LIFE AT Achilles

At Achilles, we are focused on the development of the next generation of personalised immunotherapies to treat cancer and are dedicated to our patients, who desperately need breakthrough medicines.

We provide extraordinary career opportunities for talented individuals, who will have the opportunity to work with highly experienced leaders in science and business to build an exciting company at the very cutting edge of cancer medicine.

At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership and teamwork. We offer benefits that include competitive salary and performance related bonus, group pension plan, life assurance, private medical insurance and employee share incentive scheme.

If you have what it takes to help build Achilles into a world class immune-oncology company and would like to become a part of our team, please contact: jobs@achillestx.com.

Achilles is an equal opportunity employer committed to a culturally diverse team.

Recruiters and agents must not forward CVs or candidate details to Achilles or any employee of the Company without an explicit, written request from a member of the HR department. We reserve the right to pursue and hire candidate(s) without any financial obligation to the recruiter if their details, which could reasonably identify them, have been passed to the Company without the explicit, written request of a member of the HR department. The agreement of terms in relation to a specific vacancy does not constitute an explicit request for applicants for other advertised roles or speculative applications.

What Our Team Say

I was attracted to Achilles by the ambition of the science that underlies Achilles’ goal. I enjoy the fast-paced environment of a start-up, encountering new challenges on a daily basis. Achilles has a multicultural and cohesive culture with a very strong sense of purpose.

Eleni Kotsiou

Principal Scientist, Process Development

I joined Achilles because I am interested in developing a cancer immunotherapy product with the aim of taking it to clinic. I really enjoy working within a multidisciplinary team and the variety in my role across process development and manufacturing.

Sam Jide-Banwo

GMP Production Scientist

Open PositionsAt Achilles

Senior Scientist

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a motivated, highly talented and creative Senior Scientist. The successful applicant will join a small team within the Process Development department primarily focused on the development of the new generations of T cell therapy products. As a Senior Scientist you will be responsible for establishing strategies to support process development and perform and oversee experimental activities.
The post requires a highly motivated, hard-working and driven individual with extensive experience in immunology, tumour microenvironment, cell culture techniques, multi-colour flow cytometry and immunoassays. Candidates with previous experience in cell therapies are encouraged to apply.
This is a unique opportunity to work with a leading team of scientists with an international reputation for excellence in immuno-oncology research and to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Contribute to the design of novel processes to expand neoantigen reactive T cells
• Perform T cell functional assays and other immunoassays to characterise neoantigen reactive T cells
• High-dimensional flow cytometric data analysis.
• Participate in the Process Development team activities and work in close collaboration with other functions of the company (such as Bioinformatics and Clinical Operations)
• Effectively communicate scientific results to a technical and non-technical audience
• Generating suitable SOPs and following established SOPs
• Complete projects, analyse and manage data, prepare reports and presentations appropriate for internal or external parties within agreed timelines

This position requires:
• A PhD in immunology and 3+ years of relevant work experience or equivalent
• Significant hands-on technical experience in cell culture, flow cytometry and T cell functional assays and in-depth characterisation of immune cells
• Good knowledge of cancer immunology
• Strong sense of urgency and ability to work in a fast-paced environment, excellent planning, organisational and time management skills, and attention to detail
• Dependable and willing to take ownership and responsibility
• Good communication and interpersonal skills

In addition to the above, you are expected to have:
• Experience working with patient blood and tissue samples
• Demonstrable excellence in problem solving within fixed timelines
• Flexibility and the ability to effectively manage multiple concurrent projects

This is a permanent position, based in initially based in Stevenage but relocating to West London in 2020 with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Computational Biologist – Creative Problem Solving

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a highly talented and creative Computational Biologist. The successful applicant will join a small team primarily focused on improving and developing methods to identify neoantigens. You will be expected to proficiently identify and benchmark published tools as well as contribute to the development of novel strategies. You will also design, implement, and apply statistical techniques to analyse and integrate large datasets and work in close collaboration with biologists and clinicians to interpret your analysis results.
In this role, you will have ownership and responsibility for leading large-scale projects focused on delivering creative solutions to challenges across the business. You will have the opportunity to work with creative freedom and utilise innovative technologies.
This is a unique opportunity to work with a leading team of scientists with an international reputation for excellence in immuno-oncology research and to become a key contributor to an exciting project destined to change the course of cancer patient management in the clinic.

