• Quality Assurance GLP Lead Officer 10/1/2018 12:00:00 AM

    Salary: £30000 Location: Bradford

    My client is a knowledge based, science led business focused on delivering the expertise and capabilities our clients demand. They work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical and chemical; and consumer products sectors. Due to substantial business growth my client has recently implemented Regulatory Good Laboratory Practice (GLP), resulting in having a brand-new opportunity to join the business as a Quality Assurance GLP Lead Officer. This is a full-time permanent position based at our site in Bradford. The Quality Assurance GLP Lead Officer role is to further develop and maintain the Quality Assurance Programme for GLP, perform the independent monitoring for GLP compliance. This role is also required to take the lead and impart their GLP knowledge to the current in- house QA team in GLP auditing. Main Duties to: Maintain the Quality Assurance Programme for GLP studies. Perform and train/mentor other members of the QA team in all aspects and types of auditing required to maintain compliance for GLP work performed. Prepare and issue Quality Assurance Statements. Develop, write and review Quality Assurance Standard Operating Procedures. Review SOPs for compliance with principles of GLP, as required. Maintain audit programmes, scheduling and conduct external audits (as required). Advise management of any deficiencies in Regulatory Requirements. Host or partake in Client and Regulatory visits as appropriate. Liaise with site personnel to ensure a full understanding of regulatory requirements. BSc in chemistry or related subject. Extensive experience in Regulatory GLP auditing. Clear communication both written and verbal is essential as the role involves communication with internal and external Stakeholders at all levels within the business. Presentation skills in order to deliver training and Regulatory knowledge If you are interested in this role then please contact Robert Frame on 0161 923 8189

  • Project Manager 9/26/2018 12:00:00 AM

    Salary: £42230 Location: Salisbury

    My Client is a leading manufacturer of biopharmaceutical products and with a rich history of pharmaceutical development in vaccines and therapeutics they are looking for an outstanding project manager to join their team. Job Summary To formulate proposals for and to provide active management of operational projects with responsibility for ensuring all aspects of project delivery for both the company and its customers. Responsibilities Act as an internal project champion and customer for a specified product(s) or application(s) and maintain current understanding of; ? The production processes and associated analysis. ? Production and testing costs. ? The regulatory environment and impact on the product. ? The product application. ? The market place and understanding of risks to income. ? Competitor activities. ? Potentially competing technologies/patents. ? Seek potential collaborations to enhance income/efficiency or cost Reductions. ? Work to schedule product manufacturing to free capacity. Be the focal point for all project communication, ensuring project sponsors, stakeholders and team members kept appropriately informed. Establish and set budgets for operational projects as part of the annual budgeting process and as appropriate. Develop and maintain detailed plans to assure efficient delivery of complex projects. Support Business Development in developing the customer relationship pre-contract and then post contract signature act as the primary customer interface Manage contract organisations to ensure product quality and high service level Conduct quality reviews of projects to identify best practice and improvement areas to be addressed Support the commercial function in developing the customer relationship precontract, activities include customer liaison, assistance in negotiation, prompt delivery of reports and other information as needed. If you are interested in applying for this position then please get in touch with Robert Frame on 0161 923 8189

  • Senior Scientist - DMPK 8/23/2018 12:00:00 AM

    Salary: £0 Location: Slough

    Berkshire- Senior Scientist – DMPK- Permanent My client is a global biopharmaceutical company focused on drug discovery for the treatment of severe diseases, affecting the immune and central nervous systems. Due to a fantastic period of continued growth they are currently looking for senior DMPK scientist to work within the iADME group responsible for DMPK input to both NCE and NBE projects from early discovery to submission. This role is a lab-based position and requires the right candidate to make expert opinions on in vitro DMPK issues and translation to in vivo as well as to humans. The role will champion and develop new scientific strategic directions and guides or contributes to development of new assays. You will have: Ideal candidate will be educated to PhD level (or equivalent) with postdoc/ industrial experience or MSc or BSc (or equivalent) with extensive experience in DMPK. Strong Knowledge of pharmacokinetic concepts is essential, and experience in a variety of DMPK assays and techniques (in vitro, ex vivo and in vivo) is preferred. Fantastic salary (depending on experience) Great development options Chance to be part of a multinational company with global opportunities

