• Senior / Principal / Lead MSAT Scientist. Contract 6/12/2018 12:00:00 AM

    Salary: £0 Location: Oxford

    Senior/Principal /Technical Lead Scientist/Engineer (MSAT). Contract. Oxford My client, a globally renowned Gene Therapy are under going a phase of expansion. As part of this, they require support in Manufacturing Sciences and Technology team. There are currently 3 open positions for Contract MSAT Scientists/Engineers. Company and Team Overview An exceptional company with over 20 years’ experience in Gene and Cell therapy. True pioneers in the field, they were the first organisation to treat humans through in vivo lentiviral based vectors. This MSAT team is involved in all aspects of clinical and commercial manufacturing carried out either in-house or by third party CMO’s on behalf of the company. Job Overview ? Provide technical and scientific leadership to clinical and commercial manufacturing on-site and third party CMO sites including technology transfer, technical troubleshooting, complex deviation investigations, change control, and continuous improvement. ? Perform root cause investigations using a systematic approach to resolve complex problems and lead multidisciplinary teams in developing and implementing solutions. ? Gather, evaluate and analyse complex process data for all products and sites for manufacturing process robustness and capability via ongoing process verification. ? Partnering with other functions to ensure scale-up is robust and scientifically sound leading to consistent performance Key Responsibilities and Accountabilities ? The successful candidate will be an influential MSAT representative within the organisation working across multiple projects at different stages of the commercial lifecycle. ? Lead cross-functional activities working across Research, Process R&D, Manufacturing, Supply Chain and Quality Groups. ? Technical reviewer of manufacturing documentation (batch manufacturing records, deviation handling, CAPA, change controls, SOPs, etc.) ? Responsible for internal documentation to ensure quality and compliance required for regulatory submissions. ? Generate and review documentation supporting technology transfer and NPI. Define success criteria for technical transfer and provide expert evaluation of the technical outcomes. ? Help to build and maintain a process-specific knowledge database for technology transfer, NPI and process stewardship; identify continuous improvement activities to improve performance. ? Develop relationships with suppliers and service providers ? Provide guidance on process transfer and support activities to junior members of the team. Key Skills and Requirements ? Process development or GMP production experience preferred. ? Experience in aseptic processing and/or fill & finish would be an advantage. ? Proven influencing skills at all levels of the company across multiple project teams. ? As a person in plant, provide technical support and training of manufacturing personnel to improve understanding of cell culture, purification and fill & finish operations across the manufacturing sites. ? Expertise in the use / application of variety of problem solving tools and quality risk assessment methodologies would be ideal. *Travel may be required in support of tech transfer activities. Person Specification ? Minimum post-graduate degree in Biology/Biochemistry, Chemical/Biochemical Engineering or a related field with a minimum of 5+ years of industrial experience. ? Alternatively, a candidate with extensive industrial experience in Biologics (7 years+), ideally within a GMP regulated environment. ? Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners. ? Excellent communication skills to gain internal company support and influence external CMOs at all levels. ? Good time management and experience of dealing with conflicting priorities and multiple tasks. ? An interest in operational excellence is desirable. ? Knowledge of Microsoft Office Suite is required; preferably with data base development experience. ? Experience in process automation and software solutions would also be an advantage. The Package The successful candidates can expect a generous hourly rate and significant length of contract. In addition, this is an excellent opportunity to join a real player in the Gene Therapy sector and a chance to gain referrals, recommendations and build reputation.

  • Validation Manager 6/11/2018 12:00:00 AM

    Salary: £65000 Location: OXFORD

    Validation Manager (permanent)- Oxford- Biotech- up to £65k Based in Oxfordshire, my client is a world leader in Gene and Cell Therapy technologies. Due to a fantastic period of growth they have an exciting opportunity for a motivated individual to join and lead the validation department as a Validation Manager. You will be responsible for acting as the subject matter expert and supporting the GMP manufacturing facilities by managing and coordinating all aspects of validation (equipment & facilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) and overseeing the Validation Team. Key skills and requirements: You will have: BSc in life sciences or another relevant subject Significant validation experience within a GMP environment Valid UK Driving License Significant team management experience. Proven problem-solving skills/diagnosing faults/resolving qualification issues. Competitive Salary Fantastic development opportunities Great Career progression

