Careers

We are based in Stevenage at the Stevenage Bioscience Catalyst, London at the Royal Free NHS Foundation Trust and Munich and are looking to expand our team.

We provide extraordinary career opportunities for talented individuals, who will have the opportunity to work with highly experienced leaders in science and business with proven track records in building successful businesses. Our success depends on the quality, experience and ambition of the individuals that join our team.

 

LIFE AT FREELINE

If you have what it takes to help build Freeline into a world class gene therapy company and would like to become a part of our team, please contact: recruitment@freelinetx.com

Freeline is an equal opportunity employer committed to a culturally diverse and international team.

Strictly no agencies. Please note that Freeline does not accept speculative applications from recruitment agencies.

U.K. VACANCIES

Business Support Assistant

Job Location:

Stevenage - SBC

Description:

Freeline is a privately-held clinical-stage biotechnology company based in the UK and Germany. We have an ambitious vision to create better lives for people suffering from chronic systemic diseases using gene therapy as a one-off curative treatment. Freeline has a clear focus on gene therapy (AAV) targeting the liver with the aim to provide treatments for diseases with significant unmet patient needs.

Our gene therapy treatment builds upon the pioneering, world renowned work by the Freeline CSO, Professor Amit Nathwani. His award winning scientific work has already been life changing for patients with Haemophilia B by making gene therapy safe, effective and reliable.

Innovation and entrepreneurial spirit is at our core, but our passion is working together as one team and tangibly making life changing impact. We are therefore looking for talented and passionate professionals who are driven and team orientated. If you share our vision for excellence and are looking for a high paced work environment you may be a great fit for our team.

The Business Support Assistant will provide day to day support and assistance to the VP Research and VP Finance & HR in a fast-paced environment. The role will also have responsibility for general office duties and facilities management. This is a demanding and varied role and requires someone who is efficient, has a sense of urgency and a positive, ‘can do’ attitude.

Role and Responsibilities
  • VP diary management, travel arrangements and expenses
  • Co-ordinates management and team meetings including preparation of agenda, room booking, greeting visitors
  • Working with hiring managers and HR Manager to arrange interviews, liaise with recruitment agencies, greet candidates
  • Ensure smooth running of office – ordering office supplies, IT equipment, kitchen provisions, taking phone calls, reporting any issues e.g. equipment breakdown
  • Supporting new starter/onboarding process
  • Point of contact for Stevenage Bioscience Catalyst (SBC)
Qualifications & Experience:
  • Self-motivated, resilient and able to organise own workload
  • Experience of working in a similar role – supporting cross functional teams where priorities are often conflicting
  • Strong interpersonal skills – builds wide and effective networks at all levels
  • Good attention to detail
  • MS Office expertise

Job Reference Code:

20072018

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Scientist/Senior Scientist- Biochemistry Assay Development

Job Location:

Stevenage SBC

Description:

Freeline is a privately-held clinical-stage biotechnology company based in the UK and in Germany. Our vision is to create better lives for people suffering from chronic systemic diseases using the potential of gene therapy as a one-off curative treatment. Freeline has a clear focus on AAV based gene therapy targeting the liver with the aim to provide treatments for diseases with significant unmet needs.

We recently opened our brand new state-of-the-art laboratory at the Stevenage Biosciences Catalyst, a short 20-minute train journey north of London. Our recent series B funding round of £88M has enabled the recruitment of exceptionally talented Scientists, who will drive their projects using the best available or novel cutting-edge technologies.

Our gene therapy treatment builds upon the pioneering work by the Freeline CSO, Professor Amit Nathwani, Professor of Haematology at UCL which has already transformed the lives of patients by providing safe, effective and reliable gene therapy for people with Haemophilia B (NEJM papers 2011 and 2014 links are mentioned below).

Our proprietary AAV capsid is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein. This strong capsid performance is being validated in the haemophilia B patients and sets the stage for potentially curative products in a wide range of disease which have not to date been treatable with one-time treatment.

http://www.nejm.org/doi/full/10.1056/NEJMoa1108046

http://www.nejm.org/doi/full/10.1056/NEJMoa1407309

 

ROLE AND RESPONSIBILITIES

We are seeking a highly motivated and enthusiastic hands-on Scientist to join the Biochemistry group at Freeline. Exceptional candidates with significant experience may be considered at the senior level. The Scientist will be an emerging or established leader that will lead Assay Development and Validation efforts across the entire Research Department, which encompasses all pre-clinical pipeline programs. It is expected that the Scientist will also collaborate with CMC to transfer assays that may support clinical development. The Scientist will have unlimited opportunities to collaborate with multi-disciplinary teams within the Research Department and the support to shape their own career development path. The successful candidate will lead challenging and rewarding research projects in an environment that relies on tenacity, perseverance and collaboration.

