Driving The Power of Innate and Adaptive Tumor Immunity

Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

The Research Associate or Senior Associate, in this individual contributor, lab-based role, will work in a collaborative environment to perform Analytical testing and development to support Turnstone’s TIL cell therapy development programs. This position will join the development group and work with the analytical testing group that values data quality, high productivity and teamwork. The key deliverables for this role are precise, accurate, and high-quality data presented, communicated, and integrated in an effective manner. This position will require thorough documentation of all experimental steps and final data readout.

Responsibilities:

• Execution of key analytical methods such as multi-parameter flow cytometry, bioassays and qPCR-based methods and data analysis in support of process development activities, product characterization, and raw materials testing.
• Provide support to other groups for assay development, qualification, and transfer into Analytical Development
• Developing processes and methods to improve lab execution and data analysis
• Timely and thorough documentation and completion of electronic laboratory notebooks
• Author reports detailing experimental work and summarizing results
• Contribute to an overall high-performing laboratory, with a willingness to contribute in all ways, such as ordering, tracking, and maintaining inventory of lab supplies and reagents

Experience & Qualifications:

• BS in a scientific discipline 2+ yrs experience (1+yrs with MS) of relevant industrial experience. Final role can be commensurate with relevant industry experience.
• Experience with flow cytometry or cell-based bioassays, ELISA, and PCR techniques
• Experience with aseptic cell culture and cell-based assays.
• Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench.
• Experience with other techniques in molecular biology, such as RT-PCR is preferred
• Previous experience with cell therapy products is preferred
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment
• Working knowledge of statistical software (R, JMP, Minitab) is preferred.

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

As an Engineer or Sr. Engineer (depending on your relevant experiences and expertise), you will provide process development and engineering support for process design, characterization, and improvements with a goal of ultimately enabling GMP manufacturing. Primary responsibility will be to design, lead, and execute experiments that contribute to development and characterization of the TIL cell therapy manufacturing process. Experiments will be performed to identify and define Critical Process Parameters and process ranges. Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiments (DoEs), and provide technical support for manufacturing sciences, technology, and process changes. Turnstone works in a highly cross-functional environment, so your contributions will be critical for our pre-clinical, clinical, and regulatory workflows, with an opportunity to engage and enable your colleagues across the business.

Responsibilities:

• Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
• Lead and execute laboratory studies to support process design and development, characterization and process improvements
• Write and review technical documentation
• Participate and report to a cross-functional development team to advance production activities
• Assist in technology transfer to GMP manufacturing by generating development reports and providing on-site technical support.
• Authoring and assistance in the technical review of supporting documents, reports, including CMC sections for regulatory filings.
• This is a hands-on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.
• Act as technical expert to train and supervise process technicians

Experience & Qualifications:

• Minimum of 3 years of relevant industry experience, with role flexibility available commensurate with experience
• Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required
• Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Cell culture and aseptic processing experience
• Working knowledge of scientific and engineering principles
• Experience in statistical analysis using JMP or Minitab
• Practical experience in GMP operations
• Ability to function efficiently and independently in a changing environment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• The primary location of the position is San Diego, but may be required to travel, based on business priorities

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Our Virus Manufacturing (VMFG) team is growing. As part of the Technical Operations organization, the VMFG team is responsible for the GMP manufacture of Cell Banks, Virus Banks, Drug Substance and Drug Product for our clinical-stage assets. VMFG supports technology transfers and collaborates closely with the Virus Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As an Associate Engineer of Virus Manufacturing on the VMFG team, you will be tasked with supporting manufacturing campaigns from end-to-end within our external contract manufacturing organization (CMO) network.

The responsibilities for this position span across our multi-modal platform and include:

– Support virus manufacturing campaigns with external CMO partners
– Support virus manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation
– Support ongoing batch monitoring including person-in-plant coverage
– Support cross functional teams troubleshooting and resolving issues with ongoing manufacturing runs
– Support virus manufacturing campaign closeout including the review of executed batch records and shipping/logistics of finished material
– Support process development, engineering runs, and other process scale-up related studies
– Support the identification and selection of new external CMO partners
– Support drafting of regulatory documentation including INDs, CTAs, etc.
– Represent the Virus MFG team at Technical Operations cross-functional program meetings

Experience & Qualifications:

