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

GCLP 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 products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:

We are seeking a scientist to join the Translational Science team in our growing company and support the development of a next generation personalised cancer medicine. As a GCLP Research Associate at Achilles Therapeutics, you will report directly to the Team Leader Translational Science Operations and work closely with other members of the team to receive, process and store clinical trial samples in accordance with good clinical laboratory practice (GCLP) guidelines.

The successful candidate will have a role in sample receipt and processing, and in carrying out immunoassays. They will ideally have experience working with human blood samples, including PBMC isolation, cell cryopreservation and in flow cytometry. Experience of working in accordance with GCLP or GxP guidelines would be of benefit.

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 independently to receive, process and bank human samples from Achilles clinical trials including during evenings and weekend (Time Off In Lieu system in place)
  • Work in a precise manner with attention to detail at all times
  • Complete all relevant documentation in accordance with GCLP guidelines
  • Organise sample shipping between Achilles sites and to external vendors
  • Carry out immunoassays including flow cytometry and ELISpot
  • Maintain laboratory equipment as required
  • Follow established SOPs
  • Record sample and analysis data accurately

Essential Experience:

  • Undergraduate degree in a biological subject
  • 2+ years hands-on laboratory experience
  • Excellent planning, organisational and time management skills, and attention to detail
  • Good communication and interpersonal skills
  • Self-motivated with strong initiative and drive
  • Ability to work flexibly, including evenings and weekends, as required
  • Proficiency with MS Office

Desirable Experience:

  • Master’s degree in a relevant subject
  • Experience working with human blood samples, including PBMC isolation using density centrifugation
  • Experience with immunoassays including flow cytometry and ELISpot
  • Experience working with liquid nitrogen
  • Practical experience of working with a LIMS system
  • Knowledge/experience of working in a GxP/GCLP environment
  • Knowledge of cancer biology and immunology

This is a permanent position based at the Royal Free Hospital in London, with a competitive salary and benefits package.

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

Senior GMP 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 GMP Quality Associate to primarily perform and support QA duties at a manufacturing site for Achilles product (Investigational Medicinal Product), thereby ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained. The role will also support the separate Achilles Quality Management System, ensuring activities conform to regulatory requirements.

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 Creation, Maintenance and Continuous Improvement of Achilles Quality Management System (QMS) Ensuring Compliance with Regulatory Requirements including Overlap with Catapult Systems
  • Support Operational QA Duties to Ensure GxP Compliance and other Regulatory Requirements Relating to the Manufacturing and Conduct of Clinical Trials
  • Support the Administration of the Company’s Document Management System
  • QA Review and Approval of Procedures, Master Batch Records, and any Other Relevant cGMP Documentation
  • Perform Batch Documentation Review Activities
  • Review Standard Operating Procedures (SOPs) to Ensure Compliance with GMP and Other Relevant Regulatory Requirements
  • Review and Approval of Change Controls
  • Manufacturing Support, Review and Approval of Deviation Investigations, Ensuring Effective Root Cause Analysis
  • Ensuring for Any Investigations Performed that Product Quality, Safety, Efficacy and Compliance Implications are Accurately Assessed. Identification of Repeat Deviations and Assurance that Appropriate Corrective Actions are Taken.
  • Ensure that Deviations, CAPAs, Protocols/Reports and Other Applicable Documents are Approved Within the Designated Timelines.
  • Review and Approve Deviations related to Out of Specification Investigations
  • Work with Teams Across the Business and Externally to Investigate Quality Issues
  • Issue and Review Corrective and Preventative Actions (CA/PAs)
  • Support Complaints Management Process and Where Appropriate Respond to Complaint Investigations
  • Support with Any Qualification & Validation Activities
  • Provide Advice and Guidance to the Wider Team with Support from the QA Manager
  • Perform Internal Audits to Determine Compliance with GMP and Identify Areas for Improvement
  • Perform External Audits as Necessary
  • Support the QA Manager with Hosting Customer Audits and Regulatory Inspections
  • Support Senior Management with the Co-ordination of Recall Activities
  • Support of Provision of In-house Training Activities
  • Provide Support and Data for Achilles Quality Management Reviews

Education and Experience:

