GSK & Theravance receive positive data for pill

PharmaTimes have reported that GlaxoSmithKline and Theravance have reported positive data from four Phase III trials assessing a combination therapy for maintenance treatment of COPD, making the once-daily pill closer to a regulatory filing.

The clinical trials involved more than 4,000 patients, including two 24-week efficacy trials comparing a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide and the long-acting beta-agonist (LABA) vilanterol. The date showed statistically significant improvements when compared with placebo and the individual parts in both trials, which tested difference doses.

Darrell Baker, SVP Respiratory Portfolio Optimisation Leader at GSK said “We are very encouraged by the results of these initial studies for our LAMA/LABA, an important cornerstone of our broad respiratory development portfolio…. These studies, together with our earlier dose-ranging work, give us confidence that this is a once-daily medicine with the potential to benefit many patients with COPD.

 

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Quintiles to Create UK Jobs

Biopharmaceutical company Quintiles is looking to establish more UK sites, creating pharmaceutical and clinical jobs, reports pharmatimes.com.

The US company sees the UK as a good place for clinical trials and is hoping to open at least two more Prime Sites to go alongside the one at Queen Mary, University of London. Including two other current sites, Quintiles employs 2,000 people in the UK, a figure set to rise with the planned opening of the new Prime Sites.

Lindy Jones, Quintiles head of global integrated site services, says the UK is of “significant interested to us,” with fifty trials currently being run at the Queen Mary site. Jones believe that the UK “has opened up far more to clinical research” in the past eighteen months, meaning that Quintiles is considering opening “an additional two, maybe three Prime Sites in the UK.”

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Qualified Person Job (QP) – South East, UK

CK Science is currently searching for a Qualified Person (QP) to join our client, a company which provides Clinical Trial services including import, secondary packaging, batch release and distribution of Advance Therapy Medicinal Products and other specialised IMPs.

This QP role is a 12 month fixed term contract that is a full time position but there maybe the possibility to work part time for the right candidate.

 

Key Responsibilities

The key responsibilities of this QP position will include:

  • To provide QP certification/release as required by technical agreements with clients.
  • To conduct internal and external audits.
  • To act as the primary contact point for Quality for major clients.
  • To maintain an up-to-date awareness of current legislation and contribute to QP politics.
  • To provide technical advice and support in the preparation of Technical Agreements to the Contracts and Proposals group.
  • To provide GMP training.

 

Skills and Experience:

The ideal candidate for this QP role will have the following skills and experience:

  • Pharmaceutical development experience
  • Experience in the management of Clinical Supplies
  • Knowledge of the regulatory processes for clinical trials.

 

Apply Now

For more information, or to apply for this QP position, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST20740 in all correspondence.

 

Alternatively, click here to apply for this QP job online now.

 

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Eli Lilly to Cut Pharmaceutical Science Jobs

Pharmaceutical Science Job CutsPharmaceutical giant Eli Lilly has signed a new five-year agreement with Thermo Fisher Scientific which could cut pharmaceutical jobs in America.

As part of the deal, by summer 2010 the Fisher Clinical Services business of Thermo Fisher will be taking responsibility for Eli Lilly’s in-house clinical trial materials manufacturing, packaging and labelling operations. Not only this, but by the end of 2010, Fisher Clinical Services will handle the distribution of clinical trial materials for Lilly throughout North America.

Speaking of the move, Ralph Lipp, PhD, Vice President of Pharmaceutical Sciences Research and Development for Lilly, said, “Transitioning work like the manufacturing, packaging and labeling of clinical trial materials to Fisher Clinical Services helps us also reach Lilly’s corporate goals of reducing the costs of drug development and speeding innovative medicines to patients.”

As a result of this agreement, Lily is to cut approximately 115 pharmaceutical jobs from it’s workforce. Those employees effected will be given the opportunity to apply for pharmaceutical jobs with Fisher Clinical Services.

