We are looking to recruit an Analytical Development scientist to join our fast-growing ‘Product Development and Supply’ team based in either London or Edinburgh! This position is a full-time opportunity, on a permanent basis. In this role you will drive the development and implementation of new analytical approaches for the characterisation of genetically engineered macrophages for therapeutic applications in liver cirrhosis. You will work collaboratively with internal teams and multiple external partners to deliver programs of work which will help bring these much-needed therapies to patients.

Key responsibilities:

We are seeking an experienced and highly motivated scientist to play a key role in the execution of analytical development programs for the Resolution Therapeutics product pipeline.

Key responsibilities include:

• Play a key role in the delivery of analytical development activities including the design and authorship of experimental plans and the production of scientific reports
• Independently execute scientific programmes of work in the laboratory while following quality procedures
• Analysis of analytical data including interpretation of results and assessment of impact on project delivery
• Presentation and reporting of analytical development activities to the wider project teams
• Applying experience and creativity to overcome research challenges including assay troubleshooting to ensure analytical approaches are fit-for-purpose
• Designing and supporting activities for assay qualification both internally and in-collaboration with our external partner sites
• Production of technology transfer documentation
• Supporting training programs for external partners to support technology transfer
• Contribute to the continual improvement of processes for data analysis, recording and reporting.

Requirements for the role:

The successful candidate must have the following:

• An MSc or PhD in a field related to cell therapies
• A minimum of 2 years industrial experience applying a range of analytical assays, preferably relating to cell therapy characterisation
• A high level of experience in molecular biology and/or flow cytometry techniques
• Experience of using cell-based assays
• Experience of assay development and optimisation
• Experience of data analysis and the use of statistical programmes
• Experience of the processes involved in the qualification/validation of analytical assays
• Experience of working within a team environment to deliver results
• Experience of authoring and following SOP’s
• Ability to take initiative and work independently
• Ability to maintain accurate and up to date records

The following is also desirable:

• A working knowledge of immunology and chronic inflammatory diseases, preferably chronic liver disease
• Experience of the processes involved in technology transfer
• Experience of working with a quality management system
• Experience of working with different primary cell types including stem cells

Benefits:
Our competitive package includes discretionary bonus, income protection, pension, private health insurance, and life assurance, as well as an opportunity to participate in the Company’s incentive shares scheme.

Please direct any questions and CVs in the first instance to Harpreet Heir (harpreet@lifesciencepeople.co.uk) at Life Science People, our recruitment partners.

We are looking to recruit an Analytical Development Group Leader to join our fast-growing ‘Product Development and Supply’ team based in London! This position is a full-time opportunity, on a permanent basis.

In this role you will drive the development and implementation of new analytical approaches for the characterisation of genetically engineered macrophages for therapeutic applications in liver cirrhosis. You will work collaboratively with internal teams and multiple external partners to deliver programs of work which will help bring these much-needed therapies to patients.

Key responsibilities:

Scientific leadership

We are seeking an experienced and highly motivated scientist to lead the execution of analytical development programs for the Resolution Therapeutics product pipeline. This role will include line management responsibility for the London based analytical team and matrix management across a range of different company functions.

Key responsibilities include:

• Overseeing delivery of analytical development activities including approval of experimental plans and the sign-off of reports
• Review and approval of analytical data and the implementation of new methods for data modelling and trending
• Presentation and reporting of analytical development activities to senior management and wider project teams
• Supporting the development of analytical strategies to improve product and process characterisation and to drive advances in QC product release testing
• Providing management and direction to laboratory staff for project activities, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs.
• Resource management for the analytical team and prioritisation setting in-line with wider strategic objectives
• Playing a leading role in the continual improvement of processes for data analysis, recording and reporting.

