Leading the Fight
Against Solid Tumors

About Us

Pioneering Novel Approaches
to Deliver on the Promise of TILs


At Turnstone, our mission is to develop new medicines to treat and cure patients with solid tumors.

Solid tumors present a major burden to society, with high mortality and poor outcomes associated with more advanced disease. Approved immunotherapies represent a significant advancement in the treatment of solid tumors, but many patients either do not respond or experience relapsed disease following an initial response. We believe the most significant challenge to creating curative immunotherapies in these patients is the low numbers of T cells that can recognize and attack the tumor, which we refer to as tumor‑reactive T cells.

To address this problem, we are pioneering a differentiated approach to tumor infiltrating lymphocytes, or TILs. We are developing next-generation TIL therapies by selecting the most potent (meaning able to mediate an anti-tumor response) and tumor-reactive T cells, which we refer to as Selected TILs. We are developing next-generation TIL therapies for potential treatment across multiple solid tumors.

Leadership

Experienced Team of
Leaders and Innovators

Turnstone has assembled a seasoned management team, an accomplished Board of Directors and a distinguished Scientific Advisory Board whose contributions to science have meaningfully advanced the field and helped inform our understanding of the relationship between cancer and the immune system.

Our passionate team of leaders comprises world-renowned professionals with deep expertise in TILs, cell therapy, tumor immunology, innate and adaptive immunity, oncolytic viruses, and in the discovery and development, manufacturing, and business and commercial development of complex biologics.

sammy-bg

Sammy Farah, PhD, MBA

President & Chief Executive Officer
steward-bg

Stewart Abbot, PhD

Chief Scientific Officer
saryah-bg

Saryah Azmat

Chief Business Officer
mike-turnstone

Mike Burgess, MBChB, PhD

Interim Chief Medical Officer
Vijay Chiruvolu

Vijay Chiruvolu, PhD

Interim Chief Technology Officer
venkat-bg

Venkat Ramanan, PhD

Chief Financial Officer
stojd

David Stojdl, PhD

SVP, Discovery Research
chad

Chad Green, PhD

SVP, Technical Operations
langer

TJ Langer

SVP, Cell Therapy Development and External Innovation
adina

Adina Pelusio

SVP, Clinical Operations
Karen Major new

Karen Major

VP, Regulatory
george

George Smith, MBA, PhD

VP, Cell Therapy Business Operations
jerel-1

Jerel Davis, PhD

Chairman & Director
Versant Ventures
mike

Mike Burgess, MBChB, PhD

Executive Director
Turnstone Biologics
sammy

Sammy Farah, PhD, MBA

Director
Turnstone Biologics
robert

Robert Gould

Director
Fulcrum Therapeutics
rishi-1

Rishi Gupta, JD

Director
OrbiMed
pat

Patrick Machado

Director
Former CFO/CBO Medivation
Kanya_R

Kanya Rajangam, MD, PhD

Director
Senti Biosciences
jeff

Jeff Courtney

In Memoriam

Our Approach

Next-Generation Approaches
with Selected TIL Therapy

Turnstone is pioneering a differentiated approach to tumor infiltrating lymphocytes, or TILs. We are developing next-generation TIL therapies by selecting the most potent (meaning able to mediate an anti-tumor response) and tumor-reactive T cells, which we refer to as Selected TILs. Unlike other approaches that rely on standard “bulk TILs” that have demonstrated objective responses in clinical trials only in limited tumor types, we are developing our Selected TILs for potential treatment across the majority of solid tumors.

Tumor infiltrating lymphocytes (TILs) are a type of cell therapy that harness the patient’s own immune cells to target their own tumors. TIL therapy involves the isolation of lymphocytes from the patient’s tumor, expansion of the isolated cells outside the body, and then infusion of the cells back into the patient. TILs have the ability to penetrate, recognize, and kill cancer cells and offer potential to treat or cure solid tumors.

Turnstone’s next-generation Selected TILs have the potential for treatment of multiple solid tumors. Our innovative Selected TIL approach focuses on selecting and expanding the most potent tumor-reactive T cells to overcome the limitations of bulk TILs. This approach is grounded in work conducted in academia that demonstrated improved clinical responses for Selected TILs in solid tumors. We are leveraging this work to establish a standardized manufacturing process for large scale production of our Selected TILs.

Our Selected TIL approach employs the following foundational principles with the goal of yielding the greatest number and proportion of tumor-reactive T cells in our TIL products:

  • Unbiased identification of patient-specific tumor antigens.

