Pharmaceuticals

  • 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

    View
  • PI Buyer 4/19/2018 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

    View
  • Key Account Executive 4/19/2018 12:00:00 AM

    Salary: £20000 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 continued ambition, my client now seeks an experienced Key Account Executive to join their team and help expand their portfolio in the UK market. Responsibilities Key account management: • Develop/ maintain relationships with current portfolio of major clients/customers to ensure they do not turn to competition. • Serve as the link of communication between key customers and internal departments • Resolve any issues and problems faced by customers and deal with complaints to maintain relationship. • Maintaining records/reports as per customer requirement which will be used during customer audits and monthly reconciliation of customer stocks. • Preparing relevant stock reports and attending audits as per schedule. • Providing regular and updated information to customer in regards to license variation. • Updating customer with new license granted so that they can send stock for labelling. • Quoting labelling fee to customers provided by the Purchase manager/ Head of Purchasing • Request delivery schedule for customers so that internal department can coordinate work responsibilities accordingly. • Ensure that the products labelled are delivered to customers in a timely manner as agreed. Administration: • Supporting the purchase team with all administrative work responsibilities. • Entering purchase order /sales order to the system and ensure invoice are sent in a timely manner for contract labelling. • Opening products codes in the system. • Work cooperatively and effectively with the Regulatory affairs department on all issues associated with licensing products. • Report to related parties with receivable of products that need attention (control drugs, temperature control products) and liaise with warehouse to store correctly • Liaise with finance team, warehouse and production to handle with damage/shortage goods from supplier and take a necessary action. • Costing new products for new license application as per information provided by Purchase manger. • Calculating profit and margin of Purchase order and Blanket order. • Create various purchase reports and analyse purchase cost and profit. • Filing documents • Other ad hoc tasks 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

    View
  • Project Manager 4/19/2018 12:00:00 AM

    Salary: £50000 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 Project Manager will see you reporting directly to the Head of Project Management & Logistics 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 • Provide active management, of a portfolio of assigned manufacturing-related projects and to have prime responsibility for operational liaison with project customers, both internal and external, to ensure completion of projects to high standards and to develop the company’s reputation and relationships. To be done in line with the policy on Project Management. To include, but not be limited to, pharmaceutical products (vaccines & therapeutics), technology transfer and process development, facility shutdowns and start ups and capital bids. • Responsible for evaluation of assigned external and internal project enquiries for manufacturing activities to negotiate and finalise project definition, formulate proposals for resources and programmes required for project delivery. • To be focal point for all project communication, ensuring project sponsors, stakeholders and team members kept appropriately informed. To communicate highly complex, sensitive and contentious information whilst overcoming barriers to understanding. Routinely reporting to line manager monthly and by exception. Formal presentations to various groups including executive management are expected. Ongoing liaison with research, development and regulatory groups is also an element of the role. • Establish, in conjunction with line management, operational project teams. To provide leadership, manage relationships and motivate the teams throughout the project life cycle. Typically the team would comprise department managers or deputies from functional areas typically QC, QA, Production and Development and others as required each with authority for management of their own staff, facilities and other resources to deliver project activities. The project manager will agree activities, delivery dates, set the priorities for the team and address conflicts. Project manager would organise review of data and lead analysis and interpretation including making final decision where required. • Establish and set budgets for operational projects as part of the annual budgeting process and as appropriate. To capture and manage changes to scope and costs to ensure projects operate within agreed margins. As budget owner management of budgets including periodic review of actual cost against budget with review of significant discrepancies. Interrogation and analysis of budgets with the view to drive costs down without unknown adverse affects on product quality or delivery. • Develop and maintain detailed plans to assure efficient delivery of complex projects. Ensure project risk register is in place in the approved format and in a timely manner. Develop contingency plans as appropriate and communicate risk. Organise project management and review systems and as problems arise ensure rapid and effective resolution through the project teams or through escalation up departmental line management. • Support Commercial function in developing the customer relationship precontract, activities include customer liaison, assistance in negotiation, prompt delivery of reports and other information as needed. Effective management of other functions to obtain information usually against tight deadlines is a feature. • Post contract signature full professional customer management acting as the primary customer interface ensuring customer satisfaction by delivery against plan or in case of problems effective communication. • Undertake all assigned work in accordance with the company’s Risk Management Systems, policies and procedures. Implement safety policies across the manufacturing functions not limited to but including the coordination safety check list which addresses HSE requirements for safety risk assessments and standard protocols for each project. • Conduct quality reviews of projects to identify best practice and improvement areas to be addressed. Apply continuous improvement to improve the operational performance. Provision of project specific KPIs and other required metrics as required. • Contribute to and if requested take ownership of the high level scheduling of the entire BPL portfolio. Acting as a focal point and in collaboration with the other project managers recommend modifications required to optimise the delivery of the portfolio to the Head of Project Management and Logistics. Update the plan monthly or as required and circulate as appropriate. The high level schedule optimises the use of facilities and staff across manufacturing whilst clearly indicating unit capacity. • Manage contract organisations to ensure product quality and high service level. Management and facilitation of audits and communication between the two organisations is a key component of this. • Act as an internal project champion and customer for a specified product(s) or application(s) and maintain current understanding of ; o The production processes and associated analysis o Production and testing costs o The regulatory environment and impact on the product o The product application o The market place and understanding of risks to income o Competitor activities o Potentially competing technologies/patents o Seek potential collaborations to enhance income/efficiency or cost reductions o Work to schedule product manufacturing to free capacity for 1) additional new work 2) cross staff working o Initiate and prioritise margin improving projects • In line with overall responsibilities, to perform any other tasks assigned or objectives set by the line manager. • Deputise for Head of Project Management & Logistics, as required. Salary is negotiable on experience ----- 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: - Kieran.whittaker@wearenorthpoint.com