Quantity & Regulatory support

Using your experience of cell therapy development and product characterisation you will contribute to the delivery of quality dossiers to support regulatory submission; this will include supporting:

• The compilation of Master Testing Strategies & QC profiles
• CMC & material risk assessments
• Identification and assessment of Critical Quality Attributes
• Compilation of dossiers for regulatory scientific advice

Technology transfer

The successful candidate will play a leading role in the transfer of products and processes to external partners to support GMP manufacturing. This will include:

• Designing and leading activities for assay qualification both internally and in-collaboration with our external partner sites
• Overseeing the production of technology transfer documentation in-line with quality principles
• Identifying and managing equipment purchases to allow assay transfer to QC
• Developing and managing training programs for external partners to support technology transfer
• Supporting the development of databases to record and analyse data from external partners

Requirements for the role:

The successful candidate must have the following:

• An MSc or PhD in a field related to cell therapies
• A minimum of 5 years industrial experience working in analytical development, preferably relating to cell therapy characterisation
• Proven experience in the development and qualification/validation of analytical assays
• Expert knowledge in molecular biology and/or flow cytometry techniques
• Experience of using cell-based assays for product characterisation
• Expert knowledge of analytical data analysis and the use of statistical programmes
• Experience of designing and implementing in-process control strategies to support cell therapy process development and/or GMP manufacturing
• Experience of working within a multidisciplinary team
• Experience of leading technology transfer activities to external sites
• An understanding of the regulatory and clinical processes involved during the cell therapy product lifecycle
• Experience of direct line management including goal setting and performing annual appraisals

The following is also desirable:

• Knowledge or experience in the application of different technologies used during cell therapy manufacturing
• Experience of activities and procedures required to manage a safe laboratory working environment
• Experience of working with a quality management system
• Experience of managing budgets and working to tight deadlines
• Experience or understanding of different primary cell types including stem cells

Benefits:

Our competitive package includes discretionary bonus, income protection, pension, private health insurance, and life assurance, as well as an opportunity to participate in the Company’s incentive shares scheme.

Please direct any questions and CVs in the first instance to Harpreet Heir (harpreet@lifesciencepeople.co.uk) at Life Science People, our recruitment partners.

We offer an exciting opportunity to join our fast-growing team as Director, Corporate Development. In this role you will participate in the company’s business development activities, including identification, negotiation and oversight of strategic partnerships.

Your responsibilities include:

• Identifying, scoping and proactively seeking partnerships and major supplier relationships for the company as needed to deliver the company’s strategy
• Leading negotiations and overall deal process around major partnerships, procurement arrangements
• Supporting the heads of R&D units on setting their respective strategy and long-term vision; overseeing strategic review exercises as required
• Contributing to the development of RTx’s Innovation Agenda by reviewing opportunity landscape, keeping up with new technology developments and working with the Head of IP on identify protectable areas for growth
• Overseeing and negotiating day-to-day legal contracts such as supplier agreements, confidential disclosure agreements, consultancy agreements and other operational agreements
• Responsible for analysing the global market of prospective companies to identify potential acquisition and partnership transactions in line with RTx’s strategic plan and innovation agenda
• Maintain industry-wide perspective on major trends and their implications for RTx. This includes competitive, technology, regulatory, distribution channel and macro-economic trends
• Track competitive landscape and carry out regular benchmarks to identify areas of opportunity
You will report directly to the VP, Corporate Development.
The successful candidate will have the right to work in the UK, and will have the following qualifications, skills, and experience:

Your Experience

Essential:

• An undergraduate degree, preferably up to at least Masters level in a scientific or engineering discipline
• 3-5 years’ experience at a top tier strategy consulting firm and/or in the biotechnology and pharmaceuticals industry
• Experience negotiating commercial partnerships and/or licensing agreements and/or major procurement deals; excellent negotiation skills
• Experience framing and modelling complex problems, making informed and reasonable assumptions and ultimately driving to a solution and recommendation
• Working knowledge of different types of commercial and legal agreements
• Excellent verbal, numerical and written communication skills
• Proficiency in preparing and presenting corporate documents for board-level audiences
• Self-starting, can-do attitude; comfort operating in a fast-paced uncertain environment
• Preferred – Experience working in a small company, preferably in the life sciences sector

Timing: Full time, from Q4 2022

Salary: Competitive

Incentives: An opportunity to participate in the Company’s incentive share scheme

Benefits: Competitive package including pension, private health insurance, life assurance, income protection and parental leave.