Essential:

  • Experience working in QA in a Biotech/Biologics/ATMP GMP Environment – Ideally on MIA /MIA IMP Licensed Site
  • Technical Knowledge of Aseptic Manufacturing Processes, Sterility Assurance and Laboratory Techniques
  • Thorough Understanding of EU and US GMP Requirements
  • Experience within a GMP Quality Assurance Department
  • Experience Investigating Deviations, Complaints, Reviewing Change Controls, Implementing CAPAs and Conducting Internal Audits
  • Experience with Batch and Associated Documentation and its Review

Desirable:

  • Understanding of Clinical Trial Directives/Regulations
  • Knowledge about Regulatory Requirements for ATIMPs
  • Knowledge on HTA Requirements for Cells and Tissues
  • Experience with Environmental Monitoring
  • Experiences with Clean Rooms
  • Experience in a QC GMP Environment
  • Experience with Equipment Qualification Activities
  • Experience with Validation Plans, Activities and Reports
  • Experience of Working with Sponsors, Contract Manufacturing Organisations and Contract Testing Laboratories
  • Experience with Document Preparation/Review in Support of Regulatory Submission Packages
  • Experience Conducting External Audits

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.

FP&A 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 products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:

Reporting to the Senior FP&A Manager, this role is an integral part of the Finance function as it evolves to support the growth plans of the business. The Analyst will work closely with the Senior Manager to ensure that FP&A function oversees a robust budget setting and reforecasting process to manage Board, Investor and other key stakeholder expectations appropriately. Furthermore, the Analyst will be a key business partner providing insights to support decision making and analysis to key business units.

Responsibilities:

  • Accountable for timely and accurate reporting to budget holders across the Clinical, R&D, Manufacturing and Corporate business units. Understanding drivers of month end results and provide meaningful commentary and insights vs forecast/budget
  • Business partner with budget holders to proactively provide finance support on key projects and ad hoc analysis
  • Conduct due diligence analysis on key suppliers and highlight areas of business and financial risk
  • Work closely with Senior FP&A Manager to generate the narrative and insight that forms part of the management, CEO, Investor and Board reporting packs
  • Support the Senior FP&A Manager in the development of annual budget and long-range forecast models
  • Support the Senior FP&A manager in the implementation of a new forecast and planning system

Education and Experience:

  • Degree qualified or equivalent
  • Qualified or part qualified accountant
  • Experience of having worked in a dynamic fast past environment

Skills

  • Ability to thrive in a dynamic and fast-paced environment
  • Strong communicator with the ability to translate technical information into insights and actionable recommendations to non-financial individuals
  • Strong analytical and problem-solving capability with the ability to adapt to an environment with ambiguity or incomplete information
  • Intellectual curiosity to learn about the key drivers of the business and get to the root cause of performance
  • Understands how to support and challenge the business appropriately
  • Highly developed teamwork skills. This role requires working closely across all areas of the business and with other members of the finance team.
  • MS Excel, PowerPoint proficiency

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.

Financial Accountant

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:

An innovative and growing start up business, the organisation is scaling at a fast rate and going through enormous change and Finance is central to this development. Part of this is with the implementation of a robust new control framework. The incoming Financial Accountant will be a key member within the Finance team and play a key part in ensuring controls are working effectively and play a part in their evolution. The Finance department is ambitious and aspires to be best in practice in the way they operate, looking to implement procedures well in advance of them becoming financial reporting requirements

The Financial Accountant will report to the Financial Controller and work alongside the Financial Accounting and Reporting team in owning a number of key operational processes, whilst also playing an integral part in delivering key projects that support the Financial Controller and Financial Director in the wider business.