  • Scientist (Bioinformatics – Genome Editing) 6/11/2018 12:00:00 AM

    Salary: £38000 Location: Oxford

    My client, a leader in synthetic biology, is a specialised contract research organisation offering services to support the discovery, development and production of biologics, with a particular focus on viral vectors for gene therapy applications. A unifying theme across the portfolio is expertise in DNA design, expression system optimisation, cell line development and engineering of viral delivery systems. They are located within purpose-fitted laboratories at the Oxford Science Park, just South of Oxford. They are in a phase of rapid expansion and are seeking highly motivated and enthusiastic scientists and engineers to join the team and help facilitate the next stage of their development as a company. My client seeks an enthusiastic and self-starting bioinformatician to design, implement and evaluate novel software tools to support their genome editing group. In particular, the successful applicant will train machine learning models to predict the targeting patterns of CRISPR/Cas9 gRNAs. The successful applicant will join their interdisciplinary bioinformatics team, working alongside scientific programmers, infrastructure engineers, and web app developers to support both commercial and R&D projects. No prior experience of working with CRISPR/Cas9 is needed. Key Responsibilities + Work with the genome editing team and NGS specialists to develop a framework for reliably evaluating the targeting patterns of CRISPR/Cas9 gRNA libraries. + Apply state-of-the-art data science and statistical learning techniques to derive gRNA suitability/fitness rule-sets from the in-house CRISPR/Cas9 NGS datasets. + Engineer user-friendly software tools to facilitate CRISPR/Cas9 gRNA library design against new targets; work closely with the in-house software engineers to integrate interfaces for these into the web-based LIMS. + Stay up-to-date with new developments, technologies and methods in genome editing, and proactively seek out collaborations with their group leaders to develop and extend our intellectual property portfolio in this area. + Carry out any other duties commensurate with the grading of this post, as required. Salary is negotiable on experience.

  • CMC Technical Specialist 6/11/2018 12:00:00 AM

    Salary: £60000 Location: Oxford

    CMC Technical Specialist – Oxford – Cell & Gene Therapy co. – up to £60,000 per annum The role is as an office-based technical specialist and author to provide Chemistry, Manufacturing and Controls (CMC) technical input into my client’s projects and external clients. The role includes overseeing CMC studies to ensure on-time delivery for project deadlines. In addition to liaising with my client’s staff across all operational departments, the successful applicant will also be required to build and maintain collaborative relationships with external organisations. + Collaborate with external partners to provide CMC technical support where my client’s technologies are employed. + To support and/or coordinate studies or activities for regulatory applications within defined project deadlines. + Support provision of high-quality documentation (e.g. technical protocols and reports) related to CMC sections of clinical trial applications and INDs, Marketing Authorisation Applications (MAAs) and Biological Licence Applications (BLAs). + Provide input for improvement of CMC technical development strategy, to keep it up-to-date with the evolving scientific and competitive environment. Key responsibilities: + Working closely with staff and project team members of client organisations to ensure delivery of CMC source documentation in support of regulatory submissions. + To author plans/protocols and reports and co-ordinate CMC-related studies e.g. Comparability protocols and reports. + To review CMC-related documents drafted by other departments to ensure that they meet regulatory and client expectations. To review CMC-related text incorporated into regulatory documentation to ensure accuracy and consistency with source documents. + To advise on the scope and impact of manufacturing and analytics planned changes and quality incidents. + To advise on analytical specifications to meet regulatory and client requirements, and to advise on corresponding acceptance limits. + To attend interdisciplinary project team meetings and provide updates on CMC-related activities. Key skills and requirements: + Educated to a minimum of Degree in a relevant scientific discipline, or equivalent qualifications and/or experience. + Knowledge of GMP-compliant manufacturing and/or analytics for biological medicinal product to support clinical development and commercial scale-up. + Previous experience of drafting high quality documentation such as technical reports. Desirable but not essential: + Knowledge of manufacturing and/or analytics for gene therapy vectors. + Experience of working within a CMC-focussed technical position (e.g. development, manufacturing and/or analytics) within the biopharmaceutical industry. The starting salary for this role ranges between £45,000 - £60,000 per annum, dependant on experience and qualifications.

  • Quality Associate 6/11/2018 12:00:00 AM

    Salary: £27000 Location: Oxford

    Based in Oxford my client are a leading research organisation offering services to support the discovery, development and production of biologics, with a particular focus on viral vectors for gene therapy applications. A unifying theme across the portfolio is expertise in DNA design, expression system optimisation, cell line development and engineering of viral delivery systems. They are located within purpose-fitted laboratories at the Oxford Science Park, just South of Oxford. They are currently looking for a Quality Associate with the following skills; + BSc in relevant discipline, with experience in a biological sciences laboratory environment + Experience working in a commercial / industry setting is preferred but not essential + Excellent working knowledge and skills in Microsoft Excel, Word and Outlook + High-level attention to detail, analytical and problem-solving skills + Previous experience working to ISO9001 and GLP quality standards + Previous experience in a quality assurance role. Salaries for the role are expected to be in the 20-28k range.

