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

QA Specialist

Job Location:

Stevenage, UK

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.

Role and Responsibilities:

  • Review and progress Change Controls, Deviations, OOS reports and CAPAs
  • Review and approve Standard Operating Procedures
  • Issuing batch manufacturing records and labels to Production
  • Release raw materials for use in manufacturing
  • Review of validation protocols and reports
  • Coordinate batch manufacturing reviews
  • Maintain Product Specification File (PSF)
  • Manage Quality/ Technical Agreements with third parties
  • Review and approve controlled-temperature shipment data
  • Conducts internal audits to monitor procedural compliance
  • Trend quality metrics

Qualification, Education and Experience Required:

  • Educated to degree level or equivalent in a biological or physical science
  • Prior relevant experience in a Quality Assurance role in the Pharmaceutical/Biotech industry, of which a minimum of two years in a GMP-regulated environment, ideally working with Investigational Medical Products (IMPs)
  • 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)

Preferred Skills:

  • Experience working with biologics, preferably ATMPs
  • Experience working with investigational medicinal products (IMPs)
  • GCP QA experience
  • Excellent interpersonal skills
  • Excellent verbal and written communication and computer literacy skills
  • Effective time management

Additional Skills;

  • Proficient with Microsoft Excel and PowerPoint
  • Familiarisation with electronic documentation systems

Closing Date:

30th November 2018

Job Reference Code:

QAS

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Clinical Supply Chain Manager

Job Location:

Stevenage, UK

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.

As part of building our team to support our growing clinical portfolio we are seeking a Clinical Supply Chain Manager. This person will report to the Director Drug Product Delivery and will be responsible for ensuring timely delivery of packed and labelled clinical product from partner CMOs.

The successful candidate will provide a key interface between CMC and clinical and will play a pivotal role in developing internal processes for forecasting and managing clinical supplies.

This is an exciting opportunity to join a rapidly growing world-class multidisciplinary team in developing life changing gene therapy medicinal products.

Role and Responsibilities:

  • Work closely with clinical operations to define product supply requirements for clinical studies for all Freeline projects.  Act as the clinical interface within the CMC teams and ensure that drug product manufacturing is scheduled appropriately to deliver the required clinical supplies
  • Oversee the day to day management of clinical packaging, labelling and supply activities including developing plans, managing budgets and liaising with CROs
  • Take the lead in identifying, evaluating and selecting clinical packaging and labelling CROs for future studies
  • Draft suitable label text for clinical drug product, ensuring annex 13 compliance
  • Facilitate interactions between the QPs responsible for final certification of packed product and the CMC manufacturing teams to ensure a smooth batch certification process
  • Ensure that product shelf lives are updated in a timely manner to ensure ongoing availability of clinical supplies
  • Work with clinical to develop robust IMP management plans, including procedures for performing dose calculations and preparing infusion solutions
  • Provide support to clinical sites in establishing procedures for preparing infusion solutions
  • Work with CMC development to ensure suitable ‘in use’ studies are performed to support clinical administration procedures
  • Work with the external supply function to develop appropriate procedures for packaging and shipping IMP from manufacturing CMOs to pack/label CMOs
  • Draft IMP content for clinical documents, such as protocols
  • Ensure trial master file is updated with appropriate IMP documentation
  • Write SOPs as appropriate to define the clinical supply chain processes

Qualifications & Experience Required:

  • Scientific background and educated to at least degree level. A pharmacy background is desirable but not essential
  • At least 3-5 years previous experience of clinical supply chain management
  • Experience of selecting and managing clinical packaging and labelling CMOs
  • Understanding of labelling and packaging requirements for IMPs
  • Experience of working in cross-functional teams and acting as the CMC-clinical interface preferably in a biopharmaceutical environment
  • Experience of managing clinical supplies for infusion studies (preferable but not essential)

Skills Required:

  • Excellent interpersonal, communication and facilitation skills
  • Ability to work autonomously and within a multi-disciplinary and cross-site team environment
  • Ability to manage and track budgets
  • Ability to effectively manage external partners
  • Excellent verbal and written communication and computer literacy skills
  • Effective time management
  • Ability to travel to work partners in Europe or further afield as the role requires

Closing Date:

30th November 2018

Job Reference Code:

CSM1

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Scientist/Senior Scientist – Biochemistry, Protein Production & Characterisation

Job Location:

S

Description:

Freeline, a privately-held gene therapy company, has a vision to create better lives for people suffering from chronic systemic diseases using the potential of gene therapy as a one-off curative treatment. We recently opened our state-of-the-art laboratory at the Stevenage Biosciences Catalyst, a short 20-minute train north of London. Our recent series B funding round of £88M has enabled the recruitment of the brightest Scientists, who drive their projects using the best available or novel cutting-edge technologies.

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 who will lead Protein Production and Characterisation efforts across the entire Research Department, which encompasses all pre-clinical pipeline programs. The Scientist will express, purify and characterise proteins relevant to Freeline research activities. The Scientist will have unlimited opportunities to collaborate with multi-disciplinary teams 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 Protein production and purification efforts in research
  • Lead stable cell line development for the expression of recombinant proteins
  • Planning and hands-on throughput of biochemical/biophysical 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 assay development, 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 purifying tagged and non-tagged proteins from cell culture is essential; purification from complex biological material such as plasma or tissues is strongly preferred
  • Experience in mammalian cell culture and protein production is essential
  • Experience with AKTA purification systems and Unicorn software is strongly preferred
  • Experience in enzymology of proteases (e.g. Ki, Kd, Km determination), especially serine proteases is strongly preferred
  • Experience culturing insect cells and/or bacteria for protein production would be an asset
  • Experience with Biacore/SPR and/or other biophysical techniques would be a plus
  • Highly collaborative Scientist with excellent communication and inter-personal skills
  • Demonstrated ability to independently analyse, interpret and present data in a clear manner
  • 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
  • Flexible worker who is willing to put their own projects on hold to advance other urgent projects to meet demanding timelines

Closing Date:

30th November 2018

Job Reference Code:

Scientist1

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Quality Control & Bioanalytical Senior Scientist

Job Location:

Stevenage, UK

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.

As part of building capability to drive our portfolio forwards,  you will join a rapidly growing world-class multidisciplinary team and not only to engage in laboratory science but also influence the shape and direction of this exciting new biotechnology venture. A key operational role in securing successful delivery of the QC service underpinning internalised Freeline GMP manufacturing capability at Catapult and regulated  bioanalytical testing for preclinical and clinical programmes.

Reporting to the Director Quality Control as part of the Quality Control team,  in collaboration with the GMP operations,  Quality Assurance, CMC-Development, Clinical Operations, Research teams, you will take responsibility for management of external contracted partner laboratories and QC input into Project teams.

Objectives: 

  • Support and management of defined outsourced programmes of work, providing scientific scrutiny and interpretation, ensuring compliant and valid testing outcomes spanning GMP and GCP providers
  • Drive analytical methods transfer, development and validation at and between partner contract research organisations including in vivo and in vitro applications
  • Develop the overall QC strategy for specific Projects/Programmes (from before first-time-in-human through to commercial phase)
  • Contribute to the development of the Freeline QC Procedures and policies
  • Lead the analytical sub-team of clinical-phase projects to coordinate and drive delivery of all analytical tasks
  • Drive specification approval, CofA issuance, stability testing and analytical trending and QC oversight of Projects/Programmes
  • Champion best practice laboratory expertise with our testing partners and share best practice with other QC managers
  • Provide expert practical input enabling establishment of the Freeline Quality Control and Regulated Testing Laboratories, located at the Stevenage site.

Qualifications Required

  • Degree with experience in the Analytical Sciences relevant to development of Biotechnology/Biopharmaceuticals/Vaccines gained in industry and/or research
  • Significant experience in Physicochemical, Biochemical, and Biological assays in a variety of applications. Practical experience of range of analytical methodology including:
    • Molecular biology techniques
    • Immunoassay techniques
    • Proteomics
    • Methods for quantitation of large or small molecules
    • Cell culture and microscopy

Combined with in specialised in depth expert knowledge in one or more technique.

