Two Scientists Win Largest Technology Award

As reported by the BBC News, two scientists have been awarded the Millenium Technology Prize for their scientific contributions to improving the quality of human life and in encouraging sustainable development.

Two Scientists Win Largest Technology Award in the WorldAwarded once every two years, the Millenium Technology Prize is the largest technology prize in the world. This is the first time the prize has been awarded to two scientists, Dr Shinya Yamanaka and Linus Torvalds. The two winners split the 1.2m euros prize.

Dr Shinya Yamanaka

Dr Shinya Yamanaka is a stem cell scientist who discovered how to program human cells to mimic embryonic stem cells. These cells can become any cell in the body. This is called induced pluripotent stem (iPS) cells. The scientists discovery will now contribute to the development of regenerative medicine.

Linus Torvalds

Linus Torvalds created a new open source operating system for computers.

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Patent Specialist (Food) – Cambridgeshire

Reena Dhana at CK Science is currently recruiting for a Patent Specialist in the food area to join a world leading Medical Device & Technology Organisation at their facilities in Cambridgeshire.  This is a contract role.

Responsibilities:

As a Patent Specialist your main responsibilities will involve patent searching, patent analysis and contextualising findings.

Qualifications:

To be considered for this Patent Specialist role you hold a BSc in Food Science, Life science, Engineering or a related subject (or equivalent). You will also have:

  • Extensive experience in the food industry is essential.
  • Good working knowledge of the patent system and the ability to analyse patents in the food industry is also essential.
  • A background in industrial scale food processing technologies is essential.
  • Expertise in cereals and grain, including processing, formulating and finished products including, but not limited to breakfast cereals and grain-based snacks would be advantageous.
  • Expertise in process equipment and conditions used to manufacture completed grain-based products is also advantageous.

How to apply:

Apply online for this job now

For more information or to apply for this Patent Specialist role please contact Reena Dhana on 01438 723 500 or email rdhana@ckscience.co.uk. Please quote reference ST23700 in all correspondence.

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Senior Brand Manager (Consumer Care) – UK

Reena Dhana at CK Science is currently recruiting for a Senior Brand Manager to join the Consumer Care division for a global pharmaceutical company based in Hertfordshire. This is a 6 month contract with a strong possibility of extension.

Responsibilities:

For this Senior Brand Manager role you will be responsible for leading and co-ordinating activities relating to the companies brand portfolio. You will be involved in developing and implementing promotional and non-promotional materials and programmes, managing external agencies to deliver brand activities (advertising, media, PR and digital). You will also be proactively liaising and collaborating with various UK functions, including Sales, Medical Affairs, Finance, Supply Chain and Regulatory Affairs, to ensure optimal alignment and effective implementation of business plans.

Qualifications and skills:

To be successful for this Senior Brand Manager role you will hold a BSc in Marketing or related subject (or equivalent). To be considerd you will need to have:

  • Previous experience as a consumer marketer is essential.
  • Previous experience of managing a full Profit and Loss for significant brands is also essential.
  • Previous experience of success in implementing brand activities across a number of media channels including TV would be advantageous.
  • Familiarity with PAGB code of practice is desirable.

How to apply:

For more information or to apply for this Senior Brand Manager role please contact Reena Dhana on 01438 723 500 or email rdhana@ckscience.co.uk. Please quote reference ST23657 in all correspondence.

                                                        Click here to apply online now

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Abbott to invest €85m at its pharmaceutical site

Abbott Ireland released plans to invest €85 million at its pharmaceutical manufacturing operation in Sligo, Ireland.  This investment will result in the creation of up to approximately 175 highly skilled jobs, these new roles will include  engineering, quality, pharmaceutical science and other science-based areas.

The majority of the jobs will be added during the construction phase and the remainder will come on stream post the completion of the expansion. In addition, construction employment will create up to 150 temporary jobs. The expansion of the facility will be completed in 2014. The investment is supported by the Irish Government through IDA Ireland.

