GLP Study Director

Additional Resources Ltd
Bradford, UK
08 Jul 2019
30 Jul 2019
Contract Type
Full Time
GLP Study Director - Bradford

Salary - Circa £42k + Pension + Healthcare + Childcare Vouchers + Gym Membership

The Client

Our client is a knowledge based, science led business focused on delivering the services, expertise and capabilities to their clients. Their business is focused on a number of core sectors including pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products industries. They support drug research, discovery and development to their pharmaceutical and biotechnology clients; provide testing and specialist analytical services and consultancy to the pharmaceutical, food and environmental sectors, toxicology services to the pharmaceutical, chemical, agrochemical and consumer products industries and materials chemistry services to the petrochemical industry. The company currently employs over 800 employees across 11 main sites in the U.K.

The Role

The role of GLP Study Director involves performing or managing GLP analytical studies, which might include method development and validation phases plus test item analysis. A background in chromatography techniques, combined with experience of 5-batch analysis, ILV and GLP studies for the agrochemical, pesticides and biocides sector is of particular interest. Such studies may be applied to a wide range of test items (substances, compounds, formulations, investigational or commercial products, raw materials) submitted by sponsors.

Key to this role would be the planning, conduct and reporting of GLP study specific duties in an organised and timely manner, according to regulatory requirements and current Standard Operating Procedures (SOPs). The study director will co-ordinate a number of different studies at any one time, liaising with sponsors, ensuring GLP compliance, and authoring study plans and reports. In addition, the role holder will work closely with other study directors, across the companies GLP accredited sites.

Main Duties to:

Managing and delivering revenue generating laboratory-based GLP analytical studies, applying diverse techniques to a wide range of test items and study types.

Act as Study Director / Principal Scientist for studies / phases to which you are appointed.

Directing studies in accordance with Study Plan, SOPs and regulatory standards (GLP/cGMP).

Holding Study kick off meetings in line with company procedures.

Where applicable, peer review of data / reports generated by colleagues.

Providing high quality scientific studies to sponsors.

Ensuring adequate and timely response to audits.

Maintaining agreed schedules for the performance and reporting of studies.

Monitoring the transfer of all study data, test items and reports to the relevant archive at the conclusion of a study, in accordance with company standard procedures.

Developing new, and building on, existing client and customer relationships whilst promoting the services that the company can offer.

Contributing to and adhering to company standard operating procedures, with particular regard to regulatory GLP.

Skills and Experience

BSc or higher in an analytical, chemical or related scientific field with demonstrated, relevant experience.

Previous experience of GLP Study Director for regulatory (GLP) studies in an analytical setting is strongly preferred.

Experience of working in a regulated environment.

Excellent written and verbal communication skills.

Broad practical experience in developing and validating analytical methods.

Experienced in the use of complex analytical instrumentation and the interpretation of analytical data.

Familiarity with good scientific practice.

Demonstrated ability to take initiative, think and work independently, problem-solve, work in teams and multitask.

Able to identify and highlight own training needs, and proactively upskill.

A full, clean UK driving license.

Proactive in your approach to your work.

Role is subject to probation and training on internal processes.

The company offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard. In their science based roles they offer structured career progression, more details of which can be discussed during the recruitment process. In addition to a competitive salary, they offer as a minimum: Pension scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Additional Resources will be acting in your best interest and may contact you in rela

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