  • Current awareness and demonstrable experience in GMP Quality control and GLP/GCLP testing regulatory compliance (MHRA GMP Guidelines, Eudralex vol. 4, QC Annexes; ICH Quality topics; EU and US Bioanalytical Method validation)
  • Detailed understanding of requirements of analytical methods validation and an awareness of all relevant pertaining guidance and regulations
  • Demonstrable knowledge of the documentation requirements for GXP Quality Control and bioanalysis 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 within a QMS and of working in collaboration with Quality Assurance professionals, including auditing programs
  • Experience of working across multi-disciplinary, multi-cultural teams and with external partners
  • A working knowledge of Project Management including management of contracts
  • An understanding of the biopharmaceutical development process

Preferred Qualifications

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

 

Closing Date:

30th November 2018

Job Reference Code:

QC2

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Quality Control Scientist

Job Location:

Stevenage, UK

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.

As part of building capability to drive our portfolio forwards,  you will join a rapidly growing world-class multidisciplinary team and to engage in laboratory science at this exciting new biotechnology venture. This is a key laboratory-based, hands-on operational role ensuring delivery of the QC service, critical to corporate strategies.  The internalised QC laboratory supports the Freeline GMP manufacturing capability  and regulated  bioanalytical testing for Freeline preclinical and clinical programmes.

Reporting to the Quality Control Manager, the main duties are as follows:

  • Execution of analytical testing programmes as directed by the QC Manager, according to GXP, with defined schedules and responsibilities
  • Following SOPs and Protocols, effective performance of analytical methods generating valid and reliable data
  • Generation of QC and bioanalytical data for the following:
    • Raw material release
    • Batch release
    • Stability studies
    • Clinical testing
  • Accurate and compliant data recording and reporting of all data, per SOPs, including peer review checking
  • Effective team working within QC and across company departments where required
  • Routine maintenance, verification and qualification of specified analytical systems
  • Interaction with quality professionals and responding to audit findings as required by the QC Manager
  • Presentation of data at Project Team meetings
  • Participation in analytical investigations when required, within a culture of continuous improvement, and notification of unusual observations, errors/unexpected findings to management
  • Contribution to analytical methods development
  • Participation in training and development programs as required
  • Compliance with Health and Safety legislation and company policies,  identification of potential hazards in the workplace

Qualifications Required:

  • Degree with experience in the Analytical Sciences gained during development of Biotechnology/Biopharmaceuticals/Vaccines either in industry and/or research
  • Significant experience in Physicochemical, Biochemical, and Biological assays in a variety of applications, including two or more of:
    • Molecular biology techniques
    • Immunoassay techniques
    • Proteomics
    • Methods for quantitation of large or small molecules
    • Cell culture and microscopy
  • Knowledge of analytical methods validation and an awareness of guidance and regulations
  • Contribution to reporting of data, generation of certificates, protocols, SOPs and internal written reports
  • Experience of working within a QMS
  • Good communication skills and the ability to present and explain data (internally and externally)
  • A flexible approach plus the ability to work to set priorities and deliver projects on time in a fast moving agile work environment
  • Self-motivated individual with the ability to work with multi-disciplinary, multi-cultural teams achieving a high standard of work

Preferred Qualifications/Experience

  • Experience of analytical testing in a regulated environment
  • Experience of GxP documentation requirements for Quality Control and bioanalysis, with an emphasis on data integrity and ensuring confidentiality at all times
  • Higher degree in a relevant discipline
  • Expertise in analytical development
  • Experience of analytical process science, and/or formulation science for viral gene therapy products
  • Experience of pre-clinical and early stage clinical development
  • Professional qualifications with independent recognition by learned societies

 

Closing Date:

30th November 2018

Job Reference Code:

QC1

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Supply Chain Co-ordinator

Job Location:

Stevenage, UKFreeline 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.

