industry experience; Masters degree with 8+ or more years of experience; PhD and 3-5 years of experience
  • Enjoy working in a fast-paced environment
  • Experience in cell or gene therapies preferred



Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.  We thank all applicants for their interest, however, only those selected will be invited for an interview.


 

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