Extractable and Leachable (Trace Analysis) Scientist

Job description

Details:

GSK is a science-led global healthcare company with R&D playing a fundamental role in helping GSK to achieve its mission – enabling people to do more, feel better and live longer. The Analytical Sciences and Development (ASD) department, part of Product Development & Supply, undertakes critical expert work in supporting the drug development process as well as existing products, to deliver new medicines to patients by accelerating access to novel medicines, preventions and cures.

We now have a vacancy for a scientist with trace analysis expertise and knowledge of Extractable and Leachables (E&L) analysis to join GSK's Global Spectroscopy team within ASD. In this exciting role, you will have responsibility and accountability for the delivery of high quality data sets and the associated trace analytical methods, with which you will be expected to present key knowledge and understanding into regulatory submissions for a portfolio of small molecule, biopharmaceutical and/or cell & gene therapy projects supported within Analytical Sciences and Development. You will use your expertise in trace analysis and most especially your knowledge of detection and identification of leachables and their associated extractable studies, to effectively and efficiently reduce project risk and contribute to the control strategies for drug product.

If requiring an adjustment for a disability, once selected for
Interview you may contact ************@*******.**

Closing date for applications: 18th October 2016

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Desired profile

Basic qualifications:

• Bachelors or Masters degree in Chemistry or related disciplines with an extensive track record of relevant industry experience or Ph.D. in Chemistry or related disciplines with at significant relevant industry experience
• Proven technical leadership, communication and influencing skills
• Significant laboratory experience in trace level organic analysis as applied to leachables or other trace level impurities including the application of chromatography (LC and/or GC) coupled with mass spectrometry

Preferred qualifications:

• Knowledge and experience of the development of trace analysis method development, validation and technical transfer into CROs as part of pharmaceutical drug product development
• High level of problem solving capability
• Experience in conducting detailed risk assessments in the development of new products
• Understanding of control strategies as they apply to controls for leachables in either manufacturing systems or container closures for products
• Knowledge of relevant regulatory requirements in the field of extractables and leachables and/or genotoxins
• Knowledge in sample preparation techniques at the trace level
• Have the ability and skills to coach and mentor junior members of staff
• Have a working understanding of quality systems such as cGMP and/or GLP