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:

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:

As a Technologist within the Virus Development and Manufacturing Sciences Team (CMC), you will assist with downstream process and formulation development, as well as product characterization activities for our virus-based platforms. The responsibilities will include:

Assist in evaluating novel virus purification technologies and scale-up options
Participate in technology transfer and scale-up of downstream/manufacturing processes
Preparation of solutions/reagents and equipment set-up for lab-scale experiments
Perform process characterization studies (e.g. impurity clearance, process limit evaluations)
Execute experiments to assess drug product stability and optimize formulations
Perform studies to evaluate drug delivery systems used in the clinic and test compatibility with product-contact materials (e.g. bioprocessing bags/conatiners, IV bags, etc.)
Ensure compliance to GLP/GDP, and maintain accurate records of all experimental data following GDP
Assist in drafting protocols/LSPs, analyzing data and preparing technical reports
Collaborate with members of the Virus Development and Analytical Development teams to coordinate experiments and testing
Ensure good teamwork and support high-quality deliverables
Perform daily duties to comply with Turnstone’s employment and health & safety and labour policies, procedures and regulations

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

Experience and qualifications

Turnstone has offices in Ottawa, Canada and San Diego, USA. Most of our Virus Development and Manufacturing Sciences team is stationed in Ottawa, and this role will be based in our Ottawa labs. This lab-based role is best suited for someone with the following:

Bachelors or Masters in Biochemical Engineering, Biotechnology or in a related Science field (virology, biology, biochemistry, protein chemistry, pharmaceutical chemistry), with 2+ years of hands-on experience in an academic or industrial laboratory setting
General knowledge of virology, cell biology and protein chemistry
Experience in buffer/solution preparation, experimental data collection/analysis and technical report writing
Experience in virus infection/harvest and mammalian cell culture in adherent and/or suspension bioreactors is considered an asset
Experience in downstream process development, including clarification, chromatography and Tangential Flow Filtration, is considered an asset
Excellent communication (both written and spoken) and interpersonal skills
Ability to manage competing priorities effectively, adapt to changing priorities and function effectively in a fast-paced environment
Ability to work both independently and as part of a team
Excellent computer skills, including 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 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:
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 day 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.

Position Overview:

The Operations team in the Technical Operations department is growing. As the Project Manager Costing, you will report to the Operations Manager, TO. The responsibilities for this position span across our multi-virus and novel cell therapy platforms and will touch several teams across the company:

· Become an expert of the Technical Operations organization’s budget structure and allocation codes

· Act as a liaison between the Finance/Contract teams

· Assist in developing, controlling and maintaining the Technical Operations team budget

· Maintain a master Study Log that tracks Technical Operations invoices, quotes and contracts status to ensure adequate tracking, monitoring and controlling of the team’s budget

· Maintain a master Study Log that tracks study execution milestones to support the monthly accrual process

· Lead the review and approval process for all project work orders and quotes

· Lead the the Purchase Order request process

· Lead the invoices approval and coding processes

· Lead the monthly, quarterly and year end financial close

· Run monthly budget performance reports for projects and key leadership members as needed to help inform business performance

· Assist with communication of the budget performance reports with project managers

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 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.

Experience & Qualifications:

Qualifications:

This role will be located in our Ottawa, Canada or San Diego, USA offices and may require occasional travel between our locations. This role is best suited for someone with the following:

· Experience in participating/developing a small/mid-size organization’s budget

· Experience as a budget coordinator/manager working in a fast-paced organization is preferred

· Technology savviness, fluent using Microsoft Office suite (especially Excel)

· Highly organized, attention to detail, accurate and responsible

· Demonstrated ability to work well independently and as part of a 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

· Ability to multitask, manage several competing priorities and meet deadlines

· The candidate must have mature interpersonal skills, and a communication style that matches the Turnstone style: respectful, transparent, and team-oriented

· Experience within the biotech/pharmaceutical industry would be considered an asset

· Bachelor’s degree in a related Science field considered an asset

· Degree in accounting is considered and asset

· Basic knowledge of molecular biology, cell biology, or virology considered 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:

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 Tuesday 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 technologies are complex and transformative. If you’re a passionate person and our science excites you – this opportunity may be for you.