Responsibilities:

  • Play a crucial part in developing and refining the financial controls to ensure they are designed, implemented and operating effectively
  • Assisting the Financial Controller with the write up of technical workpapers for major accounting cycles in the business in accordance with FRS 102 and US GAAP
  • Assisting with the year end audit and quarterly reviews
  • Support with other ad-hoc projects

Education and Experience:

  • Degree qualified or equivalent
  • Qualified accountant (ACCA, ACA) with at least 2 years PQE
  • Experience of having worked in a recognised and reputable audit and assurance practice prior to working in industry
  • Experience of having worked in a rapidly scaling business is highly desirable

Skills and personal attributes

  • Demonstratable knowledge of working with Financial Systems (the organisation has recently implemented NetSuite)
  • Control orientated mindset appreciating the requirement for financial controls being fulfilled properly
  • Ability to work autonomously as well as part of a team
  • Articulate and numerate • Ability to bring new ideas and solutions to the table
  • Proactive and takes ownership of duties
  • An individual who possesses a high level of integrity and professionalism
  • Excellent written and verbal communication skills.
  • Ability to communicate technical or complex issues with clarity to non-financial individuals

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.

Head of Facilities Management

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 is entering into a period of transformational growth and is increasing its operating footprint to support this. The Company has initiated a programme of works to fit-out its own 24,000 sq. ft. of space at 245 Hammersmith, London which from Q4 2020 will become the Company HQ with state-of-the-art R&D, office and meeting/ collaboration space. To date Achilles has occupied 7,000 sq. ft of serviced office and R&D lab in an incubator environment at the Stevenage Bioscience Catalyst (“SBC”) and has relied heavily on the landlord provided services. Achilles is now seeking a Head of Facilities Management with responsibility across both the new Hammersmith site as well as the existing Stevenage site.

The Head of Facilities Management will provide leadership, ownership and accountability for Facilities Management (“FM”) at the Hammersmith and Stevenage sites, ensuring the business has efficient and effective delivery of services in line with the agreed hybrid operating models. The Head of Facilities Management will be a critical interface for the business developing close and effective relationship with all business functions, in particular R&D and QC, landlords, 3rd party venders as well as leading a high-quality in-house team. Achilles is a vibrant, young and forward-thinking organisation and the Head of Facilities Management will be integral in delivering services in line not only with best practice but in an innovative and environmentally sustainable manner.

The Company anticipates future expansion of the operating footprint both in Hammersmith and Stevenage and the Head of Facilities Management will have a leading role in delivering these projects under the guidance of the appropriate steering groups and working with the technical project teams.

Responsibilities:

  • Responsible for provision of all FM operational services both hard and soft FM at 245 Hammersmith and Stevenage sites in line with the agreed hybrid operating model and industry best practice.
  • Help refine the operating model for 245 Hammersmith and ensure operational readiness is in place for Q4 2020.
  • Attend 245 Hammersmith Steering Group meetings as well as 245 Hammersmith Technical Project Team meetings and take responsibly for a number of workstreams including moves and migrations and operational readiness.
  • Establish and execute a resourcing and people strategy as required to deliver the FM operations for 245 Hammersmith and review the strategy in place for Stevenage.
  • Develop strong relationships with key internal stakeholders throughout the business to support and enable the business.
  • Select and manage third-party vendors to agreed SLAs and get the best out of external teams that should be motivated by and aligned with the Achilles mission.
  • Be the main point of contact with the landlord for both Hammersmith and Stevenage.
  • Working closely with Financial Planning and Analysis (FP&A), develop and manage annual budgets and generate long-range forecasts of operating and capital spend. Achilles will also look to enhance and report on its environmental impact across all its sites.
  • Working with both FP&A, the People team and the wider business, develop models, forecasts and mappings of space utilisation over time across Achilles portfolio of space as the business rapidly grows and ensure there is appropriate headroom in the provision of space for staff.
  • Develop and implement an appropriate service delivery standards framework for Achilles with monitoring of performance in line with professional reporting standards
  • Familiar with BMS systems.
  • Maintain O&M manuals.
  • Ensure FM operations at Stevenage and Hammersmith sites are delivered in line with Health and Safety (H&S) requirements and act as co-ordinator across the business for H&S policy.
  • Manage FM issues with effective escalation and resolution.
  • Drive facilities projects for future operational expansion in both Hammersmith and Stevenage

Education and Experience:

  • Qualifications in engineering or relevant technical field preferred but not essential
  • Ideally a member of BIFM as well as holding a NEBOSH qualification
  • Experience of facilities management at a senior level with demonstrable experience of working with senior stakeholders, people management and vender management.
  • Experience operating in a complex biotech or life sciences environment
  • Experience of thriving in a dynamic and fast-paced environment in an organisation undergoing rapid scale-up
  • Excellent H&S knowledge

