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

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

Legal Counsel

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 an in-house Legal Counsel to provide a broad range of legal support to Achilles across all business activities, including R&D, manufacturing, clinical, regulatory and corporate functions, and to work with senior executives and other stakeholders within the company on critical business initiatives.
This is a fantastic opportunity to join a dynamic, innovative company where you can make an impact from day one. As the sole in-house Legal Counsel you will be highly driven, and someone who thrives when given the opportunity to take ownership for key operational processes and stakeholder relationships.

Responsibilities:
• Leading or participating in the negotiation and drafting of strategic and commercial contracts across all business areas, including CDAs, MTAs, clinical trial agreements, licensing and collaboration agreements, service agreements, consultancy and employment contracts
• Providing advice on a variety of legal issues, such as contract and employment law, risk mitigation and potential disputes, intellectual property and trade secrets
• Ensuring compliance with all laws and regulations that apply to the business
• Promoting legal, compliance and risk management best practice throughout the company
• Selecting and establishing an electronic contracts management system and electronic signature software
• Managing use of external law firms as appropriate
• Providing training for the company on relevant legal topics

This position requires:
• Relevant experience in a law firm or in-house department, preferably representing clients in the life sciences industry in corporate or commercial matters
• Strong interpersonal and presentation skills, along with the ability to communicate effectively with others at all levels of the organization
• Excellent strategic and negotiation skills regarding legal and commercial issues
• Ability to assess business risks and find pragmatic solutions within ethical and legal boundaries
• Demonstrated ability to work autonomously
• Ability to establish and maintain strong relationships across all departments
• Law degree from a recognised university
• Admitted to practice in the UK
• Undergraduate and/or post-graduate degree in a relevant field (e.g. biochemistry, immunology, pharmacology, genetics or bioinformatics) would be advantageous but not essential

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

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:
We are seeking a highly motivated and committed Research Associate. The successful applicant will join a small team within the Process Development department primarily focused on gene editing of immune cells. The work will be carried out at Achilles Therapeutics in Stevenage in collaboration with Prof Sergio Quezada’s team at University College London, benefiting from their deep expertise in tumour microenvironment and immune modulation.
The post requires a driven individual with experience in immunology, flow cytometry and cell culture techniques. 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:
• Hands-on gene editing work
• Contribute to evaluation of gene edited cells
• Follow established SOPs
• Participate in the Process Development team activities
• Effectively communicate scientific results.

This position requires:
• Degree in Immunology/Biology or relevant field (e.g., gene editing)
• 2+ years hands-on laboratory experience
• Experience with immunoassays including flow cytometry
• Good planning, organisational and time management skills, and attention to detail
• Good communication and interpersonal skills
• Self-motivated with strong initiative and drive

In addition to the above, you are expected to have:
• Experience working with patient blood and tissue samples
• Knowledge on tumour immunology or gene editing
• Master’s degree in a relevant subject.

In addition to the above, the following skills/experiences are desirable:
• Experience with gene editing techniques (e.g., CRISP/Cas9)
• Practical experience on genetic manipulation of cells (knock down and overexpression)
• Experience with functional T cell assays (eg ELISPOT, killing/ proliferation assays)

This is a two year fixed term position, based in Stevenage, 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 product for Non-Small Cell Lung Cancer expected to enter the clinic in 2H 2019.

Role Summary:
We are seeking a committed, highly talented and creative Senior Scientist. The successful applicant will join a small team within the Process Development department primarily focused on gene editing of immune cells. The work will mainly be carried out at Achilles Therapeutics in collaboration with Prof Sergio Quezada’s team at University College London. Prof Quezada’s team has great expertise in tumour microenvironment and immune modulation and the successful applicant is expected to work at both the Achilles Therapeutics labs and Quezada labs (Stevenage and UCL respectively).
The post requires a highly motivated, hard-working and driven individual with extensive experience in immunology, immune-regulation, multi-colour flow cytometry, molecular biology and cell culture techniques. Candidates with previous experience in mouse models of cancer, PDX and cell therapies are specifically encouraged to apply for this position.
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:
• Develop/optimise gene editing protocols
• Contribute to design and analysis of neoantigen reactive T cells in a PDX model
• Participate in the Process Development team activities
• Effectively communicate scientific results to a technical and non-technical audience
• Generating suitable SOPs and following established SOPs
• Analysis and maintenance of data

This position requires:
• A PhD in immunology or relevant field (e.g., gene editing) and 3+ years of relevant work experience or equivalent
• Significant hands-on technical experience in flow cytometry and T cell functional assays
• Experience with gene editing techniques (e.g., CRISP/Cas9)
• Practical experience of genetic manipulation of cells (knock down and overexpression)
• Good knowledge of tumour immunology
• Excellent planning, organisational and time management skills, and attention to detail
• Authorship on high-quality papers in peer-reviewed journals
• Holding a Home office licence

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

In addition to the above, the following skills/experiences are desirable:
• Experience with humanised mice and PDX models
• High-dimensional flow cytometry data analysis

This is a two year fixed term position, based in Stevenage and London, with a competitive salary and benefits package.