 

Specifically, the successful candidate will:
  • Lead the development and validation of novel activity, kinetic and functional assays (e.g. fluorogenic, chromogenic, macromolecular such as SPR, FRET)
  • Lead the development and validation of antibody-antigen based assays (ELISA in the simplest form but HTRF, TRF and/or FP experience is considered an asset)
  • Planning and hands-on throughput of biochemical/biophysical and antibody-based assays to support pipeline discovery efforts
  • Identification and implementation of novel biochemical/biophysical techniques through rigorous and regular review of scientific literature and developments in the field
  • Write project summaries and reports and adhere to standard record keeping practices
  • Collaborate with other internal teams, especially CMC, to develop translational preclinical assays to support clinical development
  • Support work involving external collaborations and Contract Research Organisations
  • Support line manager in a matrix team environment, and in ensuring smooth running of the group.
  • Set an example to other colleagues, and to train and mentor junior staff in appropriate techniques
  • For experienced candidates, supervision of one or more Research Associates/Scientists and the potential to lead pre-clinical programs

 

QUALIFICATIONS & EXPERIENCE
  • A PhD-degree in Biochemistry or relevant biological discipline or equivalent level of professional qualifications
  • Hands-on experience with ELISA, activity/functional assays is essential
  • High-throughput assay development experience is strongly preferred.
  • Experience in assay validation, preferably in industry, is strongly preferred
  • Demonstrated ability to independently analyse, interpret and present data in a clear manner
  • Highly collaborative Scientist with excellent communication and inter-personal skills
  • Evidence of scientific accomplishments in the form of publications, patents and/or presentations.
  • Strong critical, scientific, and strategic thinking skills; problem solving and decision-making abilities.
  • Demonstrable ability to work in multi-disciplinary, diverse teams

Job Reference Code:

18072018

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Scientist – Capsid Development

Job Location:

Stevenage - SBC

Description:

Freeline Therapeutics Ltd. is a privately-held clinical-stage biotechnology company based in the UK and in Germany. Our vision is to create better lives for people suffering from chronic systemic diseases using the potential of gene therapy as a one-off curative treatment. Freeline has a clear focus on AAV based gene therapy targeting the liver with the aim to provide treatments for diseases with significant unmet needs.

Our gene therapy treatment builds upon the pioneering work by the Freeline CSO, Professor Amit Nathwani, Professor of Haematology at UCL which has already transformed the lives of patients by providing safe, effective and reliable gene therapy for people with Haemophilia B.

Our proprietary AAV capsid is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein. This strong capsid performance is being validated in the haemophilia B patients and sets the stage for potentially curative products in a wide range of disease which have not to date been treatable with one-time treatment.

Role and Responsibilities

We are seeking a highly motivated, enthusiastic and skilled individual with an excellent track record to join the Capsid Development Program to contribute to the discovery of our next AAV-based gene-therapy medicines capable of changing the treatment paradigm. Scientist positions at Freeline are designed to provide a strong research foundation that is supported by our newly created state of the art facility based at Stevenage, UK. In addition to leading research within Freeline you will have opportunities to establish collaborations with external groups.

The research group at Freeline places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. We will provide you with promising and exiting research projects in an environment that strongly values your development.