We offer an exciting opportunity to join our fast-growing team as a Research Scientist within our In Vivo Pharmacology unit. In this role, you will conduct in vivo experiments to assess the safety and efficacy of macrophage-based cellular products in relevant rodent-based models, with a view to understand the safety and efficacy of these products as may be relevant to humans.

Specific job responsibilities include:

• • Independently design and execute in vivo studies to test the safety and efficacy of macrophage cell therapy products in the RTx pipeline in relevant pre-clinical models
• • Appraising data to support the IVP unit in decision-making for the development of cell-based therapies towards clinical evaluation
• • Performing a suite of laboratory-based assays to measure parameters of fibrosis, injury, and inflammation in animal-derived tissue and biofluid specimens
• • Developing and executing assays and techniques to evaluate the pharmacodynamic effects of macrophage-based cell therapy products in relevant in vivo models
• • Appling experience and use creativity to overcome research challenges, including refinement of protocols to render assays fit-for-purpose, assay troubleshooting,
• • Quantifying and phenotyping of human and murine cell populations in tissues and biofluids (e.g. designing flow cytometry panels, qPCR arrays, etc.)
• • Establishing and maintaining a robust animal welfare environment to ensure compliance with the Animal (Scientific Procedures) Act 1986 as per Home Office regulations
• • Designing and executing pre-clinical studies in adherence to the principles of the 3 R’s (i.e. Replace, Reduce, Refine)
• • Interfacing with the other RTx research units, including Cell Engineering, Macrophage Biology, Induced Pluripotent Macrophages, and Translation units to streamline in vivo research activities
• • Independent writing of research plans, research reports, patents, and publications
• • Communication of data at regular Unit and Project research and strategy meetings

You will report directly to the Director of In Vivo Pharmacology,

You will collaborate closely with other scientists, associates, and technicians within the In Vivo Pharmacology unit who will support you in your role.

The successful candidate will have the right to work in the UK, and will have the following qualifications, skills, and experience:

Essential:

• • A PhD degree with relevant experience in a biological science (ideally pharmacology or immunology)
• • An active Home Office Personal Licence (PIL) or a PIL licence holder that has recently expired (i.e. within past 5 years)
• • 5+ years’ experience in conducting independent in vivo research using rodent disease models, ideally in liver disease (can include experience as a PhD candidate)
• • Experience of disease modelling under a moderate severity in accordance with Animal (Scientific Procedures) Act 1986
• • Experience of procedures pertaining to the administration of substances (e.g. injections via intraperitoneal, subcutaneous, or intravenous routes)
• • Excellent oral and written communication skills
• • Ability to maintain accurate and up-to-date records
• • Experience in standard laboratory techniques e.g., flow cytometry, qPCR, ELISA, histology, immunohistochemistry/immunofluorescence, microscopy
• • A working knowledge of liver immunology with relevance to chronic liver diseases

Preferred:

• • Industrial experience of drug development, ideally ATMPs, biologics, or cell and gene therapies
• • Experience with sterile primary cell culture, ideally with monocytes/macrophages
• • Experience of working with immunocompromised rodent strains
• • Knowledge of use of anaesthetics in pre-clinical species
• • Experience of online ordering systems (i.e., item procurement) and budgeting
• • An understanding of regulatory requirements for ATMPs
• • A working knowledge of pharmacology

Please direct any questions and CVs in the first instance to Harpreet Heir (harpreet@lifesciencepeople.co.uk) at Life Science People, our recruitment partners.

Timing: Full time, from Q4 2022

Salary: Competitive

Incentives: An opportunity to participate in the Company’s incentive share scheme

Benefits: Competitive package including pension, private health insurance, life assurance, income protection and parental leave.