Responsibilities:
• Integration and exploratory data analysis of large, complex datasets
• Develop and test hypotheses whilst prototyping analytical approaches/models
• Develop scalable tools
• Effectively communicate analyses to a technical and non-technical audience

Personality Profile:
• Drive
• Resilience
• Creativity
• Ownership

This position requires (Essential):
• PhD
• Experience in bioinformatics, computational biology, or equivalent
• Demonstrated fluency in R and Python
• Experience of advanced statistical modelling
• Experience of Machine learning concepts
• Good knowledge of molecular genomics and immunology

Preferred experiences:
• Practical experience of analysing next generation sequencing data (DNA and RNA)
• Authorship on high-quality papers in peer-reviewed journals
• Experience in reproducible research practices (e.g. dynamic documents, version control, containerization & workflow engines)
• Extensive knowledge of UNIX based operating systems
• Practical experience of oncogenomic, immunogenomic, neoantigen and/or TCR-seq analyses
• Practical experience with cloud-based technologies

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Biostatistician

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
Achilles Therapeutics is looking for an ambitious and skilled Biostatistician to join our Translational Science team. This team is responsible for the development and delivery of analyses that turn exploratory hypotheses into actionable insights from our clinical trials.
The Biostatistics role at Achilles will be pivotal for delivering robust statistical analyses to evaluate exploratory hypotheses in our Translational Science program.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Work within the multidisciplinary Translational Science team and forge strong links with other teams at Achilles to facilitate best practice for the analysis of our biological datasets.
• Model and integrate biological datasets from a variety of sources (e.g. NGS, proteomics and Flow Cytometry) to evaluate our existing hypotheses and guide the future direction of the Translational project.

This position requires:
• Recent PhD (or MSc and 2+ years of relevant work experience) in Biostatistics, or Bioinformatics with a high component of statistical training
• Demonstratable experience in handling, modelling and drawing inferences from large volumes of biological datasets
• Authorship on high-quality papers in peer-reviewed journals
• Demonstrated fluency in either R or Python
• Knowledge of UNIX based operating systems and prior use of cloud computing resources
• Very strong communication skills in order to convey statistical analyses
• Exceptional time management agility to manage concurrent projects
• A clear ability to develop robust data analyses to fixed timescales

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Bioprocessing Engineer

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a bright, motivated and enthusiastic Bioprocess Engineer with experience in immunological cell culture and associated laboratory techniques. As Bioprocess Engineer, you will report directly to the Senior Bioprocess Engineer and Senior Process Validation Scientist, working on collaborative projects which will help to automate and scale our clinical manufacture process. You may also work closely with the Manufacturing and Process Development teams, translating and transforming investigative research-scale projects into GMP.
This is a unique opportunity to work with a leading team of scientists and engineers with an international reputation for excellence in immuno-oncology research and to become a key contributor to an exciting project designed to revolutionise the clinical management of cancer.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Immunological cell culture
• Carry out immunoassays including multi-parameter flow cytometry and ELISpot
• Design, optimise and develop assays to characterise Achilles cNeT product
• Generate SOPs in accordance with existing standards
• Support planning and execution of verification and validation activities
• Effectively communicate results, and implications, to technical and non-technical audiences
• Work on collaborative projects to automate clinical manufacture process, including use of devices and bioreactors
• Complete projects, analyse and manage data, prepare reports and presentations appropriate for internal or external parties within agreed timelines

This position requires:
• Undergraduate/Master’s degree in Biochemical/Bioprocess Engineering or Biotechnology.
• laboratory/industry experience.
• Experience developing/translating processes suitable for GMP manufacture.
• In-depth knowledge of immunology/ATMPs/Cell therapies
• Experience with Cell Therapy bioprocessing, including development and/or manufacture.
• Hands-on experience with closed-system bioreactors and/or devices for bioprocess automation and scale-up
• Demonstratable process development/problem solving skills
• Excellent planning, organisational and time management skills, with a proven ability to work in a fast-paced environment.
• Excellent communication and interpersonal skills

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Junior Project Manager

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and melanoma expected to enter the clinic in 1H 2020.