  • Contribute to establishing a pipeline for the discovery, development, and screening of novel AAV capsid variants.
  • Execution of preclinical AAV studies using various in vitro and in vivo model systems related to AAV capsid development; delivering high-value data and supporting all aspects of AAV-based gene therapy across projects
  • Execute and write up scientific experiments in a timely manner and with high quality
  • Partner with other internal teams, especially CMC, to develop translational preclinical packages for novel capsid candidates.
  • Support work involving external collaborations and Contract Research Organisations (CROs).
  • Identification and development of new AAV applications and to keep up-to date with the scientific literature and developments in the field
  • Set an example to other colleagues, and to train junior staff in appropriate techniques
  • Provide project summaries and reporting, as required and to adhere strictly to established quality standards, accurate record keeping always, essential for on-going activities
  • Promote and suggest implementation of new methods, technologies and processes to ensure best practice
  • Support line manager in a matrix team environment, and in ensuring smooth running of the group.
Qualifications & Experience:
  • A PhD-degree in a relevant biological discipline or equivalent level of professional qualifications
  • Scientific training and background in one or more of the following areas: Cell and gene therapy, preparation of peptide display/variant libraries, novel barcoding and next generation sequencing techniques, bioinformatics, high through-put screening assays for AAV variants.
  • Strong knowledge in molecular biology and bioinformatics, and previous experience in AAV vector production is highly desirable.
  • Excellent verbal and written communication skills are essential.
  • Evidence of scientific accomplishments in the form of publications and presentations.
  • Strong critical, scientific, and strategic thinking skills; problem solving and decision-making abilities.
  • Experience interpreting and presenting data to internal and external stakeholders, and meetings
  • Demonstrable ability to work in multi-disciplinary, diverse teams

Job Reference Code:

05072018

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External Supply Manager

Job Location:

SBC - Stevenage, UK

Description:

Freeline Therapeutics Ltd. is a privately-held clinical-stage biotechnology company based in the UK and in Germany. Our vision is to create better lives for people suffering from chronic systemic diseases using the potential of gene therapy as a one-off curative treatment. Freeline has a clear focus on AAV based gene therapy targeting the liver with the aim to provide treatments for diseases with significant unmet needs.

Our gene therapy treatment builds upon the pioneering work by the Freeline CSO, Professor Amit Nathwani, Professor of Haematology at UCL which has already transformed the lives of patients by providing safe, effective and reliable gene therapy for people with Haemophilia B (NEJM papers 2011 and 2014 links are mentioned below).

Our proprietary AAV capsid is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein. This strong capsid performance is being validated in the haemophilia B patients and sets the stage for potentially curative products in a wide range of disease which have not to date been treatable with one-time treatment.

Role and Responsibilities:
  • Oversee day to day management of technology transfers to external parties & ensure ongoing compliant supply, maintaining timelines & tracking budgets
  • Plan & ensure secure compliant supply of critical materials for the FLT portfolio (both internal & external GMP production)
  • Identification, documentation of potential risks and mitigations and monitoring of progress
  • Produce and distribute status, resourcing, and tracking reports
  • Lead technology transfer teams and as tech transfer lead, play a key role in CMC matrix teams delivering the overall CMC/supply for Freeline’s development projects
  • Act as technical/supply lead for post-tech transfer projects.
  • Oversee activities focused on manufacturing support & trouble-shooting (across all stages of manufacture including aseptic processing and fill/finish) for investigation of process failures, quality incidents, deviations, corrective/preventative action plans, and change controls
  • Perform root cause investigations and work with multidisciplinary teams in developing and implementing solutions; identification of potential timeline & project challenges
  • Build expertise in aseptic processing, fill-finish, inspection and packaging to support in-house and third-party contract manufacturing operations, providing guidance on best practices to improve aseptic processes and procedures
  • Responsible for FLT team authoring, reviewing, and approving technical reports, manufacturing instructions, process validation documents, and corresponding portions of regulatory submissions, supporting licensing processes at new manufacturing sites
  • Engage cross-functionally to identify and communicate standards and best practices for process design and manufacturing
  • Define success criteria for tech transfer & provide expert evaluation of the technical outcomes. Provide Input to regulatory submissions for in-house projects.
  • Work closely with cross-functional teams focusing on continuous improvement and operational excellence, improving efficiency and effectiveness
  • Assist with effective meeting management both internally and with third parties
  • Keep the CMC Project Director informed of all project communication and status of project and risks
  • Ensure project progress according to quality standards, SOPs, GxPs and relevant guidelines to fulfil all regulations
  • Assist in the negotiation and contracting process with contract organisations
Qualification, Education and Experience Requirements
  • Bachelor’s degree, (Masters/PhD/EngD) in either life sciences, biotechnology, chemical engineering, or related discipline
  • Knowledge and experience of bioprocess development, scale-up and GMP manufacturing (including large scale mammalian cell culture support)
  • Experience in biopharmaceutical/biologics manufacturing and/or process development/scale-up
  • Experience of developing robust and scalable GMP compliant processes for either gene therapy, viral vectors, vaccines, or biological products; including knowledge spanning upstream; downstream and fill/finish technologies
  • Experience of technology transfer, management of CRO’s/CMOs and/or GMP manufacturing, providing technical expertise to assist troubleshooting issues, during technical transfer or routine production
  • Knowledge of quality management and regulatory requirements
  • Experience in pharmaceutical industry with a minimum of 3-5 years in GMP Manufacturing
  • Experience working in a cross-functional CMC team on a gene therapy, biopharmaceutical or vaccines project and demonstrable understanding of the technology and technical challenges
  • Experience of CMC development or regulatory affairs would be an advantage
  • Comprehensive understanding of the drug development process from development through to market
  • Demonstrable ability to work in and lead multi-disciplinary, multi-cultural teams and work effectively with partners
  • Ability to travel to work partners in Globally as the role requires
Preferred Skills
  • Excellent interpersonal skills, negotiation skills, and facilitation skills
  • Ability to work well autonomously and within a multi-disciplinary virtual team environment
  • Demonstrates strong analytical and problem-solving skills
  • Ability to scope, develop, manage and deliver projects
  • Management and tracking of budgets
  • Excellent verbal and written communication and computer literacy skills
  • Effective time management
  • Management of third party providers and contracts
  • Regulatory and Scientific Writing
  • Ability to deal with and manage uncertainty

