Jobs

We found 300 job(s) for you:

  • QMS and Compliance Lead

    Salary: £0 Location: SALISBURY

    Focused on curing the worlds deadliest diseases, this pioneering biopharma is now seeking a QMS and Compliance Lead to join their team on a fixed term basis. Acting as QMS and Compliance Lead will see you at the helm of a Cross Disciplined team, delivering compliant Quality Systems and developing an industry leading QMS. Other duties include: • To keep up to date with the requirements of the Medicines Authorities across the EU and rest of world (where relevant) • Provide oversight and direction to development and GCP teams to enable new products to be brought to market. • To provide input and leadership with the Quality Management System (QMS) within the business to drive simple compliant systems. • Assistance with regulatory inspections and client audits. • To promote and uphold the highest standards of professionalism in order to create, maintain and enhance the reputation of the business, amongst its customers and stakeholders both nationally and internationally • To review company Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and company procedures. • To deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness • To liaise and interact positively with appropriate regulatory authorities to ensure company compliance This is a fantastic opportunity and an opportunity to join a team where you can be proud to be producing life-saving products that really make a difference. The company boasts flexible working hours, innovative projects and an incomparably intelligent team to work alongside.

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  • Regulatory Affairs Officer

    Salary: £35000 Location: Borehamwood

    Based in Hertfordshire, my client manufactures a wide range of plasma-derived therapeutic products which are distributed to over 40 countries worldwide. They are committed to supporting both healthcare professionals and providing a continuous supply of reliable, high quality, life saving products to patients on a 24/7, 365 day a year basis, and have a vibrant 60-year heritage and is currently embarking on an ambitious programme of investment in research, technology and manufacturing methods to grow the business significantly over the next few years. They are currently recruiting for a number of positions and are interested specfically in receiving applications from qualified regulatory affairs officers with the following skills; + Min of 3 years experience in a Regulatory Affairs function + Solid experience with licencing activities in Middle East countries, South America and Asia. + Knowledge of generation and maintenance of Company Core Safety Information (CCSI) + Experience with the end-to-end procedure for generation of drug labels and maintaining compliant drug labels in the UK and 'rest of world markets' + Experience of dealing directly with Health Authority assessors, in particular the MHRA. + Demonstrated effective communication and collaboration with agents and distributors in 'rest of the world 'countries. + Knowledge of current legislation and guidance related to labelling of medicinal products. + Knowledge or experience of generating eCTD documentation packages, in particular Module 1 Salaries are dependent on experience.

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  • Product Manager

    Salary: £50000 Location: Wokingham

    Based in Wokingham my client designs and delivers labelling solutions for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labelling regulations and audits, they empower their clients to safeguard their reputation by ensuring compliance, and significantly reduce costs by eliminating recalls through labelling errors. They are the market leader in world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients in varied sectors including medical device, life sciences, healthcare, automotive, chemical and manufacturing. Based in the global headquarters, the product management function is responsible for managing the end-to-end lifecycle of the product portfolio. The Product Manager will take responsibility for understanding specific market sectors, industry drivers or opportunities, and for developing strategies to address these effectively. These will usually comprise the development of new or existing software products and propositions. The Product Manager will be responsible for ensuring market and customer requirements are captured and documented accurately, and for conveying the prioritised requirements effectively to the Development team. They will lead virtual teams in the design, costing, development and market launch of these software products, being responsible for bringing these to market on time and budget. Salary is negotiable on experience.

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  • Scientist – Lentiviral vectors

    Salary: £38000 Location: Oxford

    My client are 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. We 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 our development as a company. The Scientist – Lentiviral Vectors will be involved in a range of internal platform development and commercial projects, predominantly focused on Lentiviral vector engineering, and establishing stable viral packaging cell lines and associated processes. They have a number of on-going programmes and collaborations in this area, and multiple government supported grant awards, which the recipient will contribute towards. Scientist colleagues are expected to drive and lead specific projects and areas of research from the bench, while providing support and training to technicians working in the group. The position will involve extensive interaction with both internal and external stakeholders, and the ability to show commitment to scientific development and innovation are considered essential. Candidates should have; + PhD/DPhil in relevant discipline, or MSc with significant experience (>4 years) + Experience working in a commercial/industry environment is preferred but not essential + Extensive track record of handling a range of adherent and suspension mammalian cell lines + Knowledge and experience of viral vector engineering, production and characterisation, with a focus on Lentivirus + Good experience with analytical techniques including flow cytometry and qPCR Salaries are expected to be around the 28-38k mark.

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  • Scientist- AAV Production

    Salary: £38000 Location: Oxford

    Based in Oxford my client who are 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. We are located within purpose-fitted laboratories at the Oxford Science Park, just South of Oxford. They are currently looking for a scientist in their AAV Production team who will manage an internal function for the generation and characterisation of AAV vectors for both in-vitro and in-vivo applications (non-GMP). The appointee would work to expand this service within the company and would then be responsible for its operational delivery working with technician colleagues. This function would sit within the AAV Vector Group, which addresses both viral vector engineering and novel-bioproduction methodologies and works with a number of academic and industry collaborators. Candidate should have the following skills; + Prior experience in generating and characterising AAV vectors is essential. + Relevant techniques (see next section) include plasmid preparation, transfection (hyperflask/stack, cell factories, suspension), harvest/clarification, purification by iodixanol, CsCl, affinity, IEX, and characterisation by qPCR, ELISA, Western blot. Salaries are expected to be in the 35-38k range.