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

Principal GMP 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 well-qualified and experienced candidate to join our growing manufacturing team at Achilles Therapeutics to support the scale up of manufacturing for the Company’s personalised T cell therapy products for use across Achilles clinical trial programmes. As a Senior GMP Production Scientist you will support the technology transfer, validation and clinical production of Achilles advanced therapies and also working 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.
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.

Key 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
• To assist/lead in the preparation and review of GMP documentation including BMRs, SOPs, Change Control, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability
• 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
• Work with external service providers
• Be accountable to the head of production for all production operation
• Provide support and supervision for junior GMP production scientists

This position requires:
• BSC/MSC in a Biological Science discipline.
• 5 years’ experience in a scientific laboratory role.
• Minimum of 3 years’ experience 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 validation 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, based at Achilles HQ in Stevenage with the opportunity to work with the Achilles manufacturing team established at The Royal Free Hospital in London. This position offers a competitive salary and benefits package.

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

Head of GMP Production

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 well-qualified and experienced candidate to join our growing manufacturing team at Achilles Therapeutics to support the scale up of manufacturing for the Company’s personalised T cell therapy products for use across Achilles clinical trial programmes. As Head of GMP Production you will support the technology transfer, validation and clinical production of Achilles advanced therapies and also working 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.
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.

Key Responsibilities:
• Leading GMP activity for the manufacture of Achilles advanced therapy platform and 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
• To assist/lead in the preparation and review of GMP documentation including BMRs, SOPs, Change Control, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability
• Lead operations for 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
• Ensure maintenance of GMP cleanroom environment suitable for the manufacture of ATMPs
• Work with external service providers
• Provide support, leadership and supervision for GMP production scientists

This position requires:
• BSC/MSC in a Biological Science discipline.
• 10 years’ experience in a scientific laboratory role.
• Minimum of 5 years’ experience 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 validation 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, based at Achilles HQ in Stevenage with the opportunity to work with the Achilles manufacturing team established at The Royal Free Hospital in London. This position offers a competitive salary and benefits package.

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

GMP 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 well-qualified and experienced candidate to join our growing manufacturing team at Achilles Therapeutics to support the scale up of manufacturing for the Company’s personalised T cell therapy products for use across Achilles clinical trial programmes. The GMP Quality Manager will play a key role in establishing, growing and maintaining the quality systems and processes to support the expansion of operations for GMP production. A hands-on approach is essential, and it is expected that the successful candidate will work with the clinical, regulatory, QC 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.
Key Responsibilities:
• Support Quality Director in build of Achilles QMS, ensuring activities conform with requirements
• Perform routine QA duties to ensure GMP & HTA compliance plus other regulatory requirements relating to manufacture of Autologous ATIMPs including:
o document control system
o change controls
o corrective and preventative actions (CAPA)
o deviation & out of specification (OOS) reporting
o complaint and recall handling
o calibration and maintenance
o qualification & validation
o internal and external audits including vendor /supplier qualification
o batch record review prior to QP certification
o Draft, review and approve Quality and GxP related documentation
o Manage Product Specification Files for ATIMP’s
• Reviewing and approving validation protocols and reports and working with the manufacturing team to establish key manufacturing documentation
• Selection and implementation of eQMS to support GxP activities and wider business
• Key input into QMS policies and plans

This position requires:

• 7+ years’ experience in developing and maintaining regulated quality systems.
• 5+ years’ experience working in a pharmaceutical GMP or Medical equivalent environment
• 3+ years working in Quality role on MIA/MIA IMP or HTA licenced site
• Experience in ATIMPs and/or aseptically manufactured product
• Experience in setting up and managing robust GxP compliant eQuality Management systems
• Able to write/author SOPs, WIs and plans/reports to support clinical trial manufacturing operations
• Demonstrable experience in planning, managing and executing vendor, raw material and site audits
• Experience of working with third party contract manufacturing and testing organisations
• Experience with Clean rooms and ISO14644 requirements
• Demonstrable experience in Facility, Systems and Equipment qualification activities
• Technical expertise/knowledge of quality requirements for manufacturing processes and laboratory techniques
• Pragmatic, hands on approach with operational mindset
• Good English Language reading, writing and communication skills
• Good working knowledge of using Microsoft Office programmes

This position also requires:

• BSc or MSc in a chemical or biological subject
• Formal auditor qualification is desirable
• DI experience is desirable
• Thorough understanding of HTA requirements and Tissues and Cells Directive
• 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 requirements
• Experience of training staff and building and managing small team
• Experience with Clean room and facility design
• Experience with Clinical manufacturing operations
• Ability to manage multiple projects and prioritise to support business
• Ability to work independently with minimal supervision or guidance

This is a permanent position, based at Achilles HQ in Stevenage with the opportunity to work with the Achilles manufacturing team established at The Royal Free Hospital in London. This position offers a competitive salary and benefits package.