Ability to use Microsoft PowerPoint and Project Manger

Job Reference Code:

03072018

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Senior Research Assistant

Job Location:

Stevenage

Description:

A unique opportunity has arisen for a Senior Research Assistant to join a cell & gene therapy company based in the Stevenage area. The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe.

The research group at Freeline places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. We will provide you with promising and exiting research projects in an environment that strongly values your development.

You will join the cell and gene therapy Discovery & process development team. You will work independently and as part of a team under the close supervision of their line manager.

Basic qualifications:

  • BSc in a relevant biological discipline or equivalent level of professional qualifications with at least three years of Laboratory experience
  • Prior experience in cell culture techniques (primary cultures and cell lines) and transduction/transfection assays using viral and non-viral approaches.
  • Demonstrated ability to perform routine analytical tests to support ongoing process development studies: assays include ELISA, Enzyme activity assays, cell-based assays, and various plate-based assays.
  • Demonstrate ability to interact effectively within a multi-disciplinary team and to prioritise work across multiple projects and respond effectively as priorities changes
  • Attention to details and good communication and timely completion of laboratory notebooks and documentation will be expected.
  • Compliance with health, safety, environmental and quality standards and procedures.
  • Ability to learn specific practical techniques and apply this knowledge to solve problems.

Preferred qualifications

  • Prior knowledge on the execution of preclinical AAV studies using various in vitro and in vivo model systems related to AAV gene therapy development and deliver high-value data and support all aspects of AAV-based gene therapy projects.
  • Understanding of one or more areas of the following: cell biology, cell co-culture systems, cell-based assays, ex vivo tissue processing and histology.
  • Broad knowledge of the drug discovery process.

This is fantastic opportunity to join a company who are passionate about the gene therapy sector and who are at the forefront of expanding the industry. The team is small, fun and promotes fast-learning! To find out more please contact recruitment@freelinetx.com.

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SCIENTIST

Description:

A unique opportunity has arisen for a Scientist to join a cell & gene therapy company based in the Stevenage area. The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe.

The research group at Freeline places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. We will provide you with promising and exiting research projects in an environment that strongly values your development.

You will join the cell and gene therapy Discovery & process development team. You will work independently and as part of a team under the close supervision of their line manager.

ROLE AND RESPONSIBILITIES

  • Execution of preclinical AAV studies using various in vitro and in vivo model systems related to AAV gene therapy development and deliver high-value data and support all aspects of AAV-based gene therapy projects
  • Executes and write up scientific experiments in a timely manner and with high quality
  • Partner with other internal teams, especially CMC to develop translational preclinical packages for gene therapy clinical candidates.
  • Support work involving external collaborations and Contract Research Organisations (CROs).
  • Identification and development of new AAV Applications and to keep up-to date with the scientific literature and developments in the field
  • Set an example to other colleagues, and to train junior staff in appropriate techniques
  • Provide project summaries and reporting, as required and to adhere strictly to established quality standards, accurate record keeping always, essential for on-going activities
  • Promote and suggest implementation of new methods, technologies and processes to ensure best practice
  • Support line manager in a matrix team environment, and in ensuring smooth running of the group.