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Clinical Laboratory Supervisor – Cambridge, UK

Our client, a dynamic, highly specialised, and rapidly growing clinical laboratory, are currently looking for a Clinical Laboratory Supervisor to join their team based in Cambridge. The laboratory provides sample accessioning and laboratory testing in support of the company’s commercial testing programs.

Reporting to the Lab Manager based in the U.S, the Laboratory Supervisor will supervise a team that is responsible for sample accessioning and antibody testing within the Clinical Specialty Laboratory of their Clinical Lab Science group at the site in Cambridge.

Key responsibilities of this Laboratory Supervisor role will include entering sample data from commercial registry programs and clinical trial programs in a specialised laboratory information system, supervising analytical testing for clinical studies and the monitoring lab efficiencies and quality as they relate to sample receipt, database entry, and reagent inventory.

The ideal candidate will hold an MSc or a degree in medical laboratory science (or equivalent) with in-depth experience of working in a clinical laboratory. They will also be registered with the Health Professions Council (or will have equivalent registration or certification). Proven experience of working in a clinical laboratory including working with a laboratory information database and knowledge in laboratory regulatory standards, accessioning, immunoassay and ELISA testing, as well as laboratory information medical systems are essential

If you would like to hear more about this Clinical Laboratory Supervisor job, please contact Jason Johal on 01438 723 500 or email  jjohal@ckscience.co.uk.

Apply for this Clinical Laboratory Supervisor job online now.

If you are successful after the first round of screening we will contact you within 5 working days. Entitlement to work in the EEA is essential. Please quote reference ST19118 in all correspondence.

About CK Science

CK Science is the largest independent scientific recruitment company in the UK. Our team of specialist recruiters  are here to help you achieve your career ambitions within the scientific industry. We actively offer you careers advice; help with writing your CV, assistance with interview preparation and up-to-date information about the industry. We pride ourselves on providing an honest, straight-forward and trustworthy service to both our clients and candidates.

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Global QA Director based in South East, UK

An exciting Global QA Director job has arisen at an international Pharmaceutical company based in the South East of England. This is a Senior Leadership role for Quality Assurance serving both the external client and internal QA Departments.As an experienced Quality Assurance Director, you will act as the primary contact for all client-related QA communication, and the development and implementation of Quality Agreements. Further responsibilities of the role will include:

– Overseeing all quality-related concerns.

– Functioning as a liaison between a single, large-market clients and internal personnel.

– Developing and maintaining strong relationships with client QA senior management.

– Managing the single client’s quality and regulatory matters, CGMP compliance and two-way communication.

– Assuring that client requirements are developed, documented and agreed upon for manufacturing, testing and distribution and return of pharmaceutical clinical supplies.

This QA Director role will encompass all of my clients’ global locations and will interact with personnel in multiple client locations.

The ideal candidate will have extensive managerial QA/regulatory compliance experience in the pharmaceutical, chemical, medical device or biotech industry, as well as strong leadership experience in the field. You will also have an outstanding customer-service orientated background.

This is a rare opportunity for you to make your mark on a prestigious international pharmaceutical company. If you are interested in hearing more about this exciting role, please contact Jason Johal on 01438 723500 or email jjohal@ckscience.co.uk. Alternatively, you can meet Jason and hear more about this role at our YouTube Channel. To apply, click here.

CK Science is the leading independent scientific recruitment agency for science jobs. CK Science provide an all round recruitment service to the chemical, pharmaceutical, biotechnology, waste and environmental and other related industries right across the UK.

We have built a strong client base who appreciate our professionalism, integrity and commitment to finding the right person for the job. Equally important to our success are our candidates, who recognise our dedication to operating in a fair and ethical manner to meet their needs in the current job market.

Keywords: QA jobs, quality assurance jobs, pharmaceutical QA, clinical QA, QA Director, clinical trials, ck science, lab jobs, chemistry jobs, scientist jobs, science jobs, microbiology jobs, biology jobs, analytical jobs, scientific recruitment, biotechnology jobs

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