• This Associate Engineer role will be formally positioned out of our Ottawa, Canada office
• Willingness to travel (when it’s safe as it pertains to global pandemic) up to 10-30% to other Turnstone sites and/or external CMOs throughout North America (USA, Canada) and Europe
• BSc in a science, engineering, or biotechnology related discipline; MSc considered an asset
• 1-3 years’ experience in a technical operations or research/development role
• Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics
• Experience with good manufacturing practices (GMP) in a clinical or commercial manufacturing setting
• Experience with the qualification and operational use of single use, small scale mammalian cell culture, tangential flow filtration, and/or chromatography-based purification equipment and raw materials
• Comfortable in a dynamic environment with competing priorities
• Strong technical writing skills
• Teamwork – willingness to lead and willingness to be lead when it’s appropriate
• Positive Attitude – interest in learning how to adapt to fast-growing teams and a dynamic virtual working environment
• Communication – interest in learning how to communicate effectively cross functionally with multiple levels in the organization and externally to global partners
• Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better
• Excellent computer skills, including Microsoft Excel and PowerPoint

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

The Manager (or Sr Manager), Supply Planning will be responsible for investigational product (IP) supply for a clinical development program which is rapidly maturing and expanding to multiple global jurisdictions. The intent of the role is to start with a focus on our active early phase viral immunotherapy clinical studies, with potential opportunities to support other product modalities and product intermediates.

The responsibilities for this position include but are not limited to:

– Lead the integration of the clinical development plan and the manufacturing plan to create an actionable, end-to-end, long range strategic supply plan

– Lead the constant iterative re-modeling of supply plan scenarios to help inform program-level and functional-level decision-making across clinical development and technical operations

– Lead manufacturing campaigns at label-and-pack contract manufacturing organization (CMO) partners to create finished goods (FG/IP) ready for clinical distribution

– Partner with Regulatory Affairs and Clinical Operations to develop and manage IP and ancillary product labels for multiple jurisdictions

– Lead selection, strategic integration, and activation, and ongoing operation of clinical supply depots for IP, ancillary supplies, and other stored materials required for global clinical trials

– Monitor clinical IP supplies at sites and depots and provide supply metrics to support clinical operations needs around the globe

– Lead relationship management of label-and-pack CMO partners and the evaluation and selection of new CMO partners

– Lead GMP inventory management, including the tracking of actual inventory, as well as driving development of the tools, systems, and naming conventions utilized to enable efficiency and compliance

– Serve as a key stakeholder in the Technical Operations and Clinical Operations interface, including leading cross-functional meetings and teams to achieve integration of workstreams (production planning, testing planning, clinical operations, etc.)

Experience & Qualifications:

This Manager (or Sr Manager) role will be formally positioned out of our San Diego, CA office but working from home/remotely will be a part of the normal work routine

– Willingness to travel (during normal times) up to 10-20% to other Turnstones sites and/or external CMOs throughout North America (USA, Canada) and Europe

– BS degree in a relevant life sciences, engineering, or business management discipline

– 5-8 years’ experience in a clinical supply chain management across early to late phases of clinical development and multiple jurisdiction (Europe, Asia-Pacific, North America)

– 3-5 years’ experience in a team and/or cross-functional leadership role

– Strong understanding of and experience with GMP and GCP requirements

– Experience with implementation and operations of ERP (Oracle, SAP or NetSuite) and Interactive Response Technology (IRT) systems

– Experience working with and managing multiple third-party/external partners

– Experience with global clinical trials, ultralow cold chain, and sourcing of comparator IMPs highly preferred

– Excellent Excel abilities required

– Teamwork – willingness to lead and willingness to be lead when it’s appropriate

– Positive Attitude – ability to adapt to fast-growing teams and a dynamic virtual working environment

– Communication – must be able to communicate effectively cross functionally with multiple levels in the organization and externally to global partners

– Growth mindset – constant approach of challenging oneself to learn more, learn faster, and learn better

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

The Analytical Life Cycle Management team is growing quickly and establishing workflows and practices to ensure analytical excellence of the QC test methods that are used for all stages of product manufacturing and GMP release and characterization of Turnstone’s novel biotherapeutics. Reporting into the Technical Operations department, this team is responsible for life-cycle management of current and future analytical methods and alignment with applicable policies and regulatory requirements. To support this goal, the team is responsible and accountable for continuous test method improvement activities, for enabling innovation, and for introduction of new technologies. The team works closely with Quality Control and contract testing organizations, overseeing qualification, and examining method performance and trending to support ongoing method optimization and improvements. As the Scientist of the ALCM team, you will report to the Associate Director of ALCM.

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative leader. Passionate about being a part of a critical function of a growing company and continuous learning? You will be engaged in a team and a workflow that plays a critical role in getting cutting edge therapies to people suffering from cancer.

