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.

Strictly no Agencies. Please note that Achilles Therapeutics does not accept speculative applications from recruitment agencies.

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

Achilles has a friendly working environment filled with very experienced and capable individuals with great work ethics and goals. Everyone is always happy to help, and I have gained a lot of knowledge and experience on the job in very little time.

Ornella Caruso

Clinical Trials Administrator

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

Clinical Trials Administrator

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 2H 2019.

Role Summary:
An excellent opportunity has arisen for an experienced Clinical Trials Coordinator to provide support and assistance in the administrative organisation and management of clinical trial projects ensuring compliance with SOPs and ICH-GCP. The position may involve general office administration tasks. This role involves high utilisation of PC, Office, based software packages. The position will be office based. The position offers high value and accelerated learning in the opportunity to experience cross functional aspects of the business and scientific data.
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:
• To provide general administrative and clinical trial support across multiple programs
• To prepare and oversee essential clinical trial documentation and distributing, tracking and filing documents
• To support and oversee with the preparation and distribution of clinical trial supplies
• To create and maintain Project documents and the Trial Master Files (TMF) in accordance with ICH-GCP and company SOPs. To undertake periodic checks on the completeness of the TMF
• To accompany CPMs or CRAs on occasional site visits, if required
• To attend regular clinical and project team meetings, prepares meeting agendas and minutes plus maintains meeting action item lists.
• To provide administrative assistance to the Quality Management team
• To update CV and Training records as required
• Any other ad-hoc tasks as required
• The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company
• To support CPMs in programme related document finalization and contribute to in house self-assessment of scientific data

This is an evolving role and the above list of responsibilities is not exhaustive; the post holder may be requested to assume additional duties, as might reasonably be required. This job description will be reviewed during the annual review process. As the company expands this role has the scope to contribute and manage supply and electronic systems for automation.

This position requires:
• Minimum of three years previous experience of working in Clinical Research or the Pharmaceutical Industry as a Clinical Trials Administrator or similar role
• Bachelor’s degree (BSc, BA or RN equivalent) in biological or science-related field preferred
• Good knowledge of creation and maintenance of Project Files and TMFs
• Good knowledge of the Industry/Clinical trial process
• Good knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice guidelines (ICH-GCP)
• Self-motivated taking personal pride in delivering on personal and corporate objectives
• Able to interact with individuals at all levels of the organisation
• A highly effective communicator, both orally and in writing with an eye for detail and accuracy
• Strong organisational, time management and communication skills
• Ability to act on own initiative within inter-related team and meet deadlines
• Microsoft Office Skills – excellent proficiency in Word, Excel, PowerPoint and Outlook required

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

Senior Clinical Research 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 2H 2019.

Role Summary:
You will be joining a growing, Stevenage based, biotech company which is developing neo­antigen therapy for oncology indications. You would become one of the members of their close-knit team, responsible for all aspects of study site management. It is an ideal role for an experienced CRA who has early phase, oncology study monitoring experience, preferably in the cell therapy arena.

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:
• Expedite the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits
• Conduct Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements regularly
• Independently perform monitoring visits including site initiation, qualification, routine monitoring and close out visits
• Critically review and analyse site activities through frequent visits and contacts to monitor study sites following the applicable study plans and applicable SOPs, to assure compliance with the protocol, JCH and/or FDA GCP Guidelines and other local regulations. This includes but is not limited to: the on-site confirmation of the source data verification of CRFs and Data clarification forms as stipulated
• Manage multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
• Ensure quality of data submitted from study sites, collect data from sites within established timelines and ensure timely follow up/submission on any requested information
• Work across functions in the Company to ensure the readiness of supply kits
• Ensure site compliance, safety and protection of study patients according to the clinical study plans, SOPs, and ICH and/or FDA GCP Guidelines. Work with site personnel/study team to prevent address and resolve issues
• Review adverse event reports (where required) and ensure site reporting of safety events in a timely manner
• Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner
• Interact and build professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers and office-based personnel
• Supervise overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. Provide full support to study sites to facilitate study conduct successfully
• Proactively communicate and escalates with all internal and external stakeholders any serious or outstanding issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
• Ensure documented follow-up to all outstanding issues, within the scope of this position profile. Anticipate and proactively solve study site problems/issues as they occur. Initiate, recommend and communicate corrective actions as needed
• Identify evaluate, and recommend potential investigators/sites on an on­ going basis to assist in the placement of planned clinical studies with qualified investigators
• If required, prepare, coordinate and present at Investigator meetings and other study trainings
• Maintain up to date self-training e.g. ICH GCP and flag new/changes to site and clinical operations team
• Facilitate the Regulatory Compliance audit process, as needed
• Provide monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned
• Uses multiple technologies to foster, maintain, and enhance open communication
• Available for travel up to 60% of the time, including overnight stays as necessary
• Any other ad-hoc tasks as required
• The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company