Dr. Azita Saleki-Gerhardt, President, Global Pharmaceutical Operations, Abbott said  “Abbott has had a presence in Ireland for more than 65 years and began manufacturing in the country in 1974. Sligo is an important part of Abbott’s pharmaceutical manufacturing network and we are pleased to expand it to support future production needs. The success of our Sligo facility is due to the dedication of its staff and management. This state-of-the-art expansion will enable us to produce innovative therapies that we expect will represent significant advances in the treatment of cancer, chronic kidney disease and viral infections,”

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QA & Development Shift Manager – West Midlands

Victoria Walker at CK Science is currently recruiting for a Quality Assurance and Development Shift Manager to join a specialty chemical manufacturer based in the West Midlands. The company specialise in chemicals which have applications in a variety of markets, including electronics, automotive, flavours/ fragrances and more.

Responsibilities:

The main roles and responsibilities of this QA & Development Shift Manager will be to manage the provision of analysis of works products and day to day running of the laboratory. This is a key role in the site emergency procedure and responsible for ensuring health, safety and environmental compliance, you will supervise and co-ordinate work within the shift section. Other responsibilities are as follows:

  • Provision of certification for site products and the authorisation of certificates will be your responsibility, as well as development of methods and maintaining existing ones.
  • You will also be responsible for department safety standards, carrying out and maintaining department risk assessments and maintaining department instrumentation.
  • You will ensure that the QAD Shift Chemists are organized and will have customer contact regarding queries and complaints, certificates of analysis for site products
  • Deal with regulatory bodies amongst other external and internal contacts.

Qualifications and skills:

 In order to be considered for this QA & Development Shift Manager role you will have a minimum qualification of a degree in chemistry (or equivalent) which is an essential requirement for this position. Skills which are requi5red for this position are as follows:

  • Excellent communication and management skills are required.
  • The successful candidate needs to be able to motivate and develop individuals to meet the shift requirements through clear communication and direction.
  • The incumbent needs to be able to react calmly to emergency situations and be capable of making decisions under pressure.
  • A sound technical knowledge is required along with an in-depth knowledge of process operations and practical problem solving skills.
  • Shift work experience along with IOSH or experience with laboratory health and safety is desirable
  • Knowledge of Site Products, Process Plants and Raw Materials. Previous analytical experience involving phosphorus based chemicals would be a distinct advantage as well as use of wet chemistry (volumetric/ gravimetric) and instrumentation (titroprocessors, UV Visible spectrophotometer, atomic fluorescence, atomic absorbance, NMR, GC).

The job:

Please note that this QA & Development Shift Manager role involves working 12 hour day and night shifts on a 5 shift rota which covers the site 24 hours per day, 365 days per annum. This also includes providing cover in the event of absence of other members of the team. The selected candidate will be able to get to work in all weathers the site cannot operate without a QADSM.  A reasonable degree of physical fitness is required in order to climb gantries etc.

How to apply:

For more information or to apply for this QA & Development Shift Manager role please contact Victoria Walker on 0114 2839956 or email vwalker@ckscience.co.uk.  Please quote reference SH23694 in all correspondence.

                                                         Click here to apply online now!

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Dyson are to create 300 jobs after record turnover

As reported by BBC News, the British Engineering and Technology Company Dyson have announced the creation of 300 new jobs due to it hitting a £1billion turnover for the first time in the company’s twenty year history.

The company’s new chief executive, Max Conze, said 200 of the new jobs would be engineering positions and at least 150 will go to graduates. These new positions equate to eight per cent of the 3,600 staff Dyson employs worldwide.

The Wiltshire-based group, founded by Sir James Dyson in 1992  sells machines, including hand dryers, in more than 50 markets. It did not reveal its profit figure for the year. In 2010, the business made a profit of £210m on turnover of £887m.

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QC Scientist – Glasgow Area

Heather Deagle at CK Science is currently recruiting for a QC Scientist to join a pharmaceutical company at one of their sites in the Glasgow area.

Responsibilities:

As a QC Scientist you will have responsibility for performing analytical (chemistry and microbiology based) duties whilst adhering to related GMP, COSHH and Health & Safety regulations.

Working to GMP role involves:

  • scheduling of own workload
  • performing analysis in accordance with SOPs, ensuring analytical work (Release, In-Process, Raw Materials & Stability) is performed and reported within agreed timelines.
  • Overview and organisation of cleaning verification program.
  • Overview and organisation of reference standard material within the QC/Microbiology group.
  • Provision of Microbiology support to production group and clients such that ongoing compliance is maintained.
  • Ensuring correct receipt, labelling, storage and despatch of samples within the laboratory.
  • Review of testing results & reports from peers. I
  • Identifying OOS, OOT and system failures and reports to line management.
  • Contribution to drafting of departmental documentation – procedures, protocols, reports etc.
  • Assists with regulatory audits where appropriate.
  • Liaises with clients (internal and external) as appropriate.