    We seek to identify the most comprehensive set of patient-specific tumor antigens. We use an unbiased identification process that aims to find and capture the greatest diversity of antigens with the potential to drive the most robust T cell response. Our proprietary approach is unlike other TIL products that are biased toward a specific subset or class of antigen(s), which may miss relevant tumor antigens or focus on the wrong targets.

  • Selection of greatest breadth of tumor-reactive T cells from patient extracted TILs.

    Our goal is to capture and isolate the greatest number and proportion of a patient’s tumor-reactive T cells that have the potential to attack and destroy heterogeneous solid tumors.  We aim to select the greatest diversity of T cells by using a function-based screening process that confirms reactivity to the identified patient-specific tumor antigens rather than relying on a bioinformatics-based prediction algorithm that may not be truly predictive.

  • Expansion of tumor-reactive T cells and removal of non-tumor-reactive bystander cells.

    We expand our selected tumor-reactive TIL population to magnitudes consistent with bulk TIL products and actively remove unnecessary bystander cells. This selective expansion resulted in a substantially higher proportion of tumor-reactive T cells in the final product, which we believe will result in targeted tumor killing.

Selected TIL Therapy diagram

Our Superior Killing Virus, or SKV Vaccinia, is derived from the Copenhagen strain of vaccinia that exhibits powerful oncolytic activity in human tumors and we have engineered the viral backbone to develop a highly potent viral immunotherapy. The SKV Vaccinia backbone modifications were specifically designed and selected to support:

  • Enhanced immune activation through removal of immunosuppressive genes
  • Highly selective tumor targeting for increased potency and safety
  • Delivery of multiple transgenes to encode for specific functions
  • Optimized viral spread and infection in the tumor
  • Systemic and intra-tumoral (IT) administration

RIVAL-01, our lead clinical stage viral immunotherapy program, being developed in partnership with Takeda, utilizes the inherent activity of the SKV Vaccinia backbone and includes a rationally selected payload combination designed to further drive oncolytic and immune-mediated killing of the tumor. The three key payloads encoded in RIVAL-01 include:

  • Flt3L, a growth factor to support the differentiation and expansion of highly relevant antigen-presenting dendritic cells which are critical for anti-tumor immune response
  • IL-12, a pro-inflammatory cytokine to promote T-cell cytotoxicity, activate innate immune cells and minimize immunosuppression
  • Anti-CTLA-4, an antibody that inhibits CTLA-4-mediated immunosuppression and downregulation of T-cell activation

We believe that Turnstone is strongly positioned to be a leader in leveraging viral immunotherapy to further increase the activity of our TIL therapies, if approved.

Viral immunotherapy is a therapeutic modality with widespread potential to drive and modulate immune responses to solid tumors. Many viruses have inherent oncolytic activity that can be modulated through genetic engineering. These viruses preferentially infect, replicate within, and kill malignant tumor cells, and can induce broad immune responses. Viral immunotherapies are designed to convert immunologically unresponsive “cold” tumor microenvironments to more reactive “hot” tumor microenvironments and thereby enhance the activity of other immunotherapies.

We are initially evaluating viral immunotherapies in combination with our lead Selected TIL product candidate, TIDAL-01, via two approaches:

  • Administration of virus prior to TIL extraction to optimize TIL harvest and broaden applicability to additional tumor types with low immune cell infiltration, and
  • Administration of virus following treatment with TIDAL-01 to optimize TIL trafficking and infiltration into solid tumors and to support the anti-tumor functions of infiltrating immune cells.
TIL virus diagram - July 2023

Scientific Resources

Explore academic selection strategies that have demonstrated clinical proof of concept, relevant to Turnstone’s differentiated approach to TIL therapy:


Learn more about our scientific and clinical research, and the potential of Turnstone’s Selected TIL therapy in a broad range of solid tumors:

Pipeline

Designed to Shift the Paradigm
for the Treatment of Solid Tumors

We are applying our Selected TIL approach for the potential treatment of a wide range of solid tumors. We are developing a broad pipeline aimed at improving outcomes for patients with cancers, as illustrated in the chart below.