  • Senior Design Engineer 6/11/2018 12:00:00 AM

    Salary: £60000 Location: Oxford

    Based in Oxford the Senior Design Engineer will be part of a cross-functional team, responsible for the CAD, prototyping and early stage process engineering for the optical module of a 3rd party Augmented Reality application. This is a customer facing role and requires excellent communication and presentation skills. During the project, the Senior Design Engineer may lead sub-project teams focussed on resolving particular design challenges. They will be responsible for managing the design process for a number of components and sub-assemblies, from specification review and concepting to prototype release; including production and testing of prototypes and development of the prototype manufacturing process flow and Design for Manufacture (DfM) activities. The role therefore requires close and efficient coordination with the process team operating the product prototyping line and liaison with third party suppliers of materials, sub-components and equipment. Candidates should have the following skills; + Must be an experienced designer / engineer, possessing excellent written and oral communication skills (10+ years) + Team leadership skills + Working in a high-tech multidisciplinary environments; experience of customer-facing engineering consultancy an advantage + Experience managing suppliers + Working in accordance to ISO 13485, MDD and FDA 21 CFR regulations preferred but not essential. Salaries are expected to be in the 60k region.

  • Laboratory Manager 6/11/2018 12:00:00 AM

    Salary: £33000 Location: Warrington

    My client is an award-winning microbiology contract tester. The company specialise in tailoring anti-microbial assays as well as supporting clients through regulatory approval processes. The client has undergone recent expansion and is currently hiring an experienced microbiology laboratory manager. They will be responsible for the management and motivating of the current, dynamic, laboratory team as well as playing a pivotal role in the client’s future strategy by managing, planning and delivering projects to both current and prospective clients. My Client is looking for an experienced laboratory manager who has worked in a fast-paced microbiology environment. Experience in managing, planning and delivering multiple projects is essential to the role. The candidate must be well organised and be an effective communicator, with experience in managing and supporting a laboratory team previously. Salary: £28,000 - £33,000

  • Technical Leader 6/7/2018 12:00:00 AM

    Salary: £32000 Location: Bradford

    My client is a multinational business with laboratories throughout the UK focusing on pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical and chemical sectors. Due to expansion, there is an urgent need for a Technical Lead with experience in analytical sciences. + PhD in related Discipline + Small Molecule and Drug Development experience + Experience with Drug solubility If you are looking for a new position and would like to know more, please do get in touch.

  • Process Compliance Officer 6/6/2018 12:00:00 AM

    Salary: £40000 Location: OXFORD

    Process Compliance Officer Based in Oxfordshire, my client is a world leader in Gene and Cell Therapy technologies. Due to a fantastic period of growth they have an exciting opportunity for a motivated individual to join the manufacturing department in the role of Process Compliance Officer. As a Process Compliance Officer, you will work alongside the GMP Manufacturing teams to ensure the timely completion of batch related issues, as well as ensuring compliance with internal and external GMP requirements. Including leading investigations and root cause analysis into process and facility deviations, CAPAs and non-conformances with in a GMP, pharma/ Bio tech industry. You will have: Experience of working within a GMP manufacturing environment Experience with Manufacturing documentation such as SOPs, Deviations, Change Controls Risk Assessments and CAPAs Familiarity with Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity would be an advantage Competitive salary Excellent benefits

  • Quality Systems Officer 6/5/2018 12:00:00 AM

    Salary: £35000 Location: Oxford

    Our client is a leading biopharmaceuticals organisation based from state-of-the-art offices in Oxford. Having rapidly expanded over the course of the last 3 years to over 300 employees, they are currently recruiting a wide range of biotechnology based positions. The company are at the forefront of the gene and cell therapy sector, having built a novel drug development platform which they leverage to develop products both in-house and with partners. Their proprietary portfolio of products include a lead product for Parkinson’s disease. With preparations completed for this to move into the clinic, they are in active discussions with a number of third parties to potentially out-licence the product, thereby sharing the costs and the risks whilst retaining an interest in the value of the product as it progresses. Other products at development stage include a gene-based therapies for corneal graft rejection and cancer. The company have a very respected name in the industry, and offer potential candidates a strong career path, generous financial renumeration, and a caring yet focussed environment in which to flourish. We are helping them to recruit an experienced Quality Systems Officer for their quality department. Candidate should have the following skills and experience; + Minimum of 3 years working within a GMP pharmeuticals environment. + Solid working knowledge of validation and quality management systems. + Experience conducting quality based audits, investigations and root cause analysis. + Experience of document control and/or records management. + Strong team skills Salaries for the role are expected to be around the 35k mark.


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