  • Scientist – Process Development (Downstream) 8/20/2018 12:00:00 AM

    Salary: £0 Location: Oxford

    The Client 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 aims to be both innovative and entrepreneurial in everything they do – Will you join them and contribute to this exciting journey? The Role You will be involved in a range of internal platform development and commercial projects, focusing on establishing process development capabilities for the production of both therapeutic proteins and viral vectors for gene therapy applications. My client has a number of on-going programmes in this area, and multiple government supported grant awards, which the recipient will contribute towards. The Process Development Scientist (Downstream) will work together with Scientist colleagues to specify and implement scalable processes for primary recovery and product purification. 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. Prior experiencing of using relevant techniques, including TFF, ultracentrfugation and AKTA-based chromatography (Affinity, IEX and SEC) is absolutely required, as is experience in developing and implementing associated process for mammalian production systems. The position will work closely with the Cell Line Development, Upstream Process and Analytical teams, and will report to the Chief Technology Officer. Responsibilities • Lead, plan and conduct primary recovery and purification experiments including use of statistical approaches for process design and specification (DOE, QbD) • To support technology transfer activities for commercial manufacturing • To work closely with internal and external stakeholders to define project goals and deliverables, in line with planned project objectives • To keep up to date with the scientific literature and developments in the field • Set an example to other colleagues, and to train and mentor junior staff • Perform data analysis, author Standard Operating Procedures and write technical reports • Support and contribute to protection and assessment of intellectual property • Promote and suggest implementation of new methods, technologies and processes to ensure best practice • To ensure established quality standards are strictly adhered to, across all on-going activities Salary is negotiable on experience ---- For more information and a confidential discussion, please contact Kieran Whittaker on the below: - Tel: 0161 923 8174 Email:

  • Research Technician Microbiology 8/20/2018 12:00:00 AM

    Salary: £24000 Location: Aberdeen

    My client is a leading pharmaceutical company focusing on developing live biotherapeutic products from the human gut microbiome. So far, my client has two clinical stage programmes in IBS and IBD as well as a strong pipeline of pre-clinical programmes in autoimmunity, inflammation, oncology and CNS disease. Due to recent expansion, my client is looking for a Research Technician to provide microbiology support in performing characterisation of bacteria and preparing cultures for screening assays and preclinical studies. Practical experience in microbiology lab techniques and aseptic techniques are essential. Experience / Qualifications Required • This position has a minimum requirement of a HND in microbiology, biochemistry, biology, or biomedical sciences or relevant experience • Competency in a variety of microbiological laboratory techniques • Experience with bacterial culturing techniques, including strict anaerobes would be advantageous • Ability to follow SOPs and an accurate way of working in the laboratory • Excellent organisational skills and accurate record keeping, attention to detail

  • Control and Instrumentation Engineer 8/13/2018 12:00:00 AM

    Salary: £29355 Location: Salisbury

    My client is a leading developer and manufacturer of life saving pharmaceutical therapeutics and vaccines. The client performs a range of breakthrough production, quality and development roles within the pharmaceutical production process. The client is looking for an effective communicator who has GMP experience and can work to a high standard. The candidate would ideally need to be highly organised as well as the ability to work within a team. Pharmaceutical industry experience is desirable. MAIN DUTIES AND RESPONSIBILITIES •Responsible for the troubleshooting and liaising with Engineering and maintenance technicians to establish route cause, develop and manage appropriate corrective action plans and report. •Instigate and manage improvement projects, in particular those relating to control and automation systems. This shall include delivery of software improvements in full compliance with GAMP. •Maintain compliance of the Engineering owned Data Acquisition Systems including ensuring suitable provision and execution of GMP compliant operational and administration policies and procedures. •Manage the contracted specialist support in delivery of the Engineering Service in support of Control and Automation Systems. •Coordinate the delivery of the Preventive Maintenance and Asset Care Plans with the Instrumentation Manager and maintenance scheduling resources. •Represent the company as a Engineering subject matter expert for Control and Automation systems in Regulatory Audits and in the delivery of Capital projects.

