• Regulatory Affairs Director 5/14/2018 12:00:00 AM

    Salary: £90000 Location: CAMBRIDGE

    Director, Regulatory Affairs- Biotechnology- Cambridge- ExcellentSalary Based in Cambridge, my client is a market leader in human anti-body development for the immuno-oncology, inflammation, haematology and infectious disease sectors. Due to business development, they are currently looking for an experience Director of Regulatory Affairs with Significant industry/biotech experience of early-phase clinical trials You will be responsible for providing strategic guidance for the business in the development of new antibodies and to lead the company in all matters relating to regulatory affairs. Minimum of BSc in appropriate scientific field Significant industry/biotech experience of early-phase clinical trials Expert level of knowledge in regulatory affairs Knowledge of Development Good Practices (GxP) Excellent salary- to be discussed at application Great benefits

  • X-Ray Software Developer and Crystallographer 5/14/2018 12:00:00 AM

    Salary: £55000 Location: CAMBRIDGE

    X-Ray Software Developer and Crystallographer - Cambridgeshire - £55k + Assistant Director level + Excellent salary and benefits package + Software development / coding My client is a global leader in drug discovery and development for oncology. They now seek an expert-level X-Ray Software Developer and Crystallographer to join their molecular sciences department. Youll have a PhD and substantial industrial experience in macromolecular crystallography as well as writing code in web-based programming languages. The benefits will include a fantastic package and career development opportunities at a highly successful Pharmaceutical company: + Salaries from £55,000 (flexible depending on experience) + Full benefits package

  • Shift Engineer 5/14/2018 12:00:00 AM

    Salary: £34000 Location: ROMFORD

    Shift Engineer - Pharmaceuticals - London - 34K + Shift Allowance My client is a leading specials manufacturer based in the South of England. Due to their continued expansion they are currently looking to hire an experienced Shift Engineer. The ideal candidate should have a strong background working within the pharmaceutical sector. You must have a background working in an engineering discapline. A strong understanding of GMP standards is essential. You must have worked with PLCs and have a strong working knowledge of building services including HVAC. Experience writing SOPs would also be an advantage. The successful candidate will join a busy engineering team on a shift basis. You will benefit from; + 30-35K basic salary + Excellent Benefits Package + Great Career Opportunities

  • Assay Biologist 5/14/2018 12:00:00 AM

    Salary: £40000 Location: CAMBRIDGE

    Assay Biologist - Cambridgeshire + Screening assays for drug discovery + Biochemical assay development + Great perm role with benefits My client is a global leader in drug discovery and development for oncology. They are looking for new Assay Biologist to join their teams for assay screening on small molecules. Youll be responsible for developing biochemical screening assays for drug targets and exploring new assay technologies. You will need a PhD and relevant experience in protein biochemistry / enzymology. The benefits will include a fantastic package and career development opportunities at a highly successful Pharmaceutical company.

  • PI Buyer 5/14/2018 12:00:00 AM

    Salary: £25000 Location: SLOUGH

    My client, based in Berkshire, has established themselves as a leading distributor in Japanese market and supply to currently to 13,000 customers. After careful consideration they have now decided to join the UK Market and expand their portfolio of clients. They are committed to supplying Pharmacies, Doctors, Hospitals and Wholesalers with the Highest Quality Branded and Generic Pharmaceutical products at the most competitive prices, together with a comprehensive range of ancillary products. Dedicated to the principles of best practice and high quality in all its activities, particularly in supply and service to its customers, for my client it will always be a pleasure to deal with their customers. My client is committed to support and development of staff, Systems and Working Relationships as this will lead to great work, enthusiasm and loyalty which is the key to achieving its primary mission. Due to this continued ambition, my client now seeks to hire an experienced PI Buyer. Responsibilities • Supporting Purchase of pharmaceutical products from EU countries. • Maintain a database of information relating to potential new products. • Maintain records of stock usage through sales to ensure price lists are correct and up to date. • Obtain information on potential new products and locate the cheapest sources. • Work cooperatively and effectively with the Regulatory affairs department on all issues associated with licensing products. • Entering Purchase order to the system and ensure invoice are sent in a timely manner for contract labelling. • Opening products codes in the system. • Preparing offers lists to suppliers. • Report to related parties with purchase of products that need attention (control drugs, temperature control products) and liaise with warehouse to store correctly. • Arrange shipment and make sure the goods to be delivered in a timely manner. • Monitoring and keeping records of shipment schedule (ETD and ETA). • Liaise with carriers and negotiate on rates. • Calculating profit margin of Purchase order and Blanket order. • Create various purchase reports and analyse purchase cost and profit. • Checking and matching purchase invoices against purchase orders. • Liaise with finance team, warehouse and production to handle with damage/shortage goods from supplier and take a necessary action. • Liaise with finance team to update purchase record. • Check stock levels. • Filing documents. • Other ad hoc task The Candidate • Graduate Qualification. • Able to use Microsoft Excel to a good standard. • Able to use Microsoft Word to a good standard. • High level of communication. • Able to work without supervision. Salary is negotiable on experience