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.

Role and Responsibilities:

  • Execute planning processes to ensure delivery of materials required for GMP batch manufacture as required by the schedule.
  • Be the first point of contact for inbound related queries for materials needed in the Freeline GMP facility.
  • Daily administrative duties, including checking delivery documents, booking materials in.
  • Act as the interface between suppliers, Freeline 3rd party warehousing, Freeline material receiving warehouse and manufacturing teams.
  • Complete routine stock checks and Control stock at optimum levels throughout the supply chain to achieve stock holding targets.
  • Assist in the design, implementation of Stock control procedures.
  • Implement SOPs and other documentation to support and control Freeline supply chain and inventory activities as required.
  • Support supply chain deviations, investigations, incidents and CAPAs as required.
  • To liaise confidently with Freeline team members, collaborators and vendors to ensure requirements for manufacture are met.
  • Become fully trained in all Freeline procedures as required.
  • Support the development and implementation of inventory management systems.

Experience Required:

  • Practical experience and a sound understanding of the required industry standards for supply and distribution of materials for GMP manufacture and clinical supply.
  • Strong IT and planning skills.
  • Experience in one or more of the following areas would be beneficial:
    • Logistics and Custom regulation exposure.
    • Experience of working in a highly regulated industry; Pharmaceuticals or Biotechnology

Preferred Skills:

  • ERP system experience with working knowledge of purchasing and inventory modules would be advantageous. (Sage, SAP, Oracle)
  • Strong MS Excel and analytical skills

Closing Date:

12 November 2018

Job Reference Code:

SUPP1

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IT Manager

Job Location:

Stevenage, UK

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 IT Manager will deliver an agreed portfolio of IT projects across all functional areas. This is a strategic yet hands on role requiring someone who can work independently and who can balance priorities and deliver pragmatic solutions quickly.

Responsibilities:

Design and deliver IT solutions to meet the needs of a rapidly growing organization:

  • Gather and evaluate business needs by gathering information, evaluating needs, anticipating requirements and uncovering areas for improvement including designing a full IT system roadmap
  • Evaluate system and software solutions and communicate practical system recommendations including cost estimates
  • Document and design new processes/ workflows and communicate clearly difficult concepts to non-technical internal users
  • Translating business requirements into functional requirements and writing specifications documents
  • Working with IT/Finance & Procurement in the organisation to provide technical input to conduct formal RFP procurement processes and provide technical evaluation of responses to successfully procure systems and software
  • Work independently and collaborate with functional colleagues to deliver IT projects on time and within budget
  • Conduct system testing and validation to sign off systems prior to go live
  • Trouble shoot and provide ad hoc support to investigate ongoing or one-time operational issues and determine solutions and creative work arounds
  • Staying up-to-date with IT advancements to automate and modernise systems
  • Oversee Capex and infrastructure purchasing
  • Working with our outsourced IT providers in the UK and overseas
  • Provide staff training on our key systems and inductions for new starters on key software

Qualifications, Experience & Skills:

  • A bachelor’s degree preferably in IT or computer Science or alternatively relevant IT experience
  • Minimum of 5 years’ experience working in IT related project management with operational experience or experience in a very closely related field
  • Technical experience in testing and validation of systems
  • Experience of developing and delivering on an IT roadmap
  • Competency in Microsoft applications including Word, Excel, and PowerPoint
  • Life sciences industry experience is an advantage but not essential
  • Excellent spoken and written communication skills with great attention to detail for developing documentation
  • Strong time management skills, self-motivated, solution orientated and able to organise own workload
  • Good interpersonal skills and relationship builder with the ability to influence internal and external stakeholders
  • Creative and inquisitive with good analytical, critical thinking and problem-solving skills

Closing Date:

31st October 2018

Job Reference Code:

IT1

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GMP Biotechnologist

Job Location:

Stevenage, UK

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.