This position requires:
• Bachelor’s degree (BSc, BA or RN equivalent) in biological or science-related field is essential
• A valid driving license
• Previous small pharmaceutical/biotech experience preferred
• Minimum of 3-5 years’ monitoring experience, working as a CRA.
• Experience in monitoring oncology early phase studies (Experience with ATIMPS an advantage)
Strong clinical technical or disease area expertise (Knowledge of medical terminology and clinical patient management)

Skills/Specialist knowledge:
• Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Excellent communication, interpersonal and organisational skills
• Effective problem-solving skills
• Attention to detail and meet specified timelines
• Computer literacy, proficiency in Microsoft Office. Preferably experienced with the use of eCRFs
• Ability to work independently and to effectively prioritise tasks
• Able to think ahead and anticipate needs before they arise

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

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

Quality 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 product for Non-Small Cell Lung Cancer expected to enter the clinic in 2H 2019.

Role Summary:
We are seeking a Quality Manager who will play a key role in establishing, growing and maintaining the quality systems and processes for the whole organisation which has satellite sites in two other London locations. A hands-on approach is essential and it is expected that the successful candidate will work with the clinical, regulatory and manufacturing teams to implement and develop key documents.
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:
• Set up and manage Achilles QMS ensuring activities conform with requirements
• Perform routine QA duties and audits to ensure GxP & HTA compliance plus other regulatory requirements relating to full oversight of clinical trials for cellular therapies and ATIMPs including:

  • document control system
  • change controls
  • corrective and preventative actions (CAPA)
  • deviation & out of specification (OOS) reporting
  • complaint and recall handling
  • qualification & validation
  • internal and external audits
  • vendor qualification including external audits as necessary
  • working collaboratively with GMP Quality personnel to build a fully integrated Achilles QMSDraft, review and approve Quality and GxP related documentation
  • Identify, prepare and drive the creation and implementation of SOPs and a compliant quality system cross functionally according to company timelines

• Organising provision of GxP training for the company where applicable
• Initiation of a system for, Implementing and Maintaining training records for the company and developing training structures and requirements as the company grows.
• Implementing systems from a quality perspective to ensure ATIMP traceability and responsibility
• Ensuring efficient quality systems supporting logistical aspects product and sample transport and handling
• Advising and approving validation reports and working with the manufacturing team to establish key manufacturing documentation in line with a Contract Manufacturing Organisation’s own QM system
• Has key input into company policies and governance as the company grows
• Support to cross functional teams predominantly clinical ops team in the oversight and execution of global operation systems, in collaboration with GMP quality personnel

This position requires:
• BSc or MSc in a biological subject
• Minimum of 5 years’ experience in developing and maintaining fit for purpose quality systems.
• 5 years’ experience working in a GMP environment or equivalent experience
• Experience in setting up and managing robust Quality Management systems ensure GxP compliance
• Able to lead and build a document management system, writing/supporting SOPs and plans to formulate complete GxP “ground systems” for clinical trial operations
• Experience in planning, managing and executing vendor and site audits
• Good working knowledge of the tissues and cells directive
• Experience of working with contract manufacturing companies
• Experience of auditing key raw material suppliers as to GMP compliance.
• Technical expertise/knowledge of quality requirements for manufacturing processes and laboratory techniques
• English Language skills
• Good working knowledge of using Microsoft Office programs

Desired experience
• A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
• Good understanding of GCP, GCLP, GDP, HTA and data protection requirements
• Experience of training staff

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

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

Principal/Head QC 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 product for Non-Small Cell Lung Cancer expected to enter the clinic in 2H 2019.