We are in the early stages of building strategies, structures, and processes so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Position Responsibilities:

· This role will be formally positioned out of Ottawa, Canada or San Diego, California

· Extensive experience developing and troubleshooting cell-based and potency assays and ensuring that life-cycle management of analytical methods is implemented and aligned with applicable policy and regulatory requirements

· Solid experience with other analytical techniques such as Flow Cytometry, Next Generation Sequencing, etc.

· Knowledge and experience in analytical method development, method validation, and method transfers.

· Working knowledge and application of GMPs/GLPs principles, ICH guidelines and compendial methods

· Experience in Cell therapy, vaccines, or biological products

· Comfortable in a dynamic environment with competing priorities

· Strong technical writing skills

· Strong communication both written and spoken

· Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant

· Excellent computer skills, including Microsoft Excel and PowerPoint

· 5+ years of related experience in area of Pharmaceutical/Biologics industry

· M.Sc./Ph.D in Biological sciences or Life Sciences fields or B.Sc. with extensive industry experience.

Requirements:

· Develop Analytical Target Profiles for new and existing test methods

· Perform Lifecycle Management of Analytical Procedures: perform assessments of method validation/qualification and performance; identify gaps and required corrective actions; trend, analyze and interpret data.

· Perform analytical method development, method qualification/validation and method transfers

· Prepare and/or coordinate with contract testing organizations for analytical methods, protocols, reports and other documents related to analytical development and qualification/validation activities

· Keep up to date with scientific and technical developments

· Responsible for complex decision making, optimization and troubleshooting of methodologies

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

The Quality Control team is growing quickly and establishing our work flows and practices to ensure analytical and operational excellence in support of Turnstone’s novel cancer immunotherapies and cell therapy products. Reporting into the Technical Operations department, this team is responsible for the GMP testing, QC release, Shelf life Stability and QC vendor management program of our RIVAL and TIDAL products. To support this goal, the team oversees all GMP testing activities at our global network of contract testing organizations in addition to specification setting and management of inventory, cell banks, and critical reagents in accordance to regulatory and compendial requirements. The team works closely with Manufacturing, ALCM, and Contract organizations supporting product comparability, qualification, and tech transfers to GMP partners. As the Senior Scientist of the QC team, you will report to the Associate Director of QC and will have the opportunity to work with all clinical-stage assets (viral and cell therapy).

The responsibilities for this role include:

· Lead a small team of high-performing scientists, supporting them in their goals so that they can be the best versions of themselves every day, while being engaged and fulfilled. The team is small and flexible and will require a leader that is able and willing to roll up their sleeves and help in the day to day as much as build thoughtful systems supporting the team’s growth and operations.

· Manage the QC Lot release program for multiple products in early phase clinical development to meet corporate goals and clinic needs

· Perform analytical data review and provide technical expertise to support data review of viral and cell therapy-based methods for lot release, characterization, and stability testing

· Optimize and maintain a sustainable stability program management system for diverse products

· Design and develop stability testing/trending strategies to support shelf-life stability claims

· Implement systems to routinely analyze release and stability data and trends to support setting specifications, shelf life stability, organizational needs, and continuous improvement activities

· Develops and generate metrics and KPIs to capture RFT (Right First Time) supporting operational excellence initiatives

Experience

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative leader. Passionate about being a part of a critical function of a growing company and continuous learning? You will be engaged in building a team and a workflow that plays a critical role in getting cutting edge therapies to people suffering from cancer.

We are in the early stages of building strategies, structures, and processes so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

· This role will be formally positioned out of Ottawa, Canada

· Strong knowledge of a complement of FDA, EMA, ICH, USP, and EP guidelines and regulations for QC and stability program implementation of biological or cell therapy products

· Experience with implementation, optimization, and management of shelf-life stability programs for novel therapeutics

· Extensive knowledge of QC analytical testing supporting biologics, vaccines, or cell therapy products e.g. cell based assays, compendial methods, flow cytometry, cell counting, ELISA, PCR. Special consideration will be given to candidates with a working knowledge of next-generation sequencing technologies

· Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

· Ability to make informed, data-driven and risk-based timely decisions

· Strong aptitude to enable trust, build authentic relationships, constructively challenge conventional thinking, influence stakeholders, lead and cooperate in a team setting, share information, and deliver results

· Experience with QC analysis and investigations applicable to for e.g. products, raw materials, EM Programs, chemistry, microbiology, and molecular biology assays

· Strong communication both written and spoken

· Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant

· Excellent computer skills, including Microsoft Excel and statistical software such as JMP

· 8+ years of related experience in area of Pharmaceutical/Biologics industry

· M.Sc./Ph.D in Biological sciences or Life Sciences fields or B.Sc. with extensive industry experience.