Qualifications and skills:

The successful candidate for this QC Scientist role will have a degree or similar in an appropriate scientific discipline with demonstrable relevant industry experience in similar role.

How to apply:

For more information or to apply for this QC Scientist role please contact Heather Deagle on 01913848905 or email hdeagle@ckscience.co.uk.  Please quote reference DH23689 in all correspondence.

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Establishment of Development Centre in China

Takeda released a press statement today announcing the establishment of the Shanghai Development Center (“TSDC”) within the Shanghai-based Takeda (China) Holdings Co., Ltd. (“TCH”), which is a wholly owned subsidiary of Takeda.

This new drug development center in Shanghai is intended to complement the international clinical work now under way in Singapore and Cambridge, MA.

Both of the existing operations, including the cancer drug developer Millennium in Cambridge, work with contract research organizations to advance new treatments through the clinic. Now the Shanghai operation will draw on the international team to study new drugs catering to the fast-growing market in China.

The establishment of [the Takeda Shanghai Development Center] will provide a powerful addition to this global development infrastructure,” the company stated today. Through the resources of TSDC, Takeda will continue to conduct high quality clinical trials which will lead to secure regulatory approval in Asia, with a growing emphasis on China, and continue to build deeper relationships with physicians and regulatory authorities.”

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Senior Analytical Chemist – Northern Ireland

Naynesh Mistry at CK Science is looking for two Senior Analytical Chemists to join an API development and manufacturer based in Northern Ireland, to supervise their team of development analysts.

Responsibilities:

The main roles and responsibilities of these Senior Analytical Chemist roles will be to perform, monitor and accept accountability for all assigned analytical duties relating to specific analytical projects as well as to supervise, delegate and review analytical activities of reporting staff. You will be responsible for the technical development and mentoring of reporting staff and will develop and validate analytical methods in support of API Development and Plant Manufacture. These methods will be for key starting materials, isolated intermediates and the final API as well as in-process controls. You will also perform routine analytical testing in-line with project requirements and will be fully competent in the following analytical techniques, as dictatedbyproject and/or departmental requirements: HPLC, GC, NMR, IR, UV, MS, KF, Classical techniques. It will also be your responsibility to prepare and present analytical data to customers (telecoms, face-to-face meetings etc.).
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Qualifications and Skills:

In order to be considered for these Senior Analytical Chemist roles you will be degree qualified or equivalent in an analytical discipline. You will have previous analytical development experience in support of API Manufacturing within industry (i.e. pharmaceuticals or biotech) and will be fully proficient in (U)HPLC method development and ICH validation. With theoretical and hands-on experience of a wide range of analytical techniques required for characterising APIs (IR, NMR, MS, (U)HPLC, GC, GC-HS, LC-MS, GC-MS, IC, KF,ICP/AAS, XRPD etc.) you will have up-to-date knowledge of GMP and Regulatory requirements with respect to API development. You will be experienced in supervising and developing other analysts and technicians.

Please note that the closing date for this role is Friday 10th February 2012.
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How to apply:

For more information or to apply for these Senior Analytical Chemist roles please contact Naynesh Mistry on 0114 2839956 or email nmistry@ckscience.co.uk.  Please quote reference SH23643 in all correspondence.

                                                       Click here to apply online now

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Chief Operating Officer (Diagnostics) – Wiltshire

Andrew Bolton at CK Science is currently looking for a Chief Operating Officer to join an international medical device organisation, specialising in the development & manufacturing of industry changing molecular diagnostic technology to be based from their site in Wiltshire.

Responsibilities:

As the Chief Operating Officer (COO), you will be responsible for planning, developing & implementing strategies across operational management & development including management of internal operations encompassing commercial manufacturers, supply chain, logistics, materials management & technical support to customers.