Program Product Overview Key Indications Preclinical Phase 1 Phase 2 Phase 3 Next Anticipated Milestone
Selected TILs
TIDAL-01 Tumor-reactive
Selected TILs
Breast Cancer,
Colorectal cancer,
Uveal Melanoma
+
Initial clinical data in mid-2024
Cutaneous and non-cutaneous melanomas
+
Moffitt Collaboration*
Combination with
viral immunotherapy
Solid tumors
IND submission
TIDAL-02 Selected TILs with next-
gen manufacturing and
TIL quality enhancements
Solid tumors
IND submission
Selected TILs
PreclinicalPhase 1Phase 2Phase 3

TIDAL-01

Tumor-reactive Selected TILs
Breast Cancer, Colorectal cancer, Uveal Melanoma

+

TIDAL-01

Tumor-reactive selected TILs
Cutaneous and non-cutaneous melanomas

Moffitt Logo
+

TIDAL-01

Combination with viral immunotherapy
Solid tumors

TIDAL-02

Selected TILs with next-gen manufacturing and TIL quality enhancements
Solid tumors

*Investigator sponsored trial at Moffitt Cancer Center

Partners

Optimizing Technological Innovations
Through Strategic Partnerships

We are backed by successful top-tier life science and biotech investors committed to Turnstone’s growth, and have forged select collaborations with key academic institutions, major biopharmaceutical companies, elite researchers and prominent international cancer medical centers to support the development of our next-generation Selected TIL and immunotherapy pipeline.

Together with our strategic partners, we are devoted to delivering transformative therapies to the millions of cancer patients underserved by current treatment options.

Key Collaborators

National Cancer Institute (NCI)

In November 2022, Turnstone announced a Cooperative Research and Development Agreement with the National Cancer Institute (NCI) to study TIL therapy in novel combinations with viral immunotherapy.

Moffitt Logo

In July 2022, Turnstone announced a strategic alliance with Moffitt Cancer Center focused on the development of Turnstone’s pipeline of tumor-reactive selected TILs targeting solid tumors.

CRCHUM Logo

In April 2022, Turnstone announced a TIL therapy research collaboration with CRCHUM to develop novel strategies for tumor-reactive T-cell selection in Turnstone’s TIL therapy candidates against solid tumor indications.

News

Careers

Empowering Our People
to Drive Science Forward

Turnstone is committed to true innovation, fearless execution and operational excellence. Our team work 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.

We continue to build a values-driven organization that embraces diversity, equity, and recognizes that the sum of our parts drives more success than any single individual. Our talented people and deeply ingrained culture are vital elements in maintaining our competitive edge in the vast biotech universe and key to unlocking the full potential of cancer immunotherapy.

If you are passionate about making a difference for patients and are excited by our mission and science, Turnstone might just be for you.

Team Opportunities

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.

Job Description:

We are seeking an innovative, highly motivated, versatile leader to join us as our Clinical Regulatory Leader. This role will report to the Vice President, Clinical Development and sit will be the regulatory representative at various core teams. The successful candidate will be results-driven and a highly skilled Clinical Regulatory Leader with extensive experience in guiding regulatory strategies and ensuring compliance for pharmaceutical and biotechnology companies. The ideal candidate will be adept at navigating the complex landscape of regulatory affairs, and have a proven track record of successfully leading cross-functional teams to achieve regulatory milestones and approvals.

This is both a strategic and execution focused role requiring someone to see the big picture, plan, and roll up their sleeves and get things done. This role requires proven leadership to effectively communicate, coordinate, and collaborate cross-functionally with Clinical Operations, External Manufacturing, Quality, Technical Operations, Research, Finance, IT and Commercial teams.

Responsibilities:

    • Provide expert, technical and professional advice, guidance and leadership to the Company on Regulatory Affairs matters.
    • Proactively participate in design of global regulatory strategies for the development of cell therapy products
    • Serve as one of the primary liaison between Turnstone and all strategic partners/ partner companies in regulatory topics/issues.
    • Plan, oversee and manage preparation and submissions (including but not limited to pre-IND, Initial IND/CTA and amendments, Safety reporting, BLA, Orphan drug designation); this will require strong regulatory knowledge and understanding of the underlying science, cross-functional interactions, and excellent project management and writing skills
    • Participate in interactions with regulatory agencies to solidify strategy and address regulatory comments
    • Lead preparation of agency meetings and actively participate in scheduled meetings
    • Drive adherence to regulatory requirements and guidelines
    • Perform regulatory intelligence activities – monitor regulation changes and competitor trends/strategy
    • Provide regulatory input regarding budget
    • With Clinical Operations and Quality Assurance, ensure compliance of Clinical Development with GCPs and SOPs and other relevant regulations.
    • Review and approve departmental and Clinical SOPs and revisions.
    • Manage all relevant contract relationships.
    • Maintain a thorough understanding of GCPs, internal SOPs, and guidance documents issued by various regulatory agencies, including the US-FDA, EMA, and ICH.
    • Maintain a regulatory document system.