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

As the Sr. Engineer/Sr. Scientist of upstream process development, you will report to the Head of Drug Substance Process Development. As part of this role, you will lead all of the technical aspects of our virus process development program across cell line, media/feed strategies, infection/harvest and bioreactor scale up and development. You will be a critical member of our Process Development team and help contribute to the overall strategy and execution of our virus CMC and translation. Specifically, you will:

• Develop the upstream process development targets and strategy to reach our program needs across a suite of virus-based drug products
• Contrinute as the subject matter expert to the overall upstream process development of our virus pipeline supporting cell line development, media development, feed strategy development, infection and harvest conditions, and bioreactor scale up
• Lead interactions with our external CDMO network to accomplish efficient process development advancement
• Collaborate with Drug Product development, Manfuacturing Sciences and Manufacturing Operations to support smooth translation of processes through inception to clinical manufacturing
• Participate in technology transfer of our processes to local and international GMP partners
• Support Manufacturing Sciences team with scale-up of the manufacturing processes, and deviation investigations
• Employ QbD principals to perform process characterization studies
• Act as subject matter expert for review of data in regulatory filings

What’s in it for you?:

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size (approximately 100 team members, and growing fast!) we will give you plenty of opportunities to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportinites for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Experience and Qualifications:

Turnstone Technical Operations is a virtual organization, where the majority of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:

• Scientist or Engineer with advanced degree in Biochemical Engineering, Biotechnology or in other related Science field (virology, biology, biochemistry, protein chemistry, pharmaceutical chemistry)
• 5-7 years of experience in upstream process development within biotech/pharma
• Experience with process scale up, deployment and technology transfer of complex biological processes in a GMP manufacturing environment, and process qualification/validation are strongly preferred
• Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses) is required
• Experience with media and feed development strategies
• Expertise in microcarrier, and aseptic process experience, is strongly preferred
• Experience leading bioreactor development workstreams and support scale up from benchm, to pilot, to GMP scale SUB
• Excellent communication skills with the proven ability to build open and collaborative relationships, work effectively as a member of a multidisciplinary team
• Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment
• The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
• Able to manage competing priorities effectively and adapt to changing priorities
• Analytical and quantitative approach to problem solving, with the ability to self-start and independently investigate technically challenging problems
• Excellent computer skills, including JMP, Microsoft Excel, Powerpoint and Word

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

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 are what we call ‘another Thursday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.

Responsibilities include: working as part of a team at Turnstone’s Ottawa lab, running established complex analytics to support product characterization, preclinical study sample testing, and analytical development.

Experience and qualifications:

This role is best suited for an analyst early in their career, looking for a development opportunity, and with the following experience:

· 2+ years of hands-on experience in the lab (school lab experience counts) performing several methods such as:
o virological and cellular assays (tissue culture, plaque assay, killing assay, TCID50, infections, etc)
o molecular assays (qPCR, PCR, Bradford, ELISAs, Western blot, etc)
· Education: diploma or degree in biochemistry, biotechnology, or relevant field
· Agile in a lab setting, able to quickly learn established methods
· Experience following a procedure several times to generate precise and accurate results
· Careful and diligent method execution and reporting
· Organized and able to manage time to enable the execution of several experiments at once when required
· Very comfortable using Microsoft applications (Excel, Word, PowerPoint). Experience with analytical software such as JMP would be an asset.

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

As the Associate Scientist in the Analytical Development team, you will report to the Sr. Scientist of Analytical Development within the Virus Development and Manufacturing department. You will be a critical member of the Virus Development and Manufacturing team striving to address the biophysical analytical needs and support product characterization, in-process characterization, process development and investigations for a portfolio of live virus therapeutics based in our RIVAL platform (highly engineered vaccinia virus).

The responsibilities for this role include:
• Drive the development of biophysical and analytical chemical methods including but not limited to DLS, NTA, LC-MS, HPLC, SEM, SEC-MALS and flow cytometry
• Support the development and continuous improvement of molecular assays including qPCRs and ELISAs
• Support product characterization, in-process characterization, process-related investigations and transfer of analytical methods
• Work closely and effectively with external CROs and vendors to drive projects to completion in a timely and scientifically sound manner
• Collaborate with the Process Development and Formulation and Drug Product Development teams to identify analytical needs and make decisions on the technologies that support these needs
• Collaborate with the Analytical Operations, Analytical Life Cycle Management and QC teams for the development and transfer of new methods for characterization and/or release
• Perform data analysis and trend critical metrics to monitor method performance across various testing sites

What’s in it for you?

