Study Director

Study Director

TITLE: GLP Study Director

REPORTS TO: Steven Woolley, Site Operations Director

LOCATION: Unit 69, Listerhills Science Park, Campus Road, Bradford, West Yorkshire BD7 1HR.

The Company

Concept Life Sciences, a Malvern Panalytical brand is a knowledge based, science led business focused on delivering the services, expertise and capabilities our clients require. Our business is focused on a number of core sectors including pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products industries. We support drug research, discovery and development to our 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. Concept currently employs over 250 employees across 5 main sites and is part of the Spectris Group. www.spectris.com.

The Role

The role of GLP Study Director at Concept Life Sciences Bradford 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 and would be an advantage but is not essential. 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, both at Bradford and at Concept Life Sciences’ other GLP accredited sites. In particular, good project management skills and organisation are key to this role.

The Bradford site operates to regulatory Good Laboratory Practice, and also current Good Manufacturing Practice, and is MHRA accredited.

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.

Qualifications/Role Requirements:

• BSc or higher in an analytical, chemical or related scientific field with demonstrated, relevant experience.
• Ideally, 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.
• Project management and organizational skills
• Proactive in your approach to your work.
• Role is subject to probation and training on internal processes.

Working Hours

• Full time (37.5hrs per week)

Company Benefits

We 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 our science based roles we offer structured career progression, more details of which can be discussed during the recruitment process. In addition to a competitive salary, we offer as a minimum: Pension scheme, Share Save scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, rates and local Reward & Recognition schemes.