We offer an exciting opportunity to join our fast-growing team as the Director of Pre-clinical Development, based in Edinburgh In this role, you will lead a team of in vivo scientists to assess the safety, efficacy and pharmacokinetics of macrophage-based cellular products in relevant pre-clinical models, with a view to understand the in vivo behaviour of these products as may be relevant to humans. Furthermore, you will manage R&D activities to fulfil regulatory requirements of the cell therapy product portfolio to enable their timely clinical evaluation. Specific responsibilities include:

• • Execute on the strategic direction of research projects in line with Company and unit objectives, including independently leading high quality scientific research and reporting on milestone delivery and project status at Senior Management meetings/Board meetings.
• • Develop and implement a pre-clinical strategy to satisfy the regulatory requirements of relevant agencies (e.g. MHRA/FDA) to enable progression of RTx’s cell therapy product portfolio towards clinical evaluation.
• • Manage and support relationships with internal and external partners, e.g. contract research organisation (CROs) to design and deliver datasets (including GLP studies) to satisfy any regulatory requirements.
• • Expand and develop RTx’s in-house pre-clinical platform to allow the prediction of in vivo behaviour of cell therapy products as may be relevant to human, including dose-response effects relating to safety, efficacy, and immunogenicity.
• • Direct line management of a team of in vivo scientists focused on development of unit technical expertise. Responsibilities include team recruitment, resourcing, people development, project prioritisation, and budgeting.
• • Resourcing and building a motivated and successful team capable of delivery high quality science and supporting each member’s personal and career development.
• • Support scientists in development of research projects and plans, interpreting experimental data, troubleshooting, identifying next steps, and effectively summarising data to stakeholders.
• • Identify and implement a translational framework to incorporate predictive in vivo models that can facilitate the clinical development of cell therapy candidates.
• • Maintain a focus on current and emerging techniques/technologies, whether threats or opportunities, and provide recommendations and action plans for applying these to research with a view to generate intellectual property.
• • Support the generation of external content including articles, manuscripts, webinars, conference presentations, etc.
• • Establishing and maintaining a robust ‘culture of care’ animal welfare environment to ensure compliance with the Animal (Scientific Procedures) Act 1986 as per Home Office regulations.
• • Collaborate with the IP team to generate strong data sets in support of patent filings.
• • Foster relationships with relevant stakeholders within and between unit functions to support and facilitate research and development.
• • Design and execute pre-clinical studies in adherence to the principles of the 3 R’s (i.e. Replace, Reduce, Refine).

You will report directly to the Chief Scientific Officer (CSO) – a search for a CSO is currently underway.
The successful candidate will have the right to work in the UK, and will have the following qualifications, skills, and experience:

Essential:

• • A PhD degree in a relevant biological science (e.g. cell biology, immunology, pharmacology)

• • Experience of progressing medicinal products (ideally ATMPs) towards clinical evaluation, including seeking and implementing advice from healthcare regulatory agencies (e.g. MHRA/FDA) to enable clincal trial authorisation
• • Experience of managing scientific projects with third-party vendors (e.g CROs) to provide GLP-accredited datasets as may be required for regulatory filings
• • A proven track record to delivering successful in vivo research projects with strategic input. Solution-focussed with excellent troubleshooting, problem solving skills
• • Extensive experience in managing a diverse team of scientists with demonstrable leadership qualities to empower and inspire a team
• • Effective communication skills to confidently convey relevant scientific and operational updates to key stakeholders, including the senior management team and board of directors on a frequent basis
• • Experience of disease modelling under a moderate severity in accordance with Animal (Scientific Procedures) Act 1986
• • Hands on experience in the field of organ fibrosis and inflammation, ideally in chronic liver disease (CLD)
• • 5+ years post-degree relevant laboratory experience
• • Strong publication and/or patent invention record demonstrating innovation
• • Understanding of intellectual property and the strategy needed to protect novel technologies/methodologies