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth, we will give you plenty of opportunities for you to be an inspirational and collaborative leader. Passionate about being a part of a critical function of a growing company and continuous learning? You will be engaged in building a team and a workflow that plays a critical role in getting cutting edge therapies to people suffering from cancer.

We are in the early stages of building strategies, structures, and processes so this role will be busy and expanding. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Experience:

Turnstone Technical Operations is a virtual organization, where the majority of our wet bench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:

• B.Sc./M.Sc. in Biophysical/Analytical Chemistry or Life Sciences fields
• 2+ years of experience with developing and optimizing biophysical and chemical analytical techniques in Pharmaceutical/Biologics industry
• Experience with molecular-based assays is preferred
• Experience with live virus products or biological products is an asset
• Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment
• Able to manage competing priorities effectively and adapt to changing priorities
• Excellent communication skills with the proven ability to build open and collaborative relationships, working effectively as a member of a multidisciplinary team
• Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
• Excellent computer skills, including Microsoft Excel and statistical software, such as JMP

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

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 are what we call ‘another Wednesday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.

As the Head of Drug Substance Process Development, you will provide leadership to a team of Scientists and Engineers and drive the development strategy for early clinical development through commercialization for all upstream and downstream process development across our suite of viral-based drug products. Reporting to the head of viral development, you will:

· Participate as an active member of the Viral Development leadership team, to support overall analytical and process development needs across Drug Substance and Drug Product development

· Participate in a cross-functional matrix team (Clinical, Manufacturing, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall Drug Substance development strategy for a suite of viral-based products (RIVAL pipeline)

· Provide leadership and guidance to a team of Scientists and Engineers

· Provide a depth of technical leadership for process development spanning cell line and media development, cell strain optimization, bioreactor design, selection and control strategies, harvest, lysis, clarification, chromatography and separation/filtration technologies

· Represent Turnstone CMC externally at our expansive international CDMO network

· Work closely with the Analytical Development team to ensure appropriate and robust assays are in place to support process characterization studies

· Participation in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdictions as they emerge

· Drive corporate and departmental objectives to completion through strong collaboration with a broad range of internal functions, in particular Regulatory Affairs and Quality Assurance

Experience & Qualifications:

In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size (approximately 100 team members, and growing fast!) we will give you plenty of opportunities to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!

We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

The Details

Turnstone Technical Operations is a virtual organization, where the majority of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and this role would ideally inspire you to relocate. Most of our virus development team is stationed in Ottawa and most of our partnerships are in Europe – therefore being in Ottawa would be ideal, but if you believe you can be successful in San Diego, we would love to speak with you! This role is best suited for someone with the following:

· 8-10 years of overall experience within the biotech/pharmaceutical industry

· Minimum of 3 years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams

· Scientist or Engineer with advanced degree (PhD strongly preferred but not required)

· Experience with process scale up, deployment and technology transfer of complex biological processes in a GMP manufacturing environment, and process qualification/validation are strongly preferred

· Strong interpersonal skills required

· Proven expertise and technical depth in upstream process development (mammalian cell culture expression systems, ideally for the manufacture of live-viruses), and/or downstream process development is required

· Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry

· Broad exposure to different biological drug products. Experience working with viruses considered a very strong asset.

· Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment

· The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility

· Able to manage competing priorities effectively and adapt to changing priorities

· Analytical and quantitative approach to problem solving, with the ability to self-start and independently investigate technically challenging problems

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:

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 are what we call ‘another Wednesday at Turnstone’? At Turnstone, the science drives decision making, and our drugs are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.