Basic qualifications:

  • h.D. in Biomedical Sciences
  • Scientific training and background in one or more of the following areas: Cell and gene therapy, Cell biology, transfection and transduction experiments for in vitro candidate screening.
  • Hands on experience performing and analysing biochemical/molecular biology assays.
  • Exceptional communication skills and demonstrated ability to work effectively as part of a team.
  • Evidence of scientific accomplishments in the form of publications and presentations.
  • Strong critical, scientific, and strategic thinking skills; problem solving and decision-making abilities.
  • Experience interpreting and presenting data to internal and external stakeholders, and meetings
  • Demonstrable ability to work in multi-disciplinary, multi-cultural teams

Preferred qualifications

  • Experience working in a commercial/industry environment is preferred but not essential
  • Understanding of one or more areas of the following: advanced cell biology, in vitro disease modelling, cell-based assays, co-culture systems, ex vivo tissue processing and histology.
  • High-level knowledge and experience AAV gene therapy
  • Broad knowledge of the drug discovery process.

This is fantastic opportunity to join a company who are passionate about the gene therapy sector and who are at the forefront of expanding the industry. The team is small, fun and promotes fast-learning! To find out more please contact recruitment@freelinetx.com.

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In-vivo Research Assistant

Description:

Background information for the position. Freeline is a biopharmaceutical company focused on the development and commercialization of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform developed by Amit Nathwani, Professor at UCL and CSO of Freeline Therapeutics. Freeline is fast progressing simultaneously several programs towards clinical investigation and is now establishing a new Discovery Laboratories to ensure the rapid translation of our innovative vectors into clinic benefit. We have an existing opportunity for an In- vivo Research Assistant to be part of a truly innovative research in gene therapy to develop our next generation of therapeutics.

The position within the Research Department –  We are seeking a highly motivated, enthusiastic individual to contribute to the discovery of our next AAV-based gene-therapy medicines capable of changing the treatment paradigm.

In-vivo Research Assistant positions at Freeline are designed to provide a strong research foundation that is supported by our newly created state of the art facility based at Stevenage, UK.

The in vivo work will be carried out at Royal Free Hospital/UCL, London, UK and most of the ex vivo studies would be performed at our new facility in Stevenage, UK.

The selected candidate will actively support pre-clinical research programs by assisting and implementing in-vivo and in-vitro experiments as well as in-vivo pharmacological data generation; handling dosing, sample collection, performing accurate data collection/ in vitro-ex vivo assays and reporting with supervision.

The research group at Freeline places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. The candidate will be working on promising and exciting research projects in an environment that strongly values development.

Candidate profile, role and requirement. We are seeking individuals whose profiles will include:

  • Bachelor’s Degree w/ 1-3 years of laboratory & animal work experience/Home office Personal License (Module 1-4 certification)
    Or
    3 – 5 years laboratory & animal work experience/Home
    office Personal License (Module 1-4 certification) are required.
  • Competence in rodent handling and various routes of drug delivery are essential
  • Experience in basic laboratory techniques, including Immunohistochemistry, ELISA, WB, PCR, cell staining and possibly FACS.
  • Experience in rodents breeding & genotyping is desirable but not essential

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Project Manager

Job Location:

SBC – Stevenage, UK

Description:

Role and Responsibilities

  • Provide project planning expertise to assigned projects and programs from Development through to Market to ensure alignment of program strategy with operational delivery
    • Oversee day to day management of projects
    • Create and manage project plan, maintain timelines, identification of critical path
    • Budget and resource planning and tracking
    • Identify opportunities to accelerate activities or to increase efficiencies
    • Proactive identification of opportunities and potential risks and mitigations and monitoring of progress
  • Support the Project Leaders and work-stream leaders in the day to day management of assigned projects, providing status updates and escalating issues and risks
  • Coordinate all functions to ensure the appropriate level of communication and identification of project inter-dependencies to achieve key development, regulatory and commercial milestones
  • Serve as a core member and drive efficient operation of the Project Team including organization of meetings, agendas, preparation of minutes and maintenance of project management documentation such as decision, issue and actions logs
  • Ensure that team deliverables and key performance indicators are realistically set and tracked according to governance endorsement and that the project effectively fulfils all business reporting requirements.
  • Produce and distribute status, resourcing, and tracking reports
  • Assist with effective meeting management both internally and with 3rd parties; organization of project team meetings and preparation of minutes
  • Contribute to preparation of reports and presentations to support project team meetings and governance reviews
  • Conduct lessons learned reviews of projects to identify best practice and key areas for improvement
  • Input to development of process and procedures to support the Program Management function, communicate project and portfolio status and secure efficiencies and dissemination of best practice across the portfolio.