Your duties will include:

  • A key member of the Executive Leadership Team liaising with other Directors & Managers, coupled with leading, managing & developing Operations Team.
  • Lead, drive and manage the development and evaluation of the Company operational strategy and performance.
  • Establish and maintain appropriate systems for measuring necessary aspects of operational management and development.
  • Monitor, measure and report on operational issues, opportunities, development plans and achievements within agreed formats and timescales.
  • Maintain awareness & knowledge of operational best practice to achieve company goals.
  • Represent the company at meetings with external parties, customers & at industry events / conferences.

This is an outstanding opportunity to join a growing Diagnostic organisation, which in return offers a negotiable salary & benefits package.

Qualifications and Skills:

To be considered for this Chief Operating Officer role, the successful candidate will have a Degree / PhD in a Life Science or Engineering discipline (or equivalent) and:

  • Proven track record of growing R&D / Medical Device companies.
  • Working knowledge of the Medical Device and/or Diagnostic industries.
  • Extensive experience of developing & implementing operational strategies (e.g. Manufacturing, Supply Chain, Logistics).
  • Demonstrated commercial experience.

How to apply:

For more information or to apply for this Chief Operating Officer role please contact Andrew Bolton on 01438 723 500 or email abolton@ckscience.co.uk. Please quote reference ST23651 in all correspondence.

                                                         Click here to apply now!

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A new state-of-the art microscope will revolutionise the detection of cancer in Scotland

The Scotsman.com has reported that a NEW state-of-the art microscope is currently under construction at the Edinburgh Cancer Research UK Centre at the city’s Western General Hospital. This new microscope will revolutionise the detection and treatment of cancer in Scotland by giving scientists the ability to track rogue cells as they move around the body.

This £400,000 microscope, one of only two in the world (the other one is at Harvard University in Cambridge, Massachusetts)  uses “vibrational” images to allow researchers to see deep into active cancer cells, giving a unique view of how the disease spreads.  Most cancer deaths are caused when diseased cells migrate within the body – a process called metastasis – and develop as secondary tumours. The new equipment will help researchers establish if a cancer has spread, and whether drugs might prevent this.

 Dr Alan Serrels who is a Cancer Research UK scientist is building the microscope with colleague Andy Downes from the School of Engineering at the University of Edinburgh.  Serrels said: “This microscope allows researchers to see what’s going on deep within living tissue. By spying on the inner workings of cells in this way, it will reveal clues as to how cancers grow and spread, as well as allowing scientists to directly witness the effects of treatments on tumours. The work will significantly improve our understanding of metastasis and reveal opportunities to develop new treatments to stop cancer in its tracks.”

It is hoped the technology will eventually lead to the development of new treatments to stop the disease spreading.

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Analytical Chemist – Northern Ireland

Naynesh Mistry is looking to recruit 2 x Analytical Chemists to join an international pharmaceutical organisation to work at their site in Northern Ireland on a permanent basis.

Responsibilities:

The main aspects of these Analytical Chemists roles is to perform, monitor and accept accountability for all assigned analytical duties relating to specific chemistry and/or analytical projects.  The post holder will hold the following responsibilities:

  • Develop and suitably validate analytical methods in support of API development and manufacturing.
  • Perform routine analytical testing in-line with project requirements.
  • Be trained and be fully competent in the following analytical techniques, as dictated by project and/or departmental requirements: HPLC, GC, NMR, IR, UV, MS, KF, Classical techniques
  • Perform analytical duties right-first-time in order to complete work within the budgeted resource time and in line with agreed timelines.
  • Prepare, review and approve data and documents accurately and efficiently, in-line with the Analytical Department’s procedures culture of Right-First-Time.
  • Take responsibility for the provision of all analytical activities associated with allocated projects so as to ensure successful project outcomes as measured by QQTE (Quantity, Quality, Timeliness & Efficiency) metrics.
  • Be responsible for the generation, training and adherence to of analytical documents (e.g. methods, specifications, SOPs etc).
  • Allocate work to and supervise analytical chemists/technicians/placement students.
  • Retain the overall responsibility for the completion of delegated tasks, within agreed budgets and timelines.
  • Retain an up to date knowledge of analytical techniques and equipment.
  • Be responsible for the management of own work schedule and provide regular updates to line manager and team members especially with respect to any circumstances that alter agreed timescales and budgets.
  • Ensure that unplanned deviations (UPDs) are kept to a minimum and that your line manager is notified as soon as UPDs are generated.
  • Assist with the identification of alternative test methods and/or equipment to improve efficiency and maximise throughput of testing in the laboratories.
  • Make suggestions for the improvement of efficiency and/or reduction in operating costs within the Analytical Department and the wider company.
  • Identify incidents of out of specification results and inform the Analytical Team Leader and/or Analytical Manager.
  • Assist in the generation of specifications and SOPs relevant to the Analytical Laboratories, ensuring that current versions are available.
  • Deputise for their supervisor’s absence in the day-to-day running of projects and supervision of analytical activities being performed in their designated laboratory.