As the Associate Director of Formulation and Drug Product Development, you will provide leadership to a team of Scientists, drive the strategic development plan and direct all Drug Product (DP) and formulation development efforts to support our viral-based platforms (RIVAL). Reporting to the head of viral development, you will:

· Participate as an active member of the Viral Development leadership team, to support overall analytical and process development needs across Drug Substance and Drug Product development

· Manage a cross-functional matrix team (Clinical, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall Drug Product development strategy for a suite of viral-based products

· Provide leadership and guidance to a small team of Scientists

· Drive development of improved viral delivery systems (IV infusion, IT or IM injections) to enable optimization of pharmacy DP handling and administration

· Drive the overall stability program to inform target shelf-life parameters

· Work closely with the Analytical Development team to ensure appropriate and robust assays are in place to enable stability assessments, and drug product characterization

· Lead all aspects of pre-formulation and formulation development across a range of DP images (liquid, and lyophilization)

· Drive to definition of DP critical quality attributes through forced degradation studies and advanced analytical tools

· Support biophysical analytical development and design of characterization studies

· Participation in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdiction as they emerge

Experience & Qualifications:

Turnstone Technical Operations is a virtual organization, where nearly all of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and ideally you feel motivated to relocate for this role to one of those sites. Most of our virus development team is stationed in Ottawa Canada, and most of our partnerships are in Europe – therefore relocating to Ottawa would be ideal, but if you feel you can be successful from San Diego, then let’s chat! This role is best suited for someone with the following:

· 8-10 years of overall experience within the biotech/pharmaceutical industry

· Minimum of 3 years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams

· Scientist with advanced degree (PhD strongly preferred but not required)

· Strong interpersonal skills required

· Experience developing and/or interpreting biophysical analytical methods

· Expertise developing novel formulations (experience developing live virus formulations considered a very strong asset)

· Experience working with drug transfer devices and planning pharmacy handling procedures

· Expertise managing stability programs considered a strong asset

· Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry

· Experience designing, and planning accelerated studies to evaluate degradation pathways and define CQAs

· Excellent computer skills, including Microsoft Excel and Powerpoint

· Able to manage competing priorities effectively and adapt to changing priorities

· Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment

· The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility

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 (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.

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:
Reporting to the Vice President, Clinical Operations, the Clinical Project Manager (CPM) is responsible for the overall management and execution of operational activities involved in the planning, implementation, conduct and completion of clinical trials. This includes management of study deliverables, adherence to budget and timelines, negotiating vendor agreements, approving vendor and Investigator invoices and accruals, and ongoing risk mitigation. The CPM leads and engages with cross functional study teams and stakeholders (program management, site education and monitoring, clinical science, data management, biostatistics, medical writing, medical affairs, regulatory affairs, clinical accounting, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.

Responsibilities:

· Manage and coordinate all aspects of assigned global clinical trials to ensure they are conducted in accordance with established protocols, Company standards (SOPs), ICH/GCP and applicable jurisdiction regulations.

· Identify and manage the identification, evaluation, and selection of external vendors (central lab, CROs, consultants/contractors, etc.) from RFP through budget/ contract negotiations and execution.

· Performs ongoing vendor management to ensure deliverables, high performance standards, and adherence to the contract or change order

· Oversees, manages and reports on project activities, including scope, schedule, budget and risk associated with each assigned project.

· Identifies and tracks key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)

· Develops clinical trial timelines and operational budget, tracks the overall study critical path and manages/oversees all study activities to ensure on-time study delivery.

· Reports study performance and timelines to senior management

· Assists in the identification, selection and initiation of clinical sites

· Oversees the development of required study plans and execution of those plans related to site monitoring, safety management, data management and biostatistics

· Oversees development of CRFs and clinical and safety databases

· Plans, coordinates and conducts investigator meetings globally

· Plans, coordinates and conducts Data Safety Monitoring Board (DSMB) meetings

· With Medical Affairs, assesses trends in data including adverse events, protocol violations, etc.

· Coordinates and manages timely database freeze and database lock.

· Participates in data review meeting.

· Ensures eTMF maintenance in accordance with regulatory standards and requirements

· Assists the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents

· Assists Regulatory Affairs as necessary for IND/CTA filing and other necessary compliance requirements.

· Ensures that clinical operations milestones are prioritized and that team members remain on task to achieve business and departmental goals

· Leads clinical operations meetings with vendors, interdepartmental staff, and alliances.

Experience & Qualifications:

Qualifications:

BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent combination of education and experience
Minimum 2 years of clinical trial/project management experience. Prior experience as a CRA or on-site is preferred, as well
Oncology experience required
Oncolytic virus, cell therapy, or immunotherapy experience is preferred.
Ability to travel internationally or domestically up to 10-20% based on study demands
Excellent working knowledge of GCP/ICH Guidelines
Ability to work effectively independently or as part of a team, remotely or in-office
Comfortable managing multiple projects and ability to adapt to changing priorities
Effective written communication skills and computer skills are required
Strong understanding of Clinical Development
Self-starter and able to “wear many hats” while communicating with a cross-function team in a mid-sized biotech.

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.