Responsibilities:

  • Be part of the GMP manufacturing operations team responsible for delivering GMP manufacturing batches for clinical studies.
  • Become fully trained in all areas of the manufacturing process as required.
  • Write and review SOPs, batch records, protocols, reports etc. to support GMP manufacture.
  • Ability to identify issues as they occur and report accordingly with all relevant information.
  • To support investigations, OOS, incidents and CAPAs as required.
  • To be part of the team responsible for technology transfer of the process into GMP according to the approved protocols.
  • To work closely with facility and other supporting teams to ensure requirements for manufacture are met.
  • General duties involved in the maintenance of clean room production facilities to GMP standards.
  • General duties involved in the preparation of equipment, materials and facilities ready for GMP manufacture.

Education:

Degree in Biological Sciences

Experience Required:

  • At least 2 years of hands-on, practical experience in biological drug substance GMP manufacturing operations.
  • A sound understanding of the required industry standards for GMP manufacturing of investigational medicinal products.
  • Hands on experience in aseptic cell culture processing for seed train expansion prior to USP.
  • Hands on experience in the upstream and/or downstream processing for viral vector manufacturing.
  • Experience in one or more of the following areas would be beneficial:
    • Facility operations
    • Equipment qualification and validation.
    • Technology transfer.
    • Process validation.
  • Experience and technical understanding of AAV or other viral vector development/manufacture would be advantageous
  • Experience of GMP facility set up preferable

Closing Date:

31st October 2018

Job Reference Code:

GMPB1

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QA Manager

Job Location:

Stevenage - SBC

Description:

Role and Responsibilities:
  •  Assist QA Director with QMS design and implementation project
  • 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
 Qualification, Education and Experience Requirements
  • Educated to degree level or equivalent in a biological or physical science
  • Experience in Quality Assurance in the pharmaceutical/biotec industry, minimum 6 years GMP experience with minimum 2 years in biologics.
  • Demonstrates working knowledge of biologics and/ or ATMPs and IMP manufacturing
  • 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 Outlook, Word, Excel and Powerpoint)
  • 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
Preferred Skills
  • GCP experience
  • Qualified Person (QP) status would be an advantage but not essential
  • Experience implementing electronic document management systems

Job Reference Code:

17092018

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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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GERMAN VACANCIES

Lab Manager / Compliance Manager (m/w) – Teilzeit (20h/Woche)

Job Location:

Munich, Germany

Description:

Freeline Therapeutics ist ein privates Biotechnologie-Unternehmen mit Sitz in Großbritannien und Deutschland. Unsere Vision ist es, Menschen mit chronischen Erkrankungen ein besseres Leben zu ermöglichen, indem wir das Potenzial der Gentherapie zur Heilung von Patienten mit einer nur einmal benötigten Medikation nutzen. Dabei hat sich Freeline auf die AAV-basierte Gentherapie in der Leber fokussiert mit dem Ziel, Therapien für Krankheiten mit bisher nur sehr eingeschränkten Behandlungsmethoden anbieten zu können.

Unser spezieller Gentherapie Ansatz baut dabei auf der Pionierarbeit von Professor Dr. Amit Nathwani (Professor für Hämatologie am University College London und CSO bei Freeline Ltd) auf, die bereits das Leben von Hämophilie B Patienten durch eine sichere, effektive und zuverlässige Gentherapie verändern konnte.

Darauf aufbauend wurde ein firmeneigenes AAV-Kapsid entwickelt, welches einen noch effizienteren Gentransfer in die Leber und somit die dauerhafte Expression eines gewünschten Proteins in großen Mengen ermöglicht.  Die Funktionalität dieses optimierten AAV Kapsids wird aktuell an weiteren Hämophilie B Patienten in einer zweiten klinischen Studie validiert, deren bisherige Ergebnisse die Eignung dieses Therapieansatzes für eine angestrebte Heilung der Patienten nach einmaliger Behandlung bestätigen. Weitere Indikationen befinden sich bereits in der Vorbereitung zur Klinik.