Qualification, Education and Experience Requirements

  • Scientific background and educated to degree level at least, preferably post-graduate
  • Project Management qualification or accreditation
  • Experience in (bio)pharmaceutical/biotech industry (minimum 5 years preferably 10) with a minimum of 3 years (preferably 5) in Project Management
  • Significant experience working in cross-functional project teams on a gene therapy, biopharmaceutical or vaccines project and understanding of the technology and technical challenges
  • Comprehensive understanding of the drug development process from development through to market

REQUIRED SKILLS

  • Excellent interpersonal skills, communication skills, and facilitation skills
  • Strong analytical and problem solving skills in order to decipher and integrate cross-functional project information
  • Ability to work well autonomously and within a multi-disciplinary virtual team environment
  • Ability to scope, develop, manage and deliver cross functional projects
  • Results focussed with ability to prioritise across multiple projects and deliverables
  • Good attention to detail with ability to keep sight of the overarching project and programme objectives
  • Strong skills with MS Project and in building detailed project plans, defining dependencies and critical path
  • Management and tracking of budgets and resource utilisation
  • Excellent verbal and written communication and computer literacy skills
  • Effective time management
  • Ability to travel to work partners in Europe and US as the role requires

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QA Manager

Job Location:

Stevenage, UK

Description:

1. Role and Responsibilities

  • Lead QA support for GMP manufacturing activities in Freeline’s GMP module at the Catapult Cell and Gene Therapy Manufacturing Centre in Stevenage
  • Provide QA oversight of work executed at third party GMP manufacturing and testing service providers
  • Provide QA input into Change Controls, Deviations, OOS reports and CAPAs
  • Lead Quality investigations and perform risk assessments
  • Review of CMC sections of regulatory filings
  • Conduct external audits of GMP service providers
  • Review of executed batch manufacturing, QC and stability records
  • Review and approval of qualification, validation and tech transfer activities
  • Assist with coordination of vendor assurance programme
  • Perform preliminary batch record review prior to batch certification by QP
  • Quality representative for specific projects
  • Working with Manufacturing and Quality Control to determine appropriate specifications
  • Conduct internal audits of manufacturing and testing facilities and processes
  • Support Competent Authority inspections (MHRA and US FDA)
  • Assist with any recalls or customer complaints

2. Qualification, Education and Experience Requirements

  • Educated to degree level or equivalent in a biological or physical science
  • Experience in Quality Assurance in the pharmaceutical/biotech industry, minimum 6 years GMP experience with minimum 2 years in biologics.
  • Demonstrates a thorough understanding of biologics or ATMPs manufacturing for clinical development.
  • Prior experience auditing contract manufacturers and suppliers
  • Excellent planning and organisational skills
  • Ability to work in a small team in a dynamic environment
  • Significant experience and/ or familiarisation with Microsoft Office applications (specifically Word)
  • Ability to travel to work partners in Europe and US as the role requires
  • Excellent interpersonal skills
  • Excellent verbal and written communication and computer literacy skills
  • Effective time management
  • Strong analytical and problem-solving skills
  • Proficient with Microsoft Excel and Powerpoint

3. Preferred Skills

  • GCP/ GCLP experience
  • Qualified Person (QP) status would be an advantage but not essential
  • Experience implementing electronic document management systems

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Patent Counsel, Biotechnology

Job Location:

Stevenage

Description:

New Appointment – ‘Make a difference every day’

Patent Counsel, Biotechnology – Stevenage

Freeline® is a clinical-stage biotech company focused on the development and commercialisation of gene therapies based on a next-generation AAV gene therapy platform developed by Professor Amit Nathwani. The company is rapidly advancing several programs simultaneously by building a state-of-the- art manufacturing platform for AAV.