Role Summary:
We are seeking a Principal/Head QC Scientist who will lead a small team supporting GMP operations with responsibility for performing all QC related assays for in-process control and final release testing of Achilles T cell therapies (flow cytometric, ELISpot) that are entering the clinic later this year in a phase I/II trial. The candidate will be responsible for developing the strategy of the team with senior members of the company and leading on implementation of all QC documentation and assay validation in line with EU GMP for advanced therapies. In the addition the Principal/Head QC Scientist will lead on supporting both the tech transfer and process development teams on all QC related activity to enable introduction of new manufacturing processes and analytical techniques. As well as developing and growing the team going forward in line with approved budgets.
A hands-on approach is essential, and it is expected that the successful candidate will work with the quality, regulatory and manufacturing teams to implement and develop key documents.
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:
• Manage Achilles QC activities for tech transfer and manufacture of ATMP
• Perform routine QC duties and prepare documentation to ensure GxP & MHRA compliance plus other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATIMPs
• Oversee qualification and validation of equipment and assays
• To review analytical and laboratory data for accuracy, completeness and compliance with documented procedures
• Management of QC compendial testing e.g. endotoxin, mycoplasma, sterility and environmental monitoring.
• Manage junior members of the QC team

This position requires:
• BSc or MSc in a biological subject
• 3 years working in a QC and GMP environment, or equivalent experience
• Technical expertise with immunoassays including flow cytometry and ELISpot
• Experience in qualification and validation of equipment and assays
• Experience in preparing SOPs, Qualification and Validation documents, and other related documentation
• Experience of training and managing staff
• English Language skills
• Good working knowledge of Microsoft Office

Desired experience:
• Knowledge of QC compendial testing (endotoxin, mycoplasma and sterility testing)
• Knowledge of biopharmaceutical and cell-based techniques including immunohistochemistry, PCR, DNA/RNA isolation, cytotoxicity and cell Proliferation Assays.

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.

Bioinformatician

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 2H 2019.

Role Summary:

We are seeking a highly talented and creative Bioinformatics Scientist. 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.
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.

This position requires:

• Recent PhD (or MSc and 2+ years of relevant work experience) in bioinformatics, computational biology, or equivalent
• Good knowledge of molecular genomics and immunology
• Knowledge of advanced statistical & machine learning concepts
• Practical experience of analysing next generation sequencing data (DNA and RNA)
• Authorship on high-quality papers in peer-reviewed journals
• Demonstrated fluency in R and Python
• Experience in reproducible research practices (e.g. dynamic documents, version control & containerization)
• Extensive knowledge of UNIX based operating systems

In addition to the above, you are expected to have:

• Exceptional communication skills
• Demonstrable excellence in problem solving within fixed timelines
• Flexibility and the ability to effectively manage multiple concurrent projects

With the following skills/experiences are desirable:

• Practical experience of oncogenomic, neoantigen and TCR-seq analyses
• Practical experience with cloud-based technologies

This is a permanent position, based in the Stevenage Bioscience Catalyst, with a competitive salary and benefits package.

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

Director of Quality

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 2H 2019.

Role Summary:

We are seeking a bright, enthusiastic and motivated Director of Quality with extensive experience in the field of cell therapy to join our growing multi-disciplinary team and support the development of a next generation personalised cancer medicines. This position will play a key role in establishing, growing and maintaining the quality systems and processes for the whole organisation across multiple sites. The successful candidate will report into the company’s senior management team with responsibilities for setting and reporting on key operational quality targets for the manufacture, testing and supply of advanced therapies for clinical trial. A hands-on approach is essential, and it is expected that the successful candidate will work with the clinical, regulatory, manufacturing and QC teams to implement and develop key documentation for clinical trial applications. 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:

  • Manage day to day activities of the Quality Assurance department and be the reference QA person for all company activity e.g. Document management, Change controls, Qualification & validation and Corrective and preventative actions (CAPA)
  • Be responsible for all quality assurance activities, e.g. GxP (Good laboratory, clinical, manufac-turing, distribution and documentation practices), company SOPs and policies, QA validation activities and compliance training
  • Oversee QA for all GMP activity including batch record review to ensure that controlled docu-ments are followed, standards of quality are maintained, and documentation is complete
  • Preparing for, conducting, and responding to internal and supplier site audits. Identifying ac-tions as a result of internal or external audits, or internal process meetings
  • Participate in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements
  • Organising provision of GCP and GMP training for the company and ensuring procedural train-ing is complete, documented and in compliance
  • Oversee quality assurance planning for study related activities
  • Perform review of quality metrics, CAPA findings and business process improvement opportu-nities, and recommending effective solutions to enhance quality and efficiency, establishing QA processes and standards and compliance related training
  • Ensure systems at partners (critical raw material and service suppliers) are synchronized with current regulations, company’s expectations and quality standards.
  • Raise early signals to risk of business continuity due to any quality issues. Provide direction on mitigation measures
  • Able to lead and build quality management team