In this role, you will have the opportunity to lead a team of dedicated and high-performing scientists to direct the full life cycle of analytical assays for GMP release and characterization testing of our platform technologies of novel biotherapeutics. This role will lead a team responsible for assessing technologies to select methods to meet Quality Control needs, leading technology transfer to one of our GMP contract testing organizations, assessing feasibility, performing optimization at the partnering CTO, overseeing qualification, and examining method performance and trending to support ongoing method optimization and improvements. Current products are in early clinical development and so many assays are at the starting line of their analytical life cycle management. This is an opportunity to establish rigorous and far reaching processes for assay qualification and validation, with an eye to phase 3 and beyond. This role will necessitate partnering very closely with many other teams within Technical Operations (Bioprocess Engineering, Manufacturing Sciences, Quality Control, Analytical Operations) to generate assays that are relevant and cutting edge. This role will have elements of technical oversight, helping the team strategize and investigate technical problems, and operational oversight, ensuring that resources are used wisely and the team is supported in their efforts.

We are looking for a scientist that enjoys working as a team and growing as a leader, someone that believes that WHAT we do and HOW we do it are both critical to success. We are looking for a leader that can prioritize a heavy workload, supporting higher level discussions around regulatory implications and employee career development, as well as someone that is willing to roll up their sleeves and pitch in on the ground floor when required. You’ll have experience working with some or all the following, as they relate to analytical development:

Priority areas of interest:
Next generation sequencing and it’s use in GMP environments to support virus genome sequence and variant analysis, adventitious agents detection, and mutanome mapping
Cellular and molecular methods such as virus titering by plaque assay, genome quantitation by qPCR, impurity assessment by ELISA or qPCR, etc.
Engaging in discussions with colleagues on their analytical needs, assessing/investigating various technologies to support those needs, and making decisions on technologies to pursue
Supporting Quality Control scientists in their suspect results investigations to ascertain root cause and path forward
Developing methods to support GMP product characterization or release and supporting the method life cycle management
Planning and leading assay qualification and validation according to principles in ICH Q2, especially as is appropriate to support early clinical development. Experience with method validation considered an asset.
Working closely with external CROs and vendors to drive projects to completion in a timely and scientifically sound manner
· Act as subject matter expert in analytical development during diligence and regulatory interactions

Experience working within GMP quality systems is a must (change control, deviations, corrective and preventive actions, document control)

What’s in it for you?
This role is best suited for a scientist with 8+ years experience in directly supporting analytical method development and qualification in support of GMP clinical product release, leading complex projects, and supporting regulatory submissions. Candidates for this roles will have directly coached and supervised a team of analytical scientists for at least 5 years and worked with external vendors to achieve a project goal. Candidates have achieved either a Masters or PhD in a relevant scientific discipline and are looking to use their knowledge in a meaningful and impactful way, while also learning about new methods, products, and processes. Learning agility is critical as the methods leveraged by the Turnstone CMC analytics team are extremely broad and cutting edge. Candidates have demonstrated the ability to manage both small and large projects, multi-tasking effectively, and having an external presence that is professional, collaborative, and influential.

Travel during the COVID-19 pandemic is highly restricted and unlikely to be necessary. However, upon resumption of regular office life, you will need to travel on occasion to our various vendors (global) and also visit our Ottawa office to stay connected, productive, and excited. This role will report to the Director of Analytical Development and Quality Control at Turnstone. Based on a mutual discussion of fit, the successful candidate(s) will reside at either the Ottawa or New York office location, though consideration will be given to anyone living in eastern North America who is able to travel on occasion (post COVID-19).

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.
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.