Role Summary:
You will be joining a growing, London based, biotech company which is developing neo-antigen therapy for oncology indications. You would become one of the leaders within their close-knit team, responsible for coordinating and managing allocated studies. Ideal for a LCRA, UK CTM or aCPM/jCPM making the transition into cell therapy from Biotech who already has early phase oncology and or cell therapy experience.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.
Play a pivotal role in our Clinical Operations team leading clinical studies within a programme. Act as an expert in your therapy area, working independently and then supported as necessary based on an individual development plan.
This position will have key relationships with internal stakeholders within the clinical project team and will have clearly defined responsibilities working alongside the sCPM, as well as externally with KOLs, investigators and external service providers/vendors.

Responsibilities:
• Create/Review patient consent forms and provide relevant opinion
• Have responsibility for delivery of components of clinical trials
• The overall efficient day-to-day clinical trial management of studies
• Manage and support start up activities for UK clinical trials sites including negotiation of contracts, site selection and review of essential regulatory documentation
• Manage timeline adherence, site budget adherence in conjunction with the sCPM and project quality deliverables
• Interact with and day to day management of vendors including supporting sCPM with vendor budget oversight
• Manage contract requirements
• Perform occasional interim monitoring visits, including site qualification, initiation and close-out, including the source data verification of CRFs and Data clarification forms as stipulated
• Co-ordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements
• To maintain Project documents in accordance with ICH-GCP and company SOPs and support the transition from paper to eTMF
• Develop and update with oversight of the sCPM study plans and documents, including the Project Plan, Monitoring Plan, Deviation Plan
• Collaborate with site teams and CRAs to drive recruitment and high quality data collection
• Prepares and support material preparation for external meetings, other study trainings and project meetings as required
• Be prepared to travel nationally for the role

This position requires:
• Strong clinical study experience in Oncology and or cell therapy.
• Excellent collaboration and communication skills.
• Knowledge of medical terminology and clinical patient management. ICH GCP trained.
• UK clinical trial experience in a senior or lead role
• Previous experience of site monitoring in early phase oncology studies ideally in melanoma or NSCLC
• Experience with ATIMPs an advantage
• Bachelor’s degree (BSc, BA or RN equivalent) in biological or science-related field is essential
• Skills/Specialist knowledge
• Thorough knowledge of ICH-GCP guidelines and UK legislation.

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Senior Scientist

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a motivated, highly talented and creative Senior Scientist. The successful applicant will join a small team within the Process Development department primarily focused on the development of the new generations of T cell therapy products. As a Senior Scientist you will be responsible for establishing strategies to support process development and perform and oversee experimental activities.
The post requires a highly motivated, hard-working and driven individual with extensive experience in immunology, cell therapy, cell culture techniques, multi-colour flow cytometry and immunoassays. Candidates with previous experience in process development and cell therapies are encouraged to apply.
This is a unique opportunity to work with a leading team of scientists with an international reputation for excellence in immuno-oncology research and to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Contribute to the design of novel processes to expand neoantigen reactive T cells
• Perform T cell functional assays and other immunoassays to characterise neoantigen reactive T cells
• Participate in the Process Development team activities and work in close collaboration with other functions of the company (such as Bioinformatics and Clinical Operations)
• Effectively communicate scientific results to a technical and non-technical audience
• Generating suitable SOPs and following established SOPs
• Complete projects, analyse and manage data, prepare reports and presentations appropriate for internal or external parties within agreed timelines

This position requires:
• A PhD in immunology and 3+ years of relevant work experience or equivalent
• Significant hands-on technical experience in small- and large-scale immune cell isolation, cell culture, flow cytometry and T cell functional assays
• High dimensional flow cytometric data analysis
• Good knowledge of cancer immunology
• Strong sense of urgency and ability to work in a fast-paced environment, excellent planning, organisational and time management skills, and attention to detail
• Dependable and willing to take ownership and responsibility
• Good communication and interpersonal skills

In addition to the above, you are expected to have:
• Experience working with patient blood and tissue samples
• Demonstrable excellence in problem solving within fixed timelines
• Flexibility and the ability to effectively manage multiple concurrent projects

This is a permanent position, based in initially based in Stevenage but relocating to West London in 2020 with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Head of Clinical Operations US

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a Head of Clinical Operations to establish and build operations through North America. The Head of Clinical Operations (US) is responsible for the delivery of the clinical development program (initially two studies with scope to build out further studies) to agreed budget timelines and quality metrics. The person will also lead data management activities across programs to ensure that clinical outputs are of consistently high quality.