Skills and Attributes

  • Able to credibly command the respect and trust of their colleagues through courage integrity and agility with the appropriate gravitas and thought leadership for the facilities function
  • A problem solver will a can-do attitude, positive and proactive
  • Builds high-quality working relationships and actively works through influencing and collaboration
  • Strong communicator with both good presentation as well as written communication skills: someone who speaks in plain English and cuts through excessive jargon
  • Flexible – able to adapt and effectively deal with rapidly changing and stressful situations
  • Strong ownership and delivery
  • Highly organised individual with excellent project management skills
  • Sound judgement – knows when to escalate as required
  • Able to work independently coupled with highly developed team skills.

This is a permanent position 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.

Senior Laboratory 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:

We are seeking an enthusiastic and organised Senior Laboratory Manger. Initially you will be responsible for co-ordinating the set-up of our brand-new Process Development and Translational Science laboratories in London. This will involve communication at all levels within the company to ensure an efficient transition of laboratory work and procedures from our current laboratories in Stevenage to the new location in London. This will involve procurement of new equipment, relocation of some existing equipment, together with equipment installation and qualification. You will be responsible for setting up laboratory operational procedures and oversee the operational management of the laboratories, ensuring that they run smoothly and efficiently in order to enable our team of 30 scientists to continue with the development of a next generation personalised cancer medicine.

Responsibilities:

  • Coordinating set up of new laboratories, including equipment procurement, relocation, and installation
  • Closely involved with project manager to plan the roll out of equipment and services into the lab areas,
  • Working closely with the facilities team to ensure provision of all necessary services to the laboratory areas.
  • Qualification and Validation of equipment, where appropriate.
  • Management of laboratory equipment, including servicing, calibration and maintaining equipment records.
  • Management of temperature monitoring of temperature sensitive equipment
  • Management of a small team of people to ensure labs are well maintained and consumables stocks are re-ordered and replenished
  • Laboratory Health and Safety Management, including creating, reviewing and updating risk assessments and implementing appropriate procedures. Responsibility for everyday lab health and safety.
  • Coordinating and writing Standard Operating Procedures for laboratory equipment and operational processes. Training of staff on these procedures.
  • Provide Laboratory inductions for new starters and ensure they are well informed of laboratory processes and health and safety requirements.
  • Assisting co-ordination of sample shipment and delivery
  • Provide a point of contact for lab staff for queries relating to laboratory equipment and procedures

Education and Experience:

  • Experience of leading a Lab move or setting up Laboratory facilities
  • Experience working within a Biological sciences laboratory
  • Experience working in a Good Clinical Laboratory Practice (GCLP) environment
  • Responsibility for a laboratory of 12+ people
  • Knowledge of laboratory Health and Safety requirements, including COSHH
  • Knowledge of equipment qualification and validation to National Standards
  • Ability to write Standard Operating Procedures at a level suitable for Process Development and Translational Science activities
  • Excellent organisational and time management 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.

 

Clinical Supply Chain Coordinator, Electronic Systems

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:

An exciting opportunity has arisen for a Supply Chain Coordinator to join the Clinical Supply Chain Team. The role will form and integral part of the Clinical supply chain team and will provide support and assistance in the administrative organisation and management of clinical trial projects while ensuring compliance with SOPs and ICH-GCP. The role involves high utilisation of PC, Office, based software packages. A key aspect of the role will involve working with internal and external stakeholders to ensure smooth implementation and delivery of an electronic supply chain platform.