Established and funded by Syncona, Freeline is based at the Stevenage Bioscience Catalyst (SBC) just north of London and also has facilities in Munich, Germany. The SBC is a national and European hub of cell and gene therapy development, and the Catapult Cell and Gene Therapy manufacturing facility recently opened on site.

The ambition of the growing company and the pace of activities in an intensely competitive field have given rise to this appointment of a second in-house patent attorney, to be based in Stevenage. This is a fantastic opportunity for a commercially-oriented attorney to join and make a real impact every day at a critical period in the company’s trajectory, in one of the hottest fields in medicine. In doing so the successful candidate will gain a first-hand insight into the workings of a 21st-century biotech company and become an expert in patenting cutting-edge gene therapies. The candidate will be exposed to all facets of in-house practice and will be empowered with substantial autonomy and responsibility.

The Role – the candidate will:

  • Be the second member of the IP Department, reporting to the Director of IP.
  • Liaise closely with the R&D and project teams and collaborators to identify potentially patentable subject-matter.
  • Have a critical role in building the company’s patent portfolio; draft and prosecute applications and be involved with their defence at opposition stage and beyond.
  • Evaluate FTO of the company’s activities.
  • Work with outside patent and legal counsel on prosecution, advisory and contentious matters.
  • Assist the Director of IP in areas such as devising and implementing internal IP processes; corporate and investment-related activities; internal education and training.

The candidate will:

  • Possess an excellent first degree in a biotechnology-related discipline; a PhD is advantageous.
  • Be a qualified EPA and CPA working as a biotech/life science attorney with direct client experience, preferably with some ‘in-house’ experience.
  • Be proficient at drafting and prosecution; opposition/ contentious experience and opinion work is advantageous.
  • Be commercial in mindset and personable in nature; enjoy interacting with the business and varied stakeholders.
  • Be hard-working and proactive, willing to take ownership for areas of responsibility, and comfortable working in a dynamic, agile and un-bureaucratic environment.
  • Be motivated by the prospect of being part of a highly talented multi-disciplinary group all pulling together to overcome the challenges to realising the company’s ambition.

APPLICATIONS: Please contact Marlow IP Recruitment Ltd on either +44 (0)1423 522838 or (0)203 0512123 or alternatively email your CV to Graham Marlow, Managing Director quoting reference number 2085; graham@marlowiprecruit.com.

All third-party applications will be forwarded to Marlow IP Recruitment for assessment.

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Senior Scientist Quality Control

Job Location:

Stevenage, Hertfordshire

Description:

Freeline Therapeutics (“Freeline”), is a biopharmaceutical company focused on the development of gene therapies for bleeding and other monogenic debilitating disorders, based in the United Kingdom.

Freeline was launched in December 2015 with an initial £25 million Series A financing from Syncona LLP continuing with series B financing this year. Freeline is based at the Stevenage BioScience Catalyst and the Cell and Gene Therapy Catapult GMP Manufacturing Centre, Stevenage. Freeline also owns the German laboratory facility Freeline Therapeutics GmbH.

The Company’s next-generation AAV gene therapy platform has been developed by Professor Amit Nathwani, Founder and Chief Scientific Officer of Freeline and Professor of Haematology at University College London. The platform is founded on the successful haemophilia B phase I/II trial conducted by his group with St. Jude Children’s Research Hospital. The results of the study, published in the New England Journal of Medicine, demonstrated that all ten of the treated haemophilia B patients showed safe, sustained expression of blood clotting Factor IX following a single treatment.

As part of building our team to drive our portfolio forwards we are seeking a Senior Scientist Quality Control. This person will report to the Director Quality Control and, in collaboration with the senior CMC scientific team and Quality Assurance, will be responsible for management of QC analytical strategies, growing and developing the internal freeline QC regulated laboratory skill base with a focus on quality and GMP compliance, plus assisting with selection and management of external contracted partner laboratories. The successful candidate will play a key operational role in securing successful delivery of the Freeline CMC development programmes, building internal QC capability, and ensuring compliant release testing of GMP batches at both CMOs and the Catapult MC.

The successful candidate will join a rapidly growing world-class multidisciplinary team and will have the rare opportunity to not only to engage in laboratory science but also influence the shape and direction of this exciting new biotechnology venture.