Qualifications and skills:

The ideal candidates for these Analytical Chemist roles should have a degree in Life Sciences or equivalent.  It is also essential that they have:

  • Previous analytical experience within industry (i.e. pharmaceuticals/fine chemistry)
  • Experience of drug substance or drug product analysis in a GMP/GLP environment
  • Experience in HPLC method development and/or validation
  • Experience in cGMP audits and knowledge of Microsoft Office (Word, Office, Excel etc)

How to apply

For more information or to apply for these Analytical Chemists roles please contact Naynesh Mistry on 0114 2839956 or email nmistry@ckscience.co.uk.  Please quote reference SH23645 in all correspondence.

                                                        Click here to apply online now!

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Pfizer Kent staff find jobs after made redundant

BBC News reported that  two-thirds of the workers who left the Pfizer site in Kent after being made redundant last year have found other jobs. This comes after the company unfortunately last year had to close some of its Kent based site which employed 2400 people.  Pfizer said that it would keep 650 jobs in Kent and 250 at other UK sites. Speaking about the workers who had found work elsewhere, Dr Annette Doherty, site leader for Pfizer Sandwich, said some workers remained in the biomedical sector while others had left Kent and moved to other roles.

Pfizer said it had tried to monitor the impact of the closure announcement on colleagues and based on the voluntary responses of more than 1,000 people leaving the company had estimated that about two-thirds had left for new opportunities.

It also was reported last week that Pfizer was in detailed talks with a consortium led by London and Metropolitan about buying the site. Dr Doherty said that if the sale went ahead, London and Metropolitan would become the site owner and would rent space to other companies. Pfizer would remain, running a smaller operation in rented buildings, and three other science and technology companies were also moving in.

Laura Sandys, Conservative MP for South Thanet and Sandwich, said: “While there are still staff who have not found jobs and companies in the area who were reliant on Pfizer, almost 1,000 jobs are now secure and a new buyer for the site is in final negotiations. What seemed like a disastrous day a year ago looks a lot more promising.”

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Quality Assurance Representative – North West

Hannah Milward is currently recruiting for a Quality Assurance Representative to join a global manufacturer of pharmaceutical and veterinary medicine products based in the Merseyside region. They require a Contract Quality Assurance Representative to join their team for an initial period of 12 months.

Job Purpose:

The successful candidate for this Quality Assurance Representative will provide the Quality Assurance Team the assurance that manufacturing is carried out in accordance with cGMP and Regulatory commitments and that production records provide full and accurate documentation of batch manufacture in accordance with SOP. The QAR is authorised, as appropriate, by the QA Team Leader to disposition materials with consideration being given to the Regulatory requirement for QP release of veterinary and medicinal products. The job holder also exercises control on the general cGMP activities for those teams he/she has QA responsibility for.

Responsibilities:

The responsibilities of this Quality Assurance Representative role will include:

• Disposition raw materials, including packaging items, water, intermediates and products according to the available data, including evaluation of any deviation reports, environmental monitoring (where appropriate), and advise on reprocessing or preventive actions in such cases.

• Monitor trends and identify problems in quality of purchased materials, packaging, intermediates, products, water and environmental data and promote action having regard to changes in processes, facilities, equipment and procedures.

• Write/revise/approve and give advise on quality documentation e.g. batch production records, specifications, procedures (Team and Site), PMISsheets, Stability protocols.

• Review and approve SOPs (Team and Site), change control documentation, validation protocols, completed validation packages, IQ/OQ/PQ protocols.

• Manage the Site stability programme to meet Corporate and Regulatory requirements.