This position requires:

  • Advanced degree preferred, e.g. MS or PhD in chemistry, cell biology, pharmacology, pharma-cy or closely related field
  • Minimum of 10 years’ experience in working in a pharmaceutical / biotechnology field devel-oping and maintaining quality systems
  • Extensive experience working in a GMP environment, preferably in the field of ATMPs
  • A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
  • DI or QP experience is desirable
  • Extensive hands-on current experience in a Quality organization within the pharmaceutical and/or biotechnology industries
  • Direct experience in managing Quality, and possess the ability to function effectively as a member of cross-functional project teams with demonstration of leadership skills and ability to work with remote teams
  • Extensive knowledge of QA, CQA, QC, Regulatory Compliance and EU and US requirements for Quality Systems
  • Experience and ability to conduct and lead audits

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

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

DevOps Engineer / Systems Administrator

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 2H 2019.

Role Summary:

We are seeking a talented and enthusiastic DevOps Engineer / Systems Administrator to manage the infrastructure required for developing, validating and deploying our bioinformatics platform, PELEUS™, within the AWS cloud computing environment. This software is a highly specialised automated platform focused on the development of targeted immunotherapies in cancer. The role includes both supporting the use of existing infrastructure and implementing new HPC technologies into the bioinformatics framework.

The successful applicant will have experience as a DevOps engineer in a team developing a software product deployed on a cloud computing environment and be familiar with AWS best practices. You will know how to structure resources and code to ensure that the software is robust and efficient. Your responsibilities will include managing the compute infrastructure, optimising compute resources and working closely with the developers to deliver the next generation of our bioinformatics platform.

This position requires:

• 2+ years of Linux system administration experience, at least 1 of which is with AWS systems
• Expertise with a Linux command line interface
• Experience with job-scheduling systems (e.g. SGE, Slurm, AWS Batch)
• Ability to communicate clearly with a technical and non-technical audience
• Professional experience working in a software development team

In addition to the above, the following skills/experiences are desirable:

• Relevant AWS certification – DevOps Engineer, SysOps Administrator, Certified Developer.
• Experience with Git, source code management (e.g. Bitbucket), issue tracking (e.g. Jira) and continuous integration (e.g. Travis CI).
• Groovy (or Java), R and Python experience
• Familiarity with containerisation environments (e.g. Docker)
• Knowledge of bioinformatics pipeline development
• Comfortable working in an Agile environment

Successful candidates will also possess the ability to take initiative, a desire to work in a dynamic fast paced team environment and an ability to manage multiple, concurrent projects. Prior bioinformatics experience is not required, but a willingness to learn is essential.

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.

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

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

Quality Assurance 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 2H 2019.

Role Summary:

You will be joining a growing, Stevenage based, biotech company which is developing neo-antigen therapy for oncology indications. You would play a key role in establishing, growing and maintaining the quality systems and processes for the whole organisation which has satellite sites in two other London locations. A hands-on approach is essential and it is expected that the successful candidate will work with the manufacturing and QC teams to implement and develop key documents and support of the clinical and regulatory departments in compliance with regulatory requirements and compliance with the company QMS.

Responsibilities:

  • Support the Achilles QMS ensuring activities conform with regulatory requirements
  • Assist in routine QA duties and audits to ensure GxP & HTA compliance plus other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATIMPs including:.
    • document control system
    • change control
    • corrective and preventative actions (CAPA)
    • deviation & out of specification (OOS) reporting
    • calibration and maintenance
    • qualification & validation
    • internal audits
    • vendor qualification including external audits as necessary
  • Develop and review Quality and GxP related documentation
  • Assist in the management of Product Specification Files for ATIMP’s
  • Support the Implementing and Maintaining of training records for the company and training structures and requirements as the company grows
  • Support the implementing of systems from a quality perspective to ensure ATIMP traceability and responsibility
  • Ensuring efficient quality systems supporting logistical aspects product and sample transport and handling
  • Advising in the preparation of validation protocols and reports and review of data generated in the execution of validation protocols
  • Working closely with the manufacturing and QC teams to establish key manufacturing documentation in line with a Contract Manufacturing Organisation’s own QM system