Objectives:

Working with the Director Quality Control, Quality Assurance team and the Freeline laboratory operations teams:

  • Management of the Freeline Quality Control Laboratory (located alongside of Freeline’s GMP facilities in the Cell&Gene Therapy Catapult Manufacturing Centre Stevenage).
  • Support and manage identified/allocated outsourced programmes of work, providing scientific scrutiny and interpretation, ensuring compliant testing outcomes
  • Management of analytical methods transfer, development and validation at and between partner contract research organisations and insourcing to Freeline
  • Develop and maintain systems for specification approval, CofA issuance, stability testing and analytical trending.
  • Develop laboratory expertise in Freeline’s Quality Control laboratory best practice attainment of compliant systems, in preparation for GMP inspection and certification for QC testing

Basic Qualifications

  • Degree with experience in the Analytical Sciences relevant to Quality Control of Biotechnology/Biopharmaceuticals/Vaccines gained in the industrial field and of working within a Quality Management System
  • Current awareness and demonstrable experience in Good Manufacturing Practice Quality control testing regulatory compliance (MHRA GMP Guidelines, Eudralex vol. 4, QC Annexes)
  • Demonstrable knowledge of the documentation requirements for GMP Quality Control including maintenance of data integrity, computer systems validation, equipment procurement and qualification
  • Working within controlled document systems, the faithful reporting of data, generation of certificates, protocols, SOPs and written reports
  • Experience of working in pharmaceutical field with a regulated testing focus and of working in collaboration with Quality Assurance professionals, including supplier audits and in house auditing programs including environmental monitoring
  • Significant experience in Physicochemical, Biochemical, and Biological assays in a variety of applications
  • Detailed understanding of requirements of analytical methods validation and an awareness of all relevant guidance and regulations pertaining
  • Experience of working across multi-disciplinary, multi-cultural teams and with external partners
  • A working knowledge of Project Management, management of contracts.

Preferred Qualifications

  • Higher degree in a relevant discipline
  • A wide range of analytical techniques and expertise in analytical development
  • Experience of analytical process science, and/or formulation science for viral gene therapy products
  • Experience of early stage clinical development
  • Professional qualifications with independent recognition by learned societies

Current awareness

  • A good understanding of the biopharmaceutical development process and current awareness of developing trends in gene therapy regulatory requirements would be helpful.

To apply for this role email your CV and covering letter to recruitment@freelinetx.com

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Scientist – Vector Design

Job Location:

Stevenage, UK

Description:

Background information for the position  Freeline is a biopharmaceutical company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform developed by Amit Nathwani, Professor at UCL and CSO of Freeline Therapeutics. Freeline is fast progressing simultaneously several programmes towards clinical investigation and is now establishing a new Discovery Laboratories to ensure the rapid translation of our innovative vectors into clinic benefit. We have an existing opportunity for a creative scientist to be part of a truly innovative research in gene therapy to develop our next generation of therapeutics.

The position within the Research Department – We are seeking a highly motivated, enthusiastic and skilled individual with an excellent track record to contribute to the discovery of our next AAV-based gene-therapy medicines capable of changing the treatment paradigm. Scientist positions at Freeline are designed to provide a strong research foundation that is supported by our newly created state of the art facility based at Stevenage, UK. In addition to leading research within Freeline organization you will have the opportunities to establish collaborations with external groups.

The research group at Freeline places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. We will provide you with promising and exiting research projects in an environment that strongly values your development.

Candidate profile, role and requirement. – We are seeking individuals whose profiles will include:

  • A PhD-degree in a relevant biological discipline or equivalent level of professional qualifications with at least three years of post-doctoral experience
  • Strong knowledge in molecular biology, designing transgene cassettes, bioinformatics, gene therapy and previous experience in AAV vector is highly desirable. Ability to create and QC cDNA library is a plus.
  • Advanced experience in molecular biology techniques, including gene cloning, codon and promoter optimization, as well as experience in optimizing protein expression in mammalian cells.
  • Successful track record of scientific achievements through scientific publications and presentations.
  • Ability to think outside of the box and to provide creative solutions to challenging projects is a plus.
  • Excellent verbal and written communication skills are essential.

Please apply with your CV and covering letter to recruitment@freelinetx.com

Freeline offers a competitive industry salary and benefits package. For more information, please visit our website: http://www.freelinetx.com/

Closing Date:

25/05/2018

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