 

Education and Experience:

    • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
    • Regulatory Affairs Certification (RAC) preferred
    • Background ideally oncology cell therapy or biologics
    • 8 + year experience with PhD; 10+ years with Masters or bachelor’s degrees
    • Proven track record of managing critical projects as a part of an interdisciplinary team
    • Proven track record of representing the department in project teams, committees and external meetings
    • Prior experience managing regulatory submissions to deadlines
    • Thorough understanding of relevant drug development regulations and guidelines
    • Outstanding interpersonal and communication (written and verbal) skills
    • Effective task planning and coordination abilities
    • Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)

    COMPENSATION

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

  • To Apply:
    Please click here to apply!

 

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.

 

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.

Job Description:

We are seeking an innovative, highly motivated, versatile leader to join us as our Clinical Regulatory Leader. This role will report to the Vice President, Clinical Development and sit will be the regulatory representative at various core teams. The successful candidate will be results-driven and a highly skilled Clinical Regulatory Leader with extensive experience in guiding regulatory strategies and ensuring compliance for pharmaceutical and biotechnology companies. The ideal candidate will be adept at navigating the complex landscape of regulatory affairs, and have a proven track record of successfully leading cross-functional teams to achieve regulatory milestones and approvals.

This is both a strategic and execution focused role requiring someone to see the big picture, plan, and roll up their sleeves and get things done. This role requires proven leadership to effectively communicate, coordinate, and collaborate cross-functionally with Clinical Operations, External Manufacturing, Quality, Technical Operations, Research, Finance, IT and Commercial teams.

Responsibilities:

    • Provide expert, technical and professional advice, guidance and leadership to the Company on Regulatory Affairs matters.
    • Proactively participate in design of global regulatory strategies for the development of cell therapy products
    • Serve as one of the primary liaison between Turnstone and all strategic partners/ partner companies in regulatory topics/issues.
    • Plan, oversee and manage preparation and submissions (including but not limited to pre-IND, Initial IND/CTA and amendments, Safety reporting, BLA, Orphan drug designation); this will require strong regulatory knowledge and understanding of the underlying science, cross-functional interactions, and excellent project management and writing skills
    • Participate in interactions with regulatory agencies to solidify strategy and address regulatory comments
    • Lead preparation of agency meetings and actively participate in scheduled meetings
    • Drive adherence to regulatory requirements and guidelines
    • Perform regulatory intelligence activities – monitor regulation changes and competitor trends/strategy
    • Provide regulatory input regarding budget
    • With Clinical Operations and Quality Assurance, ensure compliance of Clinical Development with GCPs and SOPs and other relevant regulations.
    • Review and approve departmental and Clinical SOPs and revisions.
    • Manage all relevant contract relationships.
    • Maintain a thorough understanding of GCPs, internal SOPs, and guidance documents issued by various regulatory agencies, including the US-FDA, EMA, and ICH.
    • Maintain a regulatory document system.

 

Education and Experience:

    • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
    • Regulatory Affairs Certification (RAC) preferred
    • Background ideally oncology cell therapy or biologics
    • 8 + year experience with PhD; 10+ years with Masters or bachelor’s degrees
    • Proven track record of managing critical projects as a part of an interdisciplinary team
    • Proven track record of representing the department in project teams, committees and external meetings
    • Prior experience managing regulatory submissions to deadlines
    • Thorough understanding of relevant drug development regulations and guidelines
    • Outstanding interpersonal and communication (written and verbal) skills
    • Effective task planning and coordination abilities
    • Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)

    COMPENSATION

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

  • To Apply:
    Please click here to apply!

 

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.

 

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.

Job Description:

Turnstone Biologics is seeking a driven and experienced Process Engineer 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.

Responsibilities:

• Interact with Manufacturing leadership to influence strategic and technical guidance on ongoing clinical production
• Provide on-site/remote Subject Matter Expert (SME) support for GMP operations at CMOs as Person-In-Plant (PIP)
• 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
• Support 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

Education and Experience:

    • • 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
      • 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

The anticipated salary range for this role is $120,000 – $145,000.

To Apply:

Please click here to apply!

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.

 

 

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:

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.

 

The Responsibilities include but are not limited to the following:

  • 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
  • Responsible for budget forecasting including resource modeling
  • 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
  •  

    Experience:

    • 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

    To Apply:

    Please click here to apply!

    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.

     

    Contact

    General Inquiries

    info@turnstonebio.com

     

    Partner
    with Us

    bd@turnstonebio.com

     

    Talent Acquisition

    hr@turnstonebio.com

     

    Investors & Media

    ir@turnstonebio.com

     

    Clinical Trial Inquiries

    ct@turnstonebio.com