• Based in the Edinburgh area or willing to re-locate

Preferred:

• • Industrial experience of drug development, ideally ATMPs, biologics, or cell and gene therapy
• • A fast learner who can effectively immerse themselves in new subject areas and apply this knowledge to drive and influence projects. Willingness to support scientists by performing laboratory experiments if required
• • Flexibility, adaptability, and ability to work in a fast-paced, matrix-managed environment
• • 3+ years line management experience
• • A previous procedure project licence (PPL) holder under the Animal (Scientific Procedures) Act 1986
• • A current personal (PIL) licence holder or a PIL that has expired within the last 5 years
• • A working knowledge of immunology
• • A working knowledge of molecular mechanisms of immunogenicity

For this vacancy, please direct any questions and CVs in the first instance to Harpreet Heir (harpreet@lifesciencepeople.co.uk) at Life Science People, our recruitment partners

• Job Type: Full time
• Start Date: ASAP
• Benefits: Our competitive package includes income protection, pension, private health insurance, and life assurance, as well as an opportunity to participate in the Company’s incentive shares scheme.

We are looking for an experienced Research Associate to join the fast-growing team within our iPSC Biology unit at our site in Edinburgh! This position is a full-time opportunity, on a permanent basis.

In this role, you will carry out scientific discovery work relating to iPSC-derived macrophages for therapeutic use in liver cirrhosis. You will report directly to the Group Leader, iPSC Biology and will collaborate closely with a Research Scientist within the same Induced Pluripotent Stem Cell unit.

• Key Responsibilities:

• • iPSC culture and characterisation
• • Develop and optimise protocols for macrophage differentiation
• • Supporting the engineering of iPSCs and derived macrophages g., for hypo-immunogenicity, as well as introduction of phenotype enhancing payloads
• • Supporting the scale-up efforts using multiple culturing formats
• • Interfacing with the Cell Engineering, In Vivo Pharmacology, Translational and Macrophage Biology units to identify best-in-class iMACs products and collaborate on assay development, scale-up and in vivo studies
• • Assisting with writing patents, publications and summarising data for progress reports and presentations
• General laboratory management and instrument maintenance duties

• • • • Please note that this list is not exhaustive
        

      • Your Qualifications and Experience

        Essential

        • • A bachelor’s degree in Biology, Biochemistry, or a related discipline
          • • Proven track record with at least 3 years’ experience working in an academic or industrial setting
        • • Experience with stem cells, including their characterisation and differentiation into desired target cell
          • • Experience with cell-based assays using flow cytometry and magnetic bead separation (MACS or similar)
          • • Experience with primary immune cell culture, preferably monocytes/macrophages
          • • Experience in molecular biology techniques such as nucleic acid extraction and purification, PCR and qPCR
          • • Experience in western blotting, ELISA, immunofluorescence, and immunohistochemistry
          • • Ability to maintain accurate and up to date records, as proven by a track record of publications as co-author

        Preferable

        1. • Experience working with iPSCs and differentiation
        2. • Knowledge of cell engineering techniques
        3. • A working knowledge of inflammation and chronic liver disease
        4. • Experience with cloning and transfection
        5. • Familiarity with the principles of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) and writing of standard operating procedures

         

      • Selection Process:
        1. Following your application, an initial call will be scheduled by the Recruitment Partner before being shortlisted. If successful, you will be invited to start the interview process which consists of 3 stages:
           1. 1. 1. Initial meeting with the Hiring Manager and another member of the RTx team
              2. 2. Presentation & panel interview
              3. 3. Conversation with the CEO

           Please be aware that due to the volume of applications, feedback will not be provided at the application stage.

           For this vacancy, please direct any questions and CVs in the first instance to our Recruitment Partner at Life Science People, Harpreet Heir harpreet@lifesciencepeople.co.uk.

           • • Alternatively, apply through the link below.