    View
  • Unit Manager 4/19/2018 12:00:00 AM

    Salary: £34000 Location: SALISBURY

    Unit Manager – Microbiology & Manufacturing- Wiltshire- up to £35k Closing Date: 28th February Based in Wiltshire my client is a leading bio-pharmaceutical development and manufacturing company. Due to retirement they are looking to take on an experienced Unit Manager. The role will focus on delivering projects related to biopharmaceutical manufacturing within a commercial and regulated environment. The successful candidate will have a strong blend of microbiology and technical services management. You will have- *BSc or higher in Biological, Chemical or life sciences field *Have unit management experience in a commercial, regulated, pharmaceutical company *Extensive experience of ACDP containment levels 2 and 3, experience of GMP, microbiology testing and managing small teams. You will be responsible for- Unit management and support of GMP manufacture of pharmaceutical products. Salary up to £35,000 dependant on experience Excellent development opportunities

    View
  • Process Engineer 4/19/2018 12:00:00 AM

    Salary: £40000 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. The Role Taking on the mantle of Process Engineer will see you as the System technical expert for all Engineering Utilities systems within the GMP Envelope. You will be responsible for identification of and managing small projects/initiatives relating to utilities systems and interfacing with the wider Engineering group to ensure Utilities systems within the GMP envelope remain compliant with current Good Manufacturing Practice. Additionally, the Process Engineer may work within an Integrated Process Team to provide operational support to the manufacture of biopharmaceutical products. You will become the Subject Matter Expert for all Critical Utilities (e.g. WFI, Clean Steam, and Purified Water) systems within the Pharmaceutical Production Envelope. As such you will interface with key stakeholders including equipment users, capital project managers, and the site principal maintenance contractor, to ensure these critical systems remain in compliance with best industry and regulatory practice. As a core member of an Integrated Process Team you will provide operational engineering support to the manufacture of biopharmaceutical products alongside other core members from the Production and Quality functions. You will have delegated responsibility from the Director of Engineering to design, manage and deliver process improvement projects and represent the group in the delivery of major facility expansion/refurbishment projects. Responsibilities may include: - Design and implementation of Process Engineering improvement projects Main point of contact for Engineering issues for the Fermentation Process Plant. Responsible for troubleshooting and liaising with maintenance technicians, engineers and users to establish the root cause, develop and manage appropriate corrective action plans and for failures - performance issues relating to the Utilities systems and process equipment (i.e. fermenters, centrifuges, CIP systems, autoclaves, HVAC, effluent systems). Planning and execution of site shutdowns. Supervision of Junior Chemical Engineers Attending and representing the company in FATs, SATs and commissioning for Utility Systems and Process Equipment. Provide engineering support to Capital Project teams (i.e. design reviews, HAZOPs). Writing, and reviewing User Requirement specifications for new equipment, SOPs, and generation of design documentation related to Utilities systems and process equipment within the GMP envelope. Responsible for owning Non-Conformances, CAPAs, Change Controls and Risk Assessments. Involved in FDA and MHRA Regulatory inspections. Are you ready to take on new responsibilities and begin the next chapter of your career? Salary is negotiable on experience ----- For more information and a confidential discussion, please contact Kieran Whittaker on the below: - Tel: 0161 923 8174 Email: Kieran.Whittaker@wearenorthpoint.com