  • Manufacturing Development Scientist 8/8/2018 12:00:00 AM

    Salary: £35000 Location: Hampton

    My Client has established a high quality DNA manufacturing platform technology, using an in vitro enzymatic process and has a role available for an experienced process development scientist in its expanding Manufacturing/CMC Development Group. The successful applicant will play an important role in product specific development of dbDNATM manufacturing processes. This will involve working in a team focussed on establishing critical parameters and controls using design of experiments approach; industrial scale up and technical transfer of processes to third parties/GMP manufacturing organisations. This new role presents an exciting opportunity, with the successful applicant being involved in a range of process development projects. Essential: • A PhD level qualification in Biochemistry / Protein chemistry / Molecular Biology or equivalent industrial experience. • In addition, experience of CMC/process development in a pharmaceutical setting?. • Familiarity with standard bioprocessing techniques, such as chromatographic and filtration methods of separation. • Familiarity with standard Molecular Biology techniques such as cloning, PCR, mutagenesis and in related specialised DNA characterisation techniques. • Experience in keeping accurate and thorough records of laboratory experiments. In addition, experience of writing technical reports to a standard suitable for submission to regulatory authorities. • Applicants must be reliable, enthusiastic and self-motivated as well as having excellent communication skills and an ability to learn new techniques. • The ability to work well in a team environment and balance workload demands is vital.

  • Research Scientist (Discovery I (Host) Team) 8/7/2018 12:00:00 AM

    Salary: £34000 Location: Aberdeen

    Based in Northern Scotland, my client is a world leader in developing therapeutics from the human gut microbiome for the prevention, treatment or cure of disease; specifically, autoimmunity, inflammation, oncology and CNS disease. Due to continued growth they are looking for a Scientist to join their Discovery I Host team. The primary focus of the team is to perform high-throughput screening assays investigating host-microbe interactions for the identification of new LBPs in different therapeutic areas. You will need to be Proficient in running a variety of cellular and molecular techniques are required along with independent and flexible working. You will also be responsible for writing reports, SOPs, contributing to writing papers and presenting at internal and external meetings. You will need: PhD in molecular biology, biomedical sciences, or other science-related discipline or HNC with a minimum of 5 years industry experience. Experience in gut biology and/or mucosal immunology Competent in assay development, cell culture techniques and variety of molecular laboratory techniques, including qPCR or flow cytometry or imaging techniques. Salary- up to £34,000 (dep on experience). Fantastic development opportunities Great Benefits Excellent working environment

  • Equipment Validation Manager 8/1/2018 12:00:00 AM

    Salary: £0 Location: Salisbury

    QA Compliance Officer - Audit The Client 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. The Role Taking on the mantle of Equipment Validation Manager will see you take the helm of validation activities for Equipment and Systems. You will be responsible for both Permanent and Contractor resources as well as project meetings, review of technical documents and ensuring strict compliance to GMP regulatory requirements. Responsibilities • Coordinate and manage the timely delivery of validation activities • Review and approve validation documentation • Line management of both permanent and contractor resources • Ensure Validation procedures and activities are aligned with current GMP regulatory Requirements ----- Are you prepared to begin a new chapter in your career? If so, this could be the role for you! For more information and a confidential discussion, please contact Kieran Whittaker on: - Tel: - 0161 923 8174 Email: - Salary is negotiable on experience

  • QA Compliance Officer - Audit 7/30/2018 12:00:00 AM

    Salary: £0 Location: Salisbury

    The Client 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. The Role Taking on the mantle of QA Compliance Officer - Audit You will be charged with formulating proposals for and provide active management of operational projects with responsibility for ensuring all aspects of project delivery for both the company and its customers. Responsibilities • To organise, plan and perform internal and external (supplier) audits, to follow up open audit reports and conduct reviews of audit responses in order to close out audit reports • To ensure supplier questionnaires are satisfactorily completed by key manufacturers and suppliers in a timely fashion. • To liaise with suppliers to obtain relevant information for their approval to provide key materials and services (incl. processing, BSE/TSE) • To approve GMP Monographs to ensure that suppliers are appropriately approved and BSE/TSE certificates are satisfactory. • To produce Quality Technical Agreements for the supply of and services from critical suppliers • To initiate and progress Supplier Complaints to closure. • To update the supplier monitoring database and associated spread sheets used for tracking. • To assist with the QA overview of manufacturing and testing areas. • To provide KPI reports measuring the performance of the systems and the team. • To undertake relevant training. • To undertake work in accordance with the Health and Safety policies and procedures and to work within any Quality Systems that are applicable to the site. • To comply with policies and procedures ----- Are you prepared to begin a new chapter in your career? If so, this could be the role for you! For more information and a confidential discussion, please contact Kieran Whittaker on: - Tel: - 0161 923 8174 Email: - Salary is negotiable on experience


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