  • Quality Compliance Manager 5/14/2018 12:00:00 AM

    Salary: £45000 Location: CAMBRIDGE

    The Client My client provides proprietary technologies and complementary services to organisations involved in the development of biopharmaceutical products. Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, my client supports the development and manufacture of better treatments for patients The Role To lead and manage the Company’s Quality Management system and ensure that the Company is compliant with legislative and regulatory requirements in respect of scientific work undertaken. To develop and maintain a Quality Management System (QMS) to ensure that the company complies with legislative and regulatory requirements and best practices, particularly with respect to the use, storage and disposal of: - • Human tissues • Radioactive materials • Genetically modified organisms (GMO) • Other hazardous materials, including toxins and cytotoxic compounds Responsibilities • To oversee the application and/or maintenance of the Human Tissue Act (HTA) licence, Research Ethics Committee (REC) approvals (for the use of human tissues) and notifications under the GMO and radioactive waste regulations • To monitor the legislation and regulations applicable to the company’s scientific activities and implement any changes required to ensure that the company remains in compliance • To develop and maintain a Company database of COSHH forms and Risk Assessments and ensure staff are aware and adhering to them • To develop and maintain a database of Material Safety Data Sheets (MSDS) and ensure that a MSDS is available for all materials that are being used • To develop, implement and manage the Company’s scientific document retention policy • To develop a plan for implementing ISO9000 compliance in Cell Line Development • To develop and implement a plan to allow GMP compliant sub-contracting within the Group companies including any GMP analytical services carried out in Cambridge • To develop and maintain the UK Company’s QMS and where appropriate ensure this is aligned with US groups • To lead the development and implementation of new SOPs and ongoing review, revision and replacement of SOPs • To identify and develop ways to improve quality across the Company and ensure best practice is adopted throughout the organisation • To conduct regular internal audits for compliance with the legislation, regulations and the QMS and ensure that corrective and preventative actions (CAPA) are implemented and provide a written report of such audits and the CAPA to the Board Audit & Compliance Committee • To ensure that external audits under scope of this role, including by regulatory agencies, are prepared for • To undertake any other duties relevant to the position and level • To effectively manage one or more teams and, through the performance management system, provide guidance and support associated with both their technical and personal development • To foster relationships with key internal and external stakeholders and partners to support proactive compliance with legislation and regulations and the Company’s QMS • To take the lead in providing training to staff to ensure that they are aware of the legislation, regulations and best practices that affect their work and what they need to do to comply with them • To be a member of the HTA Governance Committee The Candidate • Experience of working in a regulated environment • Familiarity with Quality Systems including EU GMP • Experience of developing and/or maintaining a QMS and of conducting audits • Excellent interpersonal skills, including tact and the ability to foster good relationships • Planning and Organisation • Able to effectively plan and organise own work load and that of small teams of reports • Communication • Excellent communication skills, including the ability to write clearly and unambiguously to Regulatory standard • Focused to achieve results • Critical and intelligent attention to detail and high standard of accuracy in own work • Desirable Skills & Qualifications • A higher degree within the Life Sciences • Understanding of scientific research • Working experience of the Human Tissue Act • Experience of working within a GMP regulated environment Salary is negotiable on experience