Responsibilities:

  • Work with a selected vendor to set up, implement and maintain an electronic supply chain platform
  • Ensure that the eSupply chain platform is able to be used at scale and fully integrated to meet the business needs
  • To work with internal and external stakeholders to ensure smooth implementation of eSupply chain platform
  • To act as a main point of contact for internal and external stakeholders to ensure smooth day to day running of eSupply chain platform.
  • Track compliance with eSupply chain platform with internal and external stakeholders
  • Act as a main point of contact for troubleshooting and problem solving when eSupply chain platform issues arise.
  • Work alongside SSCC to schedule and manage courier bookings and communications
  • Provide service feedback for vendors to SCM supporting service improvements.
  • Contribute towards building new internal processes and systems within the supply chain team
  • Assist with the preparation and distribution of clinical trial supplies
  • Attend regular clinical project team meetings
  • Update CV and training records as required
  • Any other ad-hoc tasks as required
  • Supporting CTA in any administrative tasks for the clinical operations team as required
  • Responsible for adhering to all health and safety guidance provided by the company

Education and Experience:

  • Clinical Operations experience within an on-site setting
  • Batchelor’s degree (BSc, BA or RN equivalent) in biological or science field preferred.
  • Experience of implementing new electronic systems either in healthcare or pharmaceutical setting
  • Good knowledge of the clinical trial process
  • Good knowledge of ICH-GCP
  • Self-motivated taking personal pride in delivering on personal and corporate objectives
  • Able to interact effectively with individuals at all levels of the organisation
  • Be 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 and dynamic turnaround requirements
  • Microsoft Office skills – excellent proficiency in Word, Excel, PowerPoint and Outlook required

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.

 

Devices QA Associate

About Achilles Therapeutics:

Achilles Therapeutics is a company focussed 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:

  • Support the Design and Development activities related to Achilles proprietary Devices
  • Support the Achilles Quality Management System (QMS) ensuring Device activities conform with regulatory and quality requirements
  • Routine QA duties to ensure GxP and other regulatory requirements relating to manufacture and clinical trials

Responsibilities:

  • QA support of Design Development activities including Design Verification, Design Validation and Design Transfer Activities
  • Review and Approval of Design Plan, Design Verification and Validation protocols and reports
  • Review and Approval of Quality Technical Agreements and Quality Plans associated with outsourced Device activities
  • QA Support of Vendor Selection and Qualification activities associated with Devices
  • Review and Approval of Device owned processes
  • Ownership of QA specific Device processes
  • Support Device History File creation and maintenance
  • Routine QA duties can include activities within the following systems:
  • Document management
  • Creation, review and approve Quality Device and other GxP related documents
  • Deviation management including Risk escalation and investigations
  • Vendor qualification
  • Change Control
  • Corrective and Preventive Action (CAPA)
  • Complaint and Recall handling
  • Training
  • Device Batch Record Review
  • Qualification & Validation
  • Internal Audits and External Audits (as necessary)
  • GxP Data review including technical aspects
  • Support of provision of QA Device GxP and associated in house training activities eg SOPs
  • Provide support and data for Achilles Quality Management Reviews, as required
  • Enhancement of Achilles QMS
  • Work with QA Achilles and Achilles QMS
  • Support activities within Achilles QMS, as assigned

This position requires:

Education:

  • Engineering degree (B.Eng) or equivalent in a closely related scientific subject

 Skills:

  • Demonstrable ability to review and critique Device GxP documents and data
  • Demonstrable ability to write/review SOPs and in compliance with company and global quality and regulatory expectations
  • Technical expertise/knowledge of quality requirements around Device sterilisation and small Device instrumentation
  • Demonstrable ability to work cross functionally fostering Teamwork and Cooperation to achieve quality outcomes and objectives
  • Influencing skills
  • Attention to detail and accuracy in assigned tasks
  • Ability to prioritise workload and work with minimal supervision
  • Good working knowledge of using Microsoft Office programmes
  • Proficient in English Language

Experience:

  • 3+ years working in QA role in a Medical Devices organisation on ISO 13485 licensed site
  • 3+ years working within GMP or closely related Quality Management System
  • Thorough understanding of EU and US Device Quality requirements – 21 CFR 820, ISO13485:2016 and ISO 14971:2019
  • Experience with Risk Management of Medical Devices, from Development phase to clinical use
  • In depth understanding of Medical Device Regulations, 2017/745
  • 2+ years QA experience with ISO 11135 or ISO 11137 requirements
  • 2+ years of experience with Design verification, validation and transfer activities
  • 1+ years of technical knowledge on sterility assurance validation
  • 1+ years of experience with ISO 11607 and ISO 15223 or ISO 1041
  • 1+ year experience with quality requirements relating to small scale Device instrumentation
  • Experience of working with contract manufacturing organisations, design and development organisations and contract testing laboratories
  • Experience with batch and associated documentation and its review
  • Experience with Design History File creation and maintenance
  • Experience with Design Verification, Design Validation, Design Transfer Plans, activities and reports
  • Experience with document preparation/review in support of Technical Files and Regulatory submission packages