Desirable experience:

  • Working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
  • An understanding of GCP, GCLP, GDP and HTA requirements
  • Experience of auditing key raw material suppliers as to GMP compliance.
  • Experience in vendor and site audits
  • Experience of training staff

Qualifications:

  • BSc or MSc in a biological subject

Successful candidates will also possess excellent communication skills and a desire to solve challenging scientific questions whilst working in a dynamic, fast paced team environment. This is a permanent position, with a competitive salary and benefits package to match seniority and experience. The company has laboratories in London and Stevenage UK and this role is primarily based in London

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

Senior Bioinformatician

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 2H 2019.

Role Summary:

We are seeking a highly talented and creative Senior Bioinformatician to join our team and to contribute to the development of the next generation of immune-based cancer therapies.

The successful applicant will join a small team focused on the expansion and further development of an established bioinformatics pipeline for the identification of clonal variants and prediction of neo-antigens from exome-level sequence data. You will be expected to proficiently benchmark published tools as well as develop novel approaches to the analysis and interpretation of exome sequencing data. 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.

This is a unique opportunity to work with a leading team of scientists with an international reputation for excellence in immune-oncology research and to become a key contributor to an exciting project destined to change the course of cancer patient management in the clinic.

This position requires:

  • PhD in bioinformatics, computational biology, or equivalent and a strong publication record
  • A solid understanding of cancer biology and/or immunology
  • Practical experience of analysing DNAseq data and a broad knowledge of common tools and algorithms
  • Fluent programming skills in R/Bioconductor, Python or Perl

In addition to the above, the following skills/experiences are desirable:

  • Practical experience of in silico neo-antigen detection methods
  • Prior experience analysing RNAseq data
  • Familiarity with software development, version control, and collaboration tools

Successful candidates will also possess good communication skills, a desire to work in a dynamic fast paced team environment and an ability to manage multiple, concurrent initiatives.

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

Job application privacy policy.

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

GMP Production Scientist/Senior Production 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 product for Non-Small Cell Lung Cancer expected to enter the clinic in 2H 2019.

Role Summary:

We are seeking a bright, enthusiastic and motivated GMP production scientist with experience in the field of Advanced Therapeutics Medicinal Products (ATMPs) to join our growing multi-disciplinary team and support the development of a next generation personalised cancer medicines. As a GMP Production Scientist/Senior GMP Production Scientist you will support the technology transfer, validation and clinical production of Achilles Therapeutics ATMP pipeline within the CCGTT GMP clean rooms based at Royal Free Hospital and work closely with the product development team to support process engineering activities. If you want to be a part of a well-funded, exciting new start-up, and enjoy playing an active role in supporting the development and clinical manufacture of ATMPs which have the ability to transform the clinical management of cancer, then this is the role for you.

Responsibilities:

  • Supporting GMP activity for the manufacture of ATMPs to facilitate technology transfer, process validation, equipment validation and qualification, stability studies and materials management
  • Support process engineering activity in closed system cell culture and identifying and implementing procedures in accordance with GMP and regulatory standards.
  • Support continued development and in-process improvement activity to streamline process operations and optimisation of manufacturing methods
  • Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
  • Assist/lead in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product
  • To coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
  • Assist/lead in the maintenance of a laboratory environment suitable for the manufacture of ATMPs
  • Be accountable to the head of production for all production operations

This position requires:

  • BSC/MSC in a Biological Science discipline
  • 3/5 years’ experience in a scientific laboratory role working in a regulated environment (GLP/GCLP/GMP)
  • Experience in human cell isolation, and cell and tissue culture in a GMP compliant environment
  • Able to work in a Grade B cleanroom production environment
  • ATMP Process development experience
  • Understanding of GMP, ATMP, and EUTCD regulations
  • Working knowledge of generating process and QC data for regulatory submissions
  • Strongly focused on quality and safety
  • Have excellent planning and organisational and time management skills
  • Have good communication and interpersonal skills
  • Self-motivated with strong initiative and drive

This is a permanent position, with a competitive salary and benefits package to match seniority and experience. The company has laboratories in London and Stevenage UK and this role is primarily based in London

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