Responsibilities:
• Work closely with the VP, Clinical Operations and Director Clinical Operations EU.
• Responsible for the delivery of the clinical development program initially two studies with scope to build out further studies
• Lead data management activities across programs to ensure that clinical outputs are of consistently high quality
• Ensure compliance in all aspects of tissue procurement shipment and storage and ATIMP management and delivery for clinical trials in North America
• Direct line management accountabilities to build a team including clinical project managers, CRAs and CTAs, and will ensure adherence to established guidelines, standards and SOPs. The Head of Clinical Operations will ensure that individual clinical projects are adequately resourced in conjunction with the VP, clinical operations
• A senior member of the Clinical Operations Team
• Ensure adherence to GCP and other rules/regulations as appropriate
• Ensure Vendor contracts are “workable” and accurate. Ensure in-house tracking systems
• Work with a Quality manager (consultant or in-house) to ensure SOPs, forms & templates are ready and current for clinical use
• Support CPMs for processes of Site level approvals /Ethics/MHRA submission and maintenance (UK and EU)
• CT management plans – ensure current and fit for purpose
• Performing Site initiations (where required), overseeing clinical trial and escalation point for vendors by CPM
• Oversee the process of Serious Adverse Events, ensuring medical review and reporting requirements are met
• Vendor assessment and selection in conjunction with VP Clinical Ops
• Oversee and ensure contract process for vendors and study sites, supporting the CPM for the indication
• Co-ordinate and lead CPMs for preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.

This position requires:
• Knowledge and/or experience with cellular therapies preferred
• Science, medical or pharmacy degree in relevant discipline at BSc level or higher
• At least five years of experience in clinical trial management, preferably in a biotechnology environment
• Experience with cellular therapy, individualized therapy, and/or ATMPs (desirable)
• Experience working in Oncology trials
• Proven experience in clinical trial management in a relevant organisation
• Demonstrated ability to manage early phase clinical trials
• Experienced in working with a CRO, and being responsible for oversight, support on routine events to the CPM in tasks assigned to the CRO
• Judgement and problem-solving abilities to identify solutions to routine issues and seek guidance on more complex issues
• Strong interpersonal skills with ability to build consensus and work effectively in teams

This is a permanent position, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Purchase Ledger Assistant

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first product for Non-Small Cell Lung Cancer expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a highly motivated and positive thinking to act as Purchase Ledger Assistant. You will be responsible for processing supplier invoices and staff expenses. This will involve liaising closely with all parts of the business to ensure appropriate approvals are in place as well interacting with key suppliers to resolve queries. The Purchase Ledger Assistant will provide an indispensable service to the finance team and business and will underpin business critical systems and processes.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Maintaining the purchase ledger in Netsuite including inputting all supplier transactions and staff expenses.
• Ensuring all invoices and expenses are authorised in line with Company policy and accounted for in line with accounting standards and VAT rules.
• Liaising with company suppliers, setting up new suppliers and reconciling monthly supplier statements.
• Matching invoices to purchase orders and goods in notes on the online purchasing system.
• Preparing regular payment runs.
• Undertaking any other reasonable duties, commensurate with the job title, as may be determined by their line manager.

This position requires:
Essential
• Previous experience and the ability to demonstrate appropriate skills and knowledge
• Excellent numeracy with an ability to spot numerical errors
• Good verbal and written communication skills
• Intermediate excel skills with experience of maintaining spreadsheets
Desirable
• Netsuite experience
• Good understanding of VAT
• Experience of working in life sciences and biotech

Personal Attributes:
• Individual of the utmost integrity who commands the respect of others and is able to represent the Finance function
• Attention to detail
• Meticulous and methodical
• Proactive
• Flexible and willing to work in the fast-paced changing environment of an ambitious biotech start up

This is a permanent position, that will be initially based in Stevenage and relocating to West London in 2020, with a competitive salary and benefits package.
Please send your CV with a covering letter by clicking Apply.

