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.

At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

Our teamwork with an unrelenting sense of urgency to fulfill our mission. Our decision-making is driven by bold science and our therapeutics are designed with the patient at the forefront of our thoughts.

Job Description

Turnstone Biologics is seeking a driven and experienced Sr. Process Engineer/ Principal Specialist to support the Manufacturing Science & Technology Team (MSAT). This successful candidate will support the Turnstone manufacturing network by providing technical and scientific support of the TIDAL-01 operations process, such as: leading or supporting technology transfers, Person-In-Plant (PIP) support, root cause investigations, impact assessments, process improvements, and process monitoring. 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 interactions, Internal and External Manufacturing Operations, MSAT, Process Development, Quality Assurance, Quality Control, and Supply Chain. The role will support the Turnstone Manufacturing team, based in both Ottawa, CAN and San Diego, California, and external manufacturing partners. As such, flexibility to provide remote support 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):

  • Supporting investigations from process deviations and impact assessments, identifying appropriate subsequent CAPAs for clinical MFG productions
  • Communicate 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
  • Write and review technical documentation (batch records, SOPs, protocols & reports)
  • Author impact assessments in support of deviations and change controls
  • Support process related deviations and provide technical support to manufacturing
  • Suport process improvement activities involving cross-functional teams including Manufacturing, Quality, and Process Development
  • Perform risk assessments and investigations including root cause analysis utilizing a systematic approach and industry best practices
  • Determine corrective and preventative actions for process-related deviations
  • Support technology transfers and execution of verification runs
  • Support process FMEA
  • Participate and report to a cross-functional development team to advance production activities
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
  • ·       Provide on-site/remote Subject Matter Expert (SME) support for GMP operations at CMOs as Person-In-Plant (PIP)
  • Leading investigations from process deviations and impact assessments, identifying appropriate subsequent CAPAs for clinical MFG productions
  • Establish and manage business processes to drive process improvements using data-driven results (e.g., process monitoring, process development data, CAPAs)
  • Communicate 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
  • Write and review technical documentation (batch records, SOPs, protocols & reports)
  • Author impact assessments in support of deviations and change controls
  • Lead process related deviations and provide technical support to manufacturing
  • Lead process improvement initiatives involving cross-functional teams including Manufacturing, Quality, and Process Development
  • Perform risk assessments and investigations including root cause analysis utilizing a systematic approach and industry best practices
  • Determine corrective and preventative actions for process-related deviations
  • Support technology transfers and execution of verification runs
  • Support regulatory filings and facilityps as needed
  • Support process FMEA
  • Participate and report to a cross-functional development team to advance production activities
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues

 

Experience & Qualifications/Requirements:


  • Bachelor’s degree, in life sciences, engineering or related field and 4+ years of industry experience; Masters degree with 3+ years of experience; PhD and 1+ years of experience


  • 3+ years experience with the manufacturing and operational complexity of cell therapy-based therapeutics such as TIL, CAR-T, TCR, or stem cell products is required.
  • Enjoy working in a fast-paced environment, able to manage competing priorities effectively and adapt to changing priorities
  • Prior experience with GMP manufacturing to enable support of person-in-plant and manufacturing workflows
  • Experience managing external relationships such as CMO partners or clients as a CMO provider, with a mature and thoughtful communication approach to support strong partnerships

  • Knowledge of data management tools and statistical process controls, experience in statistical analysis using JMP or Minitab
  • Be able to travel to perform and complete listed responsibilities.
  • Experience in Process Development, Manufacturing, and/or Manufacturing Science and Technology (MSAT) for cell or gene therapies preferred
  •  Strong communication skills, both written and oral
  • Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant
  • This role will be formally positioned out of Memphis, TN or San Diego, CA although consideration will be made for remote candidates in North America

 


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.