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

Principle 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:
The Principle QC Scientist 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 Principle 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.

Key Responsibilities:
• Work closely with the Head of GMP Production and The Director of Quality to establish operations. Processes and systems for QC capabilities
• Manage Achilles QC activities for tech transfer and clinical trial manufacture
• Perform routine QC duties and prepare documentation to ensure GxP & MHRA compliance plus other regulatory requirements relating to the manufacture and of Achilles advanced therapies
• Oversee qualification and validation of equipment and assays
• Select, purchase and qualification of appropriate QC laboratory equipment
• 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 oversee environmental monitoring activities
• Help build, support and manage junior members of the QC team
• Establish and maintain relationships with external QC providers

This position requires:
• 5 years working in a QC and GMP environment, in a pharma/biotech environment
• Technical expertise with immunoassays including flow cytometry and ELISpot
• Experience in qualification and validation of equipment and assays
• Strong understanding and demonstrable experience of the application of GxP requirements including design and implementation of SOPs, Qualification and Validation documents required for a regulated environment
• Experience of training and managing staff
• 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
• 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, based at Achilles HQ in Stevenage with the opportunity to work with the Achilles manufacturing team established at The Royal Free Hospital in London. This position offers a competitive salary and benefits package.

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

Business Analyst

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 a Business Analyst reporting to the Director of Business Operations to provide competitive intelligence and external insights support. The position will be office based.

Responsibilities:
• Collect, track and document competitive intelligence
• Conduct and report analyses on competitive landscape and benchmarking against peer companies
• Synthesize effectively collected competitive intelligence data for communication to senior management and potentially create user-friendly visualization tools for this purpose
• Prepare weekly newsletter on competitive intelligence
• Maintain and update sample tracking databases supporting the Director of Business Operations
• Provide support to arising company projects and lead cross-functional initiatives
• As required provide ad hoc support to senior management including CEO
• The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company

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.

Skills, Experience and Personal attributes:
• Experience in competitive intelligence and/or benchmarking gained directly within a consulting firm or other relevant company
• Proven experience in managing and leading projects
• Undergraduate degree in biological or science-related field
• Strong understanding of pharmaceutical R&D in oncology and ideally in cell therapy
• Strong knowledge of publicly available and subscription resources for competitor and/or benchmarking information
• Experience in presenting analyses and insights to senior stakeholders
• 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
• Strong analytical skills
• Ability to act on own initiative within inter-related team and meet deadlines
• 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.

eTMF Specialist

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 eTMF Specialist, responsible for implementing, owning and managing the eTMF (Electronic Trial Master File) system. We are looking to have the successful candidate in position by the end of 2019.

Responsibilities:
• Work with a selected vendor to set up, implement and maintain an eTMF (Trial Master File);
• Work with third party vendors to ensure that the eTMF platform and electronic data platform is able to be used at scale and fully integrated to meet the business needs.
• Manage and run the eTMF in accordance with the DIA reference model and be responsible for the oversight of compliance alongside quality functions and data privacy requirements
• Collect, coordinate and maintain essential documents and ensures the completeness of the Trial Master File (TMF) for assigned clinical studies
• Propose quality standards and oversee compliance;
• Respond to problems and assist in implementing corrective and preventive actions;
• Support the ongoing use of the CTMS
• Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files.
• Contribute towards building new internal processes and systems within the clinical operations team to support the company’s growth
• Ensure inspection readiness

Education and Qualifications:
Bachelor’s degree or equivalent in life sciences or allied health fields such as nursing, pharmacy or health science.

Skills, Experience and Personal Attributes:
• Experience of either leading or involvement in the implementation of an eTMF system
• Experience of initiating, managing, running and maintaining an eTMF system
• Relevant clinical research experience in industry or in clinical practice as a trial/study coordinator
• Good understanding of GDPR and data privacy requirements
• Experience of working with patient tracking systems, financial tracking systems, archive document systems,
• Good understanding of how internal IT systems interface with external vendor systems
• Experience of working with current ICH/GCP guidelines
• Highly PC literate; able to learn and get up to speed with new IT systems as needed
• Good planning and organisational skills with strong attention to detail
• Good verbal and written communication skills
• Excellent team player
• Highly self-motivated with a “can do” attitude
• Positive and enthusiastic approach to work
• Flexible and able to respond to changing work priorities and mutli tasking
• Embraces change and happy to work in a growing and changing organisation

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.

GMP 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 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
• Support 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.
• Assist in the preparation and review of GMP documentation including BMRs, SOPs, Change Control, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability.
• 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 in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product.
• Coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
• Be accountable to the head of production for all production operations.

Desirable Experience
• MSC in a Biological Science discipline.
• 5 years’ experience in a scientific laboratory role.
• 3 years’ experience 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.

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