  • Quality Control and Analytical Chemistry Manager 4/19/2018 12:00:00 AM

    Salary: £50000 Location: SHEPHERDS BUSH

    The Client My client, based in London, is a global leader in specialist imaging working towards the understanding of disease and translational drug development. The Role Due to company progression, they are looking for an experienced and time served Analytical manager. Responsibilities Reporting to the head of clinical chemistry, you will be responsible for leading a multidisciplinary team of 6 specialists with in a GMP facility, in analytical chemistry and microbiology. This position requires an individual to lead by example and demands someone with strong people management, technical expertise and effective communication skills. • Managing and leading a multidisciplinary team of highly specialist PET analytical chemists, microbiologist and lab technicians, and ensure they are fully trained and competent for their roles • Managing the daily activities in the QC laboratories for the delivery of PET products to support clinical demands • Releasing PET radiopharmaceuticals for human use • Leading analytical method development for implementation of all new PET radiopharmaceuticals for human use • Overseeing management of Raw Materials entering the manufacture of clinical batches of radiopharmaceuticals • Overseeing the environmental monitoring program, in conjunction with the microbiologists. • Identifying and implementing opportunities for continuous improvement in the QC laboratories. • Ensuring the QC laboratories, equipment and analytical methods are fully functioning and compliant and conform to company standards and the appropriate regulatory standards in the UK The Candidate • Minimum BSc. Degree in Analytical Chemistry • Operational expertise of laboratory equipment • Knowledge of relevant legislation and regulations • Strong people management skills • Good project management skills • Demonstrated ability to work in a multidisciplinary team and to assimilate a working knowledge of areas outside of their core competency. • QP qualification (desirable) Salary is negotiable on experience

  • CSV Validation Technologist 4/19/2018 12:00:00 AM

    Salary: £34600 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. The Role The purpose of this role is to lead CSV validation on investigational activities, in support of medicinal products, regulatory inspections and in the provision of technical customer support. Responsibilities • Lead the site as subject matter expert with respect to ensuring Computer Systems Validation activities are undertaken in accordance with the Validation Master Plan, Validation Policy and Process Validation procedure. • Write, review, approval CSV validation protocols prior to execution and report generation. • Coordinate with stake-holders the timely completion of validation studies, managing expectations and meeting targets. • Assess Change control documentation to determine change impact with respect to the validation status and report appropriately. • To lead CSV discussions during audits. • To support operational areas in the implementation of change. • To ensure stake-holder expectations are management and that projects are delived to current GMP and PBL standards. • To ensure the timely completion of Deviations and the closure of CAPAs. Salary is negotiable on experience

  • GMP Biotech Production Manager 4/19/2018 12:00:00 AM

    Salary: £50000 Location: MOTHERWELL

    GMP Biotech Production Manager - Bio- Pharma Based in Scotlands central belt, my client is an innovative cell-based production company, specialising in Virology and oncology treatments. Due to continued expansion, they are actively seeking a GMP experienced Production Manager with a solution focused and positive approach. Working within a GMP environment, youll be responsible for managing a team of experienced Scientists, and promote high standards of production. Your excellent attention to detail will encourage your staff to continuously work to high standards. You will have- Minimum of BSc in life sciences subject Experience of working as a Production Manager with in a GMP facility. Experience of dealing with live vaccines or Human Cell Cultures Youll receive a highly competitive salary, an attractive benefits package, and professional development opportunities. If you have the right mix of skill, experience and attitude please email or call 0161 923 8172 and ask to speak to Nathan

  • Senior QC Analyst 4/19/2018 12:00:00 AM

    Salary: £35000 Location: MOLESEY

    My Client are a manufacturer and distributer of unlicensed medicinces based in the South West of London. They are looking for an experience QC Analyst to support the business and their clients. Duties include: ++ Sampling and testing of raw materials and finished products using current Pharmacopeia’s ++ Generating reports and protocols to manage the QC Lab ++ Being the go to subject matter expert for regulatory bodies during audits. ++ Leading OOS, deviations, change controls or any other quality record relating to QC. ++ As well as undertaking any other duties which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood. You will also be given the training for the day to day supervision and management of the QC laboratory. Salary:- up to £35,000 per annum If you are an experienced Analyst with a background in pharmaceutical analysis and are interested in this role, please send your CV to


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