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  • QC Senior Technologist

    Salary: £34000 Location: Salisbury

    My client is a fast-growing biopharmaceuticals company based in the South-West of England. Experts in developmental production and the bringing to market of biologicals, my client have decades of experience in production, characterisation, process and analytical validation of life saving biopharmaceuticals, including the Anthrax Vaccine. Taking on the mantle of QC Senior technologist will see you reporting directly to the QC Analytical Manager. You will be tasked to manage and perform the transfer/validation of analytical methods from Development into a GMP environment in QC Analytical Services (QCAS). The role involves all activities involved in transferring analytical methods from Development to QCAS, including running analytical methods in both Development and QCAS, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports, performing release analysis and training existing members of staff in transferred methods. Are you prepared to begin a new chapter in your career? If so, this could be the role for you.

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  • Quality Systems Officer

    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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  • Validation Specialist

    Salary: £45000 Location: Oxford

    I am currently recruiting for a Validation Specialist to join a world-renowned biopharmaceutical company; this company specialises in developing innovative gene-based medicine and therapeutic vaccines. This exciting about has come about due to the year-on-year growth and are now in a position to bring a talented Validation Specialist to join the team in their Oxford based site. This person will support GMP manufacturing and laboratory facilities by ensuring all aspects of validation (manufacturing & laboratory equipment, facilities and utilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are complete and up to date. The Validation Team also represent the business in customer audits and regulatory inspections to demonstrate compliant systems. + Ensure compliance with regulatory requirements and Quality Management System by supporting/assisting Validation Manager in performing and managing qualification and validation studies of GxP critical systems, equipment and processes. + Generate validation documentation including master plans, validation assessments and test protocols; execute qualification/validation protocols/studies + Ensure Validation Department provides timely, appropriate and expert advice on qualification and validation issues to Manufacturing, QC/QA & Engineering and other company functions as required + Supporting the validation of equipment, facilities, utilities and processes in accordance with GMP requirements and a lifecycle approach in coordination with multi-functional Validation + Represent the Validation Department during client audits and regulatory inspections ***What the Validation Specialist needs*** + Demonstrable validation experience in a biopharmaceutical, pharmaceutical or related industry including Manufacturing/Laboratory Equipment, Facilities & Utilities Qualification (URS, DQ, IQ, OQ & PQ) + Broad knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines including GMP, GDP, GLP, GEP + Experience of aseptic processing and cleanrooms highly desirable + Computer Systems Validation (CSV) would be advantageous + Educated to degree level in Science (Biological) ***What the Validation Specialist will get*** + Competitive salary + excellent benefits + Work in a fantastic state-of-the-art facility + Lots of training and development opportunities If this sounds like the perfect role for you, then please get in touch today!

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  • Senior Downstream Processing Scientist

    Salary: £45000 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 currently helping them to recruit a senior downstream scientist within their process, research and development team. Candidates will be recognized experts in downstream processing including bioprocess design, protein expression and purification. They will be primarily involved in purifying and characterizing a variety of therapeutic candidates in support of projects from early stage research to pre-clinical programs. Process, Research and Development works with the companies research teams involved in vector and cell engineering to ensure the seamless transfer of processes from research to manufacturing. The scope of work may include, but are not limited to vector purification, novel purifications, purification process development and verification, technology assessment, data analysis and project reporting. The individual must have a demonstrated ability to work independently and to manage multiple projects either through direct supervision or in collaboration with the programme team. The individual must be innovative and creative, show initiative, collaborative ability and have good general science management skills. Applicants are expected to have excellent time management skills, with the ability to adapt to rapid changes in projects priorities and meeting aggressive timelines. The individual should also enjoy working in a team setting and be able to work well with both research scientists and as well as external collaborators. Salaries for the senior downstream processing roles are expected to be in the 40 to 45k range.

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  • Analytical Scientist (PR&D)

    Salary: £38000 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 analytical scientist within their process, research and development team. Candidates should have the following skills and experiences; + An undergraduate degree (or equivalent-level qualification) in a Life Sciences or Biotechnology-related subject + Good aseptic techniques + Knowledge of general cellular and molecular biology laboratory techniques + Practical experience of a range of bioprocess analytical techniques (such as cell-based assays, FACS based assays, nucleic acid extractions, qPCR, SDS PAGE, Western blot analysis, ELISA, HPLC, etc.) + The ability to work in a high paced team environment and to, meet challenging deadlines + Demonstrated ability to work independently as well as in a team setting + Strong written and verbal skills Salaries are expected to be in the 35-38k range.

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