Regulatory and Clinical Development Associate

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first product for Non-Small Cell Lung Cancer expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a highly motivated and positive thinking science or technology graduate looking to step into a highly rewarding multi-disciplinary role supporting the regulatory affairs and clinical development functions. This is a fantastic opportunity to gain experience in both functions with a rapidly growing biotech environment alongside industry experts and will offer the successful candidate the potential to develop their specialism in either regulatory affairs or clinical development in the future.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
Including but not limited to:
• Supporting the Chief Medical Officer and Director, Regulatory Affairs in day-to-day duties
• Supporting submissions to regulatory authorities
• Maintaining regulatory and clinical project plans and tracking documents
• Assisting with specific clinical and regulatory projects and participating in meetings
• Preparation of communication materials
• Organising meetings with Key Opinion Leaders (KOLs), Regulatory Authorities and other senior staff

This position requires:
• Appropriate BSc or higher qualifications; including Life Science related degrees (Biology, Chemistry, Medicine, Pharmacology), Engineering or Device Technology related degrees, Computer, Data Science or Data Automation related degrees, Economics, Statistics, Data or Mathematics related degrees
• Ability to work with a team and able to use own initiative
• Positive and can-do attitude
• Able to demonstrate commitment

This is a permanent position, based in London, with a competitive salary and benefits package.
Please send your CV with a covering letter by clicking Apply.

GCP QA Associate

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a highly motivated GCP Quality Associate to primary perform and support QA duties with respect to Achilles Clinical Trial Activities and Science Research Studies. This will involve maintenance of the Quality systems and processes for Achilles Quality Management System (QMS), thereby ensuring compliance to applicable regulatory requirements.
Duties ensure that the clinical trials / studies sponsored by Achilles Therapeutics are conducted according to the ICH GCP standards and other applicable regulatory requirements, so that the rights, safety and well-being of trial subjects are protected, and that clinical trial data sets are credible.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Support the Quality Manager & Quality Director in the set up/ management of Achilles QMS ensuring activities conform with requirements.
• Perform routine QA duties to ensure GCP & HTA compliance plus other regulatory requirements relating to oversight of clinical trials for cellular therapies and ATIMPs including: Document control system; Change Controls; Corrective and Preventative actions (CAPA); Deviation and Investigation management; Vendor Qualification; Compliance audits; Internal and External audits (as necessary); Complaint and Recall handling
• Draft, review and approve Quality and GCP related documentation that support clinical projects and programmes;
• Author, review and approve SOPs, WIs, as required;
• Serve as QA representative on cross functional project teams, as required;
• Perform vendor assessments covering suppliers and subcontractors of GCP related services and/or clinical laboratory testing services (GCLP);
• Working collaboratively with GxP Quality personnel and cross functionally to assist in building a compliant, fully integrated Achilles QMS;
• Participate in cross functional investigations, assure root causes (s) are identified and document with effective CAPAs in place to reduce occurrence;
• Organise and provision of GxP training for the company where applicable;
• Provide support and data for Achilles Quality Management Reviews, as required;
• Help develop and maintain Quality metrics and lead initiatives to improve performance;
• Maintain Quality Tracking Logs, as required
• Support logistical aspects, starting material, sample and product transport and handling.
• Support to cross functional teams predominantly the clinical operations team in the oversight and execution of global operation systems, in collaboration with GCLP and GMP quality personnel.

This position requires:
Education

• Scientific Degree – B.Sc. or M.Sc. or equivalent in Chemistry, Biology or Pharmacy or closely related subject;

Skills

• Excellent attention to detail and identify, mitigate quality issues/discrepancies
• Demonstrable ability to review and critique GxP documents and data
• Demonstrable ability to work as part of a team
• Demonstrable ability to work consistently, flexibly and independently
• Effective written and oral English Language communication skills;
• Good working knowledge of using Microsoft Office programmes;
• Demonstrable ability to perform multiple tasks and prioritise work to assure business and compliance objectives are met

Experience

• Minimum of 3 years’ experience working in a GCP environment or equivalent QA background;
• A good understanding of Good Clinical Practice (GCP) including the regulatory framework, 2005/28/EC and associated directives and UK SIs;
• Experience in writing SOPs/WIs/forms and reviewing clinical documentation such as protocols, plans and reports;
• Experience in planning, managing and executing internal and vendor audits;
• Good understanding of GCP, GCLP, HTA and data protection requirements;
• Experience of working with contract research organisations and/or clinical operations;
• Experience of training staff

Desirable
• Good working knowledge of the Tissues and Cells Directives 2004/23/EC, 2006/17/EC and 2006/86/EC and their associated UK SIs;
• Experience with document preparation/review in support of regulatory submission packages

This is a permanent position, that will be initially based in Stevenage but relocating to West London in 2020, with a competitive salary and benefits package.
Please send your CV with a covering letter by clicking Apply.