Desirable:

  • Experience with ISO 10993 requirements
  • Experience with Medical Device Clean Rooms
  • Experience with Devices that are used for administration or processing of ATIMPs, particularly Cells and Tissues
  • Experience with Point of Care Devices for HCP use
  • Experience with BS EN 60601

This is a permanent position, 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.

Employee Experience and People Operations 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:

The primary purpose of the role is to ensure the smooth running of the people function in order to create great employee experiences.  In order to achieve this you will work closely with the VP People to understand the People Plan and deliver key initiatives that make up the plan.  All activity is aimed at improving the employee experience and you will be the key steward constantly looking to improve the experience of our teams.

You will work across the entire organisation, partnering with managers to enable them and their teams to perform effectively.  The role will see you working in delivery roles joining team sessions across the organisation, running HR processes including employee relations all the way through to doing analysis and reporting, looking for insight to focus our efforts.  As such, you will need to be very adaptable with a growth mindset.

Responsibilities:

Initially, this role will help build the enabling infrastructure that is needed across the organisation.  Indicative projects include:

  • Identifying and implementing an HR Management System
  • Updating and ongoing maintenance of the Staff Handbook
  • Updating and delivery of refreshed approach to Onboarding
  • Development and co-ordination of Management Development Programme
  • Management of annual performance and pay review process

As a growing start-up business, the role will also involve identification of improvements to business processes as well as establishing new ones as the business grows.

Education and Experience:

We work fast and deliver a lot.  To be successful at Achilles, you will be self-motivated, be comfortable dealing with ambiguity and multi-tasking, have excellent interpersonal skills and the ability to build professional relationships.

The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism is essential.

Essential

  • Experience working in a progressive HR / People function
  • Proven experience of running end to end projects across different elements of the HR lifecycle, from scoping to delivery
  • HRIS experience, including the ability to produce reports
  • Employee relations – understanding and practical experience
  • Experience working on an annual pay process including working with benchmark data
  • Able to work under pressure and a real completer finisher
  • Comfortable with data and with a high attention to detail. Competency in using analytics to uncover insights and support better decision making
  • Positive attitude with a solutions-oriented mind-set and excellent problem-solving skills
  • Self-driven and strong use of initiative
  • Able to build strong relationships at all levels, anticipate needs and work successfully with different working styles
  • Excellent verbal and written communication skills, including strong influencing skills
  • Highly organised, with strong prioritisation skills, ability to drive work to conclusions and deliver to deadlines
  • Ultimately, a real desire to learn.

Preferred

  • Degree level education or equivalent
  • Change management experience, ADKAR preferable
  • Experience working with Auditors

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.

Engineering 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.

Summary:
We are seeking an ambitious and engaging Engineering Project Manager to lead and manage large GMP capex projects from concept design through to construction, commissioning and validation.

You will have the opportunity to act as the Achilles point of contact with external Project Management companies and drive the deliverables to ensure on time completion.

This role offers significant visibility with our Leadership teams and is a key and critical hire in the organisational expansion.

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:

  • Provide regular reports and updates to senior management and any relevant Achilles group meetings
  • Be accountable for establishing project plans and timelines for the GMP capex project
  • Serve as the primary point of contact with external collaborators and consultants for the delivery of the project including representing the company at build team project meetings
  • Arrange external and internal meetings, prepare meeting agendas, keep detailed minutes and ensure decisions are actioned
  • Document and track operational deliverables for commercial manufacturing projects

This position requires:

  • Degree in a relevant engineering discipline or equivalent
  • Project management qualification
  • Experience of delivering engineering/capex projects in a GMP environment in life sciences, preferably from concept design through to construction, commissioning and validation
  • Experience of working in cell and gene therapy
  • Excellent interpersonal and organisation skills
  • Ability to work under pressure, prioritise and operate in a fast-paced environment

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.