Eine kürzlich durchgeführte Finanzierungsrunde der Serie B in Höhe von 88 Mio. GBP ermöglicht uns nun die weitere Rekrutierung von außergewöhnlichen Talenten, die gemeinsam mit uns an der Anwendung und Weiterentwicklung unserer AAV-basierten Gentherapie Plattform arbeiten.

Zur Verstärkung unseres Standortes in München suchen wir in Teilzeit (20h/Woche) zum 01. Januar 2019 eine/einen:

Lab Manager / Compliance Manager (m/w) – Teilzeit (20h/Woche)

 

Ihre Aufgaben sind:

 

Sie sind für die Aufrechterhaltung der hohen Qualitätsstandards an unserem Standort verantwortlich. Hierbei zählen vor allem die Kontrolle und Weiterentwicklung unseres bisherigen Qualitätsmanagement Systems im Bereich Labor, Dokumentation, Arbeitsanweisungen, Wareneingang- und Beschaffung sowie Geräteinstandhaltung zu Ihren Hauptaufgaben. Sie sind für die Schulungen neuer Mitarbeiter zuständig und koordinieren den Ablauf etablierter Prozesse. In enger Zusammenarbeit mit dem Bereich Lab Support berichten Sie an den Teamleiter Assayentwicklung.

Bevorzugt wäre eine gleichmäßige Verteilung der 20h/Woche auf mindestens 4 Tage die Woche.

Ihre Qualifikationen:

 

  • Sie haben ein abgeschlossenes Studium (Bachelor, Master oder Diplom) der Biologie, Biotechnologie oder Biochemie oder eine vergleichbare Ausbildung mit biologischem Hintergrund und somit ein Grundverständnis für biologische Zusammenhänge.
  • Aufgrund Ihres bisherigen Werdegangs haben Sie bereits erste Erfahrungen im industriellen Umfeld sammeln können und verstehen die Ansprüche an die hohen Qualitätsrichtlinien im Bereich Dokumentation und Datenmanagement in einem GxP Labor.
  • Sie sind geübt im Erstellen von Arbeitsanweisungen, Berichten und Präsentationen in deutscher und englischer Sprache und haben bereits erste Erfahrungen in der GxP gerechten Dokumentation.
  • Die Anwendung von Microsoft Office Tools zur professionellen Dokumentenerstellung sind für Sie selbstverständlich.
  • Es macht Ihnen Spaß Prozesse zu optimieren und Sie zeichnen sich durch eine strukturierte und organisierte Arbeitsweise aus. Komplexe Zusammenhänge erfassen Sie schnell und können diese geordnet und verständlich Anderen näherbringen.
  • Sie sind eine kommunikative Person, für die Frontalschulungen von Kollegen in deutscher und/oder englischer Sprache kein Problem darstellen. Regelmäßige Interaktion mit Kollegen bereitet Ihnen Freude.
  • Sie arbeiten äußerst präzise und besitzen eine hohe Teamfähigkeit sowie ein ausgeprägtes Verantwortungsbewusstsein.
  • Vorkenntnisse im Bereich der Virologie speziell mit AAV und mit Arbeiten unter biologischer Sicherheitsstufe 2 sind keine Voraussetzung.
  • EDV-Kenntnisse (v.a. MS-Office) und sehr gute Kenntnisse der englischen Sprache (in Wort und Schrift) werden benötigt.

 

Wir bieten Ihnen eine unbefristete Stelle in einem jungen Biotech-Unternehmen im Südwesten Münchens. Sie erwartet ein attraktiver Arbeitsplatz mit vielseitigen und abwechslungsreichen Tätigkeiten in einem innovativen Unternehmensumfeld.

Wenn wir Ihr Interesse geweckt haben, dann senden Sie uns bitte Ihre vollständigen Bewerbungsunterlagen mit Angabe des möglichen Eintrittstermins und Ihrer Gehaltsvorstellung mit Bezug auf den Referenz-Code „LABM“ per Email an: infode@freelinetx.com

Freeline Therapeutics GmbH

Semmelweisstraße 3

82152 Planegg

Closing Date:

30th November 2018

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