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Analytical Leader

4 months ago

Canada Valid8 Financial, Inc. Full time

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.

Position Overview

We are seeking an innovative, highly motivated, Analytical Leader with method development and analytical life cycle management and tech transfer experience to work on innovative cancer treatment. This leader will work with Process Development, Research, Translational, and Quality departments to provide process and analytical development and CMC leadership to a team responsible for analytical characterization of cell therapy products, maturation of research analytical methodology into development and GMP, and analytical method transfer from/ to contract vendors. They will have excellent people leadership abilities and be responsible for overseeing lab studies, analyzing experimental data, and assuring careful documentation of resultant information.

Job Description

  • Lead Analytical activities in support of Turnstone products, including establishment of analytical control system strategy and identification of CQAs
  • Design, develop, implement, and document analytical method development and qualification in support of process development, product release and stability, and product characterization of cell therapies in Process Development
  • Identify, develop, and implement phase-appropriate analytical technologies and methods to study and characterize processes for production of cell therapies, including process improvements and efficiencies
  • Lead analytical laboratory staff in the selection, design and implementation of novel methods reflective of mechanism of action, including FACS/flow cytometry, with emphasis on automation and high throughput technologies to enable commercial readiness
  • Manage method and analytical technology transfers to/ from contract testing labs and the Turnstone facility as appropriate
  • Lead the analytical arm of investigations, deviations and CAPAs
  • Ensure standard operating procedures, test methods, sampling plans, batch records, and monitoring, trending and improvement process for all analytical methods meet the highest industry standard
  • Draft and review of CMC sections and supporting documents for Regulatory filings.
  • Participate in and defend regulatory audits and draft responses
  • Responsible for personnel recruitment, development, and retention
  • Ensure a collaborative work environment with key client groups in Research, Quality, Manufacturing and Process Development to support analytical method and process development as well as the characterization our products, e.g., lead maturation of research analytical methodology into Development and GMP, and method technology transfer to and from our partners

An attractive compensation package commensurate with this senior leadership role will be provided.

Qualifications

  • Ph.D. in Chemistry, Biochemistry, Biology, or related discipline with 10+ years of leadership experience in the biotech and/or pharmaceutical industry OR
  • MS Degree. in Chemistry, Biochemistry, Biology, or related discipline with 10+ years of leadership experience in the biotech and/or pharmaceutical industry OR
  • BS Degree. in Chemistry, Biochemistry, Biology, or related discipline with 12+ years of leadership experience in the biotech and/or pharmaceutical
  • Well versed in various analytical techniques such as flow cytometry, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.
  • Excellent understating of cellular processes and metabolism and experience with with T-cells
  • Knowledge of QbD approaches to analytical method development including DOE, risk assessment and statistical analysis
  • Deep knowledge of technical writing for Post-Approval Changes, BLA, IND
  • Demonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, cell therapy products, analytical method development, tech transfer, and method qualification/validation and process development
  • Demonstrated ability to work with both reporting organization and senior leadership teams
  • Excellent interpersonal - verbal and written communication skills
  • Ability to lead a diverse technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others
  • Expertise with analytical method development and qualification and analysis of cell therapy products
  • Proficient in MS Word, Excel, PowerPoint, and other applications
  • Comfortable in a dynamic, growing company
  • Agile mindset and ability to adjust workload based upon changing priorities
  • Creative and thoughtful problem-solving skills
  • Able to take a proactive, solution-oriented approach
  • Excellent interpersonal communication skills, including the ability to listen well and appropriately inform and guide stakeholders
  • Ability to work in, lead and foster cross-functional, collaborative teams
  • Ability to effectively present results and proposals to audiences of all levels
  • Experience supporting, developing, and mentoring staff and creating inclusive, high-performing teams
  • Someone who leads by example

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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