• To advise on the investigation of customer complaints, approve customer complaint reports and promote corrective/preventive actions

• Participate in self-inspections and other audits of the manufacturing and relevant Support areas with particular reference to cGMP as defined by the various regulatory authorities.

• Provide training, support, advice and proactive assistance in the Site Quality systems to the product and support teams.

• Advise on and support appropriate validation of plant, processes and new projects, liaising with other disciplines appropriately to ensure that facilities are designed and commissioned to meet cGMP.

• Provide cover for other QARs in their absence.

• Prepare Quality Agreements as appropriate.

• Liaise with Contract Manufacturers, as appropriate, to ensure that the Quality systems at the Contract Manufacturers comply with Corporate/Regulatory requirements and that the Quality systems are being implemented appropriately.

Qualifications and skills:

To be considered for this Quality Assurance Representative position you will have experience working in a similar role reviewing and supplying batch record documentation to the QP for release. You will also have experience working in the Pharmaceutical industry.

How to apply:

For more information or to apply for this Quality Assurance Representative role please contact Hannah Milward on 0114 2839956 or email hmilward@ckscience.co.uk. Please quote reference SH23570 in all correspondence.

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Toxicologist (Chemical) – Oxfordshire

Andrew Bolton at CK Science is currently looking for a Toxicologist to join a world leading Chemical Manufacturer, who specialises in chemicals for the industrial, automotive & related markets. They are currently looking for a Toxicologist to join their Regulatory Team based from their state-of-the-art facilities in Oxfordshire.

The job:

This Toxicologist role is an outstanding opportunity to join a Chemical Manufacturer at the forefront of their field. The organisation is willing to consider candidate’s at various levels, offering in return a negotiable salary depending on experience and excellent benefits.

Responsibilities:

As a Toxicologist, you will be part of a team providing toxicology & regulatory support to new & existing product development teams worldwide. Your duties will include:

  • Performing risk & hazard assessments for the organisation’s product ranges to ensure they are used & manufactured appropriately including providing toxicology support to R&D teams
  • Assessing toxicology &/or ecotoxicology studies and preparing regulatory dossiers
  • Liaising with external test laboratories surrounding studies into regulatory notification schemes such as REACH as well as maintaining the toxicology databases on all substances within the organisation’s portfolio.

Qualifications:

To be considered for this Toxicologist role, you will have demonstrated experience within a Toxicologist position gained within a Chemical industry. Working knowledge of REACH would be advantageous, but it is not essential.

How to apply:

For more information or to apply for this Toxicologist role please contact Andrew Bolton on 01438 723 500 or email abolton@ckscience.co.uk. Please quote reference ST23552 in all correspondence.

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Product Development Chemist – Scotland

Barney Smith at CK Science is recruiting for a Product development Chemist to join a company that manufactures novel products for the Oil & Gas industry

Responsibilities:

As a Product development Chemist you will be responsible for developing rubber based polymers to customer specifications and requirements.  This will include developing polymers from scratch, developing existing products, compounding, sourcing and maintaining test equipment and providing technical support to clients. 

Qualifications and Skills:

The ideal candidate for this Product development Chemist must be qualified to PhD in organic or polymer chemistry standard or possess equivalent commercial laboratory experience within rubber or plastics development.  They must also possess working knowledge of instrumentation and equipment used in rubber development and compounding and your communication skills must be excellent.

How to apply:

For more information or to apply for this Product development Chemist role please contact Barney Smith on 0191 384 8905 or email bsmith@ckscience.co.uk. Please quote reference DH23591 in all correspondence.

                                                         Click here to apply online!

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QA Specialist (Temp) – Northern Scotland

Graeme Pallas at CK Science is currently recruiting for two QA Specialists to join a multi national pharmaceutical company to work with them on initially a temporary contract until the end of 2012.

Responsibilities:

The successful candidate for this QA Specialist role will be responsible for driving a quality culture throughout site ensuring that products and services meet the necessary regulatory requirements.  In addition, you will support the maintenance and operation of the quality system including change control, deviations and CAPA.  You may also participate in both internal and external audit programmes.

Qualifications:

As a QA Specialist you will be qualified in a life sciences subject and or/or have demonstrable experience working in the quality assurance function of a manufacturing organisation.