    View
  • Head Qualified Person 4/19/2018 12:00:00 AM

    Salary: £80000 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 Head Qualified Person will see you reporting directly to the Quality Director on the delivery of autonomous and innovative Quality Management. You will be charged with being the primary contact for all QP to QP interaction with all client customers and partners as well as managing the QP group for the release of safe and efficacious products produced to the required Quality standard. As the Head Qualified Person, you will provide oversight and development for Quality Systems (including GxP), whilst ensuring you promote and uphold the highest standards of professionalism in order to grow the reputation of the company and ensure the best customer service for all internal and external contacts. Responsibilities • Lead and manage a team of QPs responsible for certification and release of licenced medicinal products and investigational medicinal products. • Ensure product is released in compliance with EU cGMP and the Product Specification File/marketing authorisation (or other where relevant). • Ensure the timely review of all Batch Manufacturing Documents in accordance with manufacturing schedules and product delivery dates. • Manage and execute the review of all deviations to assure the highest standards of compliance. • Coach and mentor company staff to improve problem solving and early problem resolution. • Coach and mentor other QPs within the team to enable them to meet the requirements of their roles. • Provide input and assistance with the development of relevant elements (Batch release processes) of the Quality Management System (QMS) within the business. • To review and approve documents within the QMS to ensure the requirements of Annex 16 are met by all QP’s. • To undertake audits in EU and third countries to ensure that sponsor manufacturing sites are operating in general compliance with EU GMP. • To provide advice and guidance to company staff and Customers regarding QP requirements within the EU. • Maintain up to date knowledge of the requirements of the Medicines Authorities across the EU and rest of world (where relevant). • Pursue a programme of continuous professional development in accordance with the requirements of QP registration and other statutory requirements. • Review Company Project Files (PSFs, commercial project files etc.) to ensure compliance with the current regulatory requirements and company procedures. • Provide Assistance with regulatory inspections and client audits. Salary is negotiable on experience ----- 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: - Kieran.whittaker@wearenorthpoint.com

    View
  • QC Senior Technologist (Method Transfer) 4/19/2018 12:00:00 AM

    Salary: £34000 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 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. Responsibilities • Utilising technical skills to validate specialised chemical and biochemical tests procedures to internationally recognised regulatory guidelines. Conduct problem solving investigations to resolve issues affecting Pharmaceutical manufacture. • Use technical expertise to be trained in and become a subject matter expert in methods being transferred. • Manage all activities involved in transferring analytical methods from Development to QC Analytical Services including running analytical methods in both Development and QC Analytical Services, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports and performing release analysis. • Perform release and stability testing of transferred methods. • Train out analytical methods within a GMP environment. • Work with project teams and represent QC on these to contribute to the success of these business centres by delivering the required Analytical knowledge and services. • Play a lead role with both internal and external customers. • Maintain an up to date awareness of regulatory and scientific developments via approved training courses and meetings that will contribute to the efficiency and effectiveness of laboratory working practices and aid personal development. • Authorship and review of SOPs, Protocols and Risk Assessments. • Involvement in audits both from internal and external parties • Write and review OOS investigations and deviation reports. Salary is negotiable on experience ----- 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: - Kieran.whittaker@wearenorthpoint.com

    View
  • 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

    View

« previous 1 2 next »