How to apply:

For more information or to apply for this QA Specialist role please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk. Please quote reference DH23588in all correspondence.

                                                       Click here to apply online now!

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Almac achieves success in their MHRA Audits

Pharmiweb has reported that Almac has achieved success in MHRA inspections at both their Craigavon Headquarters, Northern Ireland and Elvingston, Scotland sites. These inspections were the first biennial audits to confirm continued compliance with Investigation Medicinal Products (IMP) licenses and GMP certificates.

The first inspection audited Almac’s isotope laboratory facility in support of their IMP license. Following the MHRA’s acceptance of Almac’s response report, Almac’s licence will be applicable to both radiolabelled and non-labelled IMPs. The second inspection covered Almac’s analytical laboratory in Elvingston, Scotland, supporting its GMP certificate as a contract analytical facility.

The Inspector complimented the analytical team on their professionalism and laboratory high standards. As a result of this successful audit, two GMP certificates will be issued for human and veterinary applications.

President and Managing Director, Stephen Barr commented on the successful audits saying:
“We are delighted with the outcome of these inspections. It is reassuring to know that the value we place on our staff and facilities is recognised in this way, and adds further credibility to our wealth of experience and services we offer.”

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Process Improvement Manager – East Midland

Hannah Milward is currently seeking to recruit a Process Improvement Manager to join a major healthcare organisation.

The job: 

As a Process Improvement Manager you will provide focus on the development of new and existing processes. By building quality in to the process design, the products will be produced in the most efficient way and meet the customer and regulatory needs.

Responsibilities:

As a Process Improvement Manager you will be responsible for leading the Process Improvement Team to provide an efficient service to optimise manufacturing and cleaning processes using a quality by design approach whilst ensuring the validation activities meet Regulatory and Customer requirements.

The job holder will need to provide an effective New Product Introduction service for Clinical Trial clients to ensure new products are introduced successfully and that the processes are developed and validated to ensure the required levels of product quality and regulatory compliance are met. You will also need to deliver a comprehensive process, equipment and cleaning validation programme in accordance with cGMP and Customer requirements.

Qualifications and skills:

To be considered for this Process Improvement Manager position you will have:

  • Previous experience in the development or manufacture of healthcare products with a proven track record of new product introduction which is critical to this role.
  • In depth knowledge of cGMP, multiple dosage forms with an emphasis on sterile products and an awareness of Unlicensed and Licensed Legislation are key to your success in this role.
  • Previous leadership and management skills would be an advantage.

You will also enjoy working cross functionally in a fast paced environment with teams of diverse people, have a can do attitude with the capability to plan and see the bigger picture, excellent Leadership and Customer Service skills and the ability to influence and build relationships at all levels across the business.

How to apply:

For more information or to apply for this role please contact Hannah Milward on 0114 283 9956 or email hmilward@ckscience.co.uk. Please quote reference SH23326 in all correspondence.

                                                    Click here to apply online now!

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Quality Assurance Auditor Job (Pharmaceuticals) – Hertfordshire

Reena Dhana at CK Science is recruiting for a Quality Assurance Auditor to join a global pharmaceutical company to be based within the GMP Quality Department based in Hertfordshire.  This is initially a temporary contract of 4 months with a strong possibility of extension.

Responsibilities:

As a Quality Assurance Auditor you will ensure compliance to cGMP of all activities related to the development of pharmaceutical products for use in Clinical Trials, including the Quality Management systems and you will carry out Quality compliance reviews/release of Investigational Medicinal Products for use in Clinical Trials. Other duties will include auditing and approving procedures and documents from manufacturing, analytical, packaging and service groups, reviewing and approving equipment and facilities qualification, training others as appropriate and assisting with external audits as required.

Qualification and Skills:

The ideal candidate for this Quality Assurance Auditor role will hold a BSc in a Life Science subject (or equivalent) and will have experience gained within relevant departments of Pharmaceutical companies, preferably Quality Assurance. You will have a good working knowledge of cGMPs. An understanding of Clinical Supplies requirements would be advantageous.

How to apply:

For more information or to apply for this Quality Assurance Auditor role please contact Reena Dhana on 01438 723 500 or email rdhana@ckscience.co.uk.  Please quote reference DH23538 in all correspondence.

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