Concept Life Sciences is a knowledge based, science led business focused on delivering the expertise and capabilities our clients demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical and chemical; and consumer products sectors. Our business is home to Scientists with in-depth experience in their fields, who are enthusiastic about taking on challenges. We employ problem-solvers with a proven track record in life sciences, laboratory based analytical testing and specialist consulting.
The role of Study Director/Analytical Scientist at Concept Life Sciences Bradford involves performing or managing method development, validation and testing studies using a range of analytical techniques – principally, GC, LC and IC, with a wide range of detection techniques including MS and MS/MS. Such studies may be applied to a wide range of test items (substances, compounds, formulations, investigational or commercial products, raw materials) submitted by sponsors from the Life Sciences and broader chemical industries. Additionally, the planning, conduct and reporting of study specific duties in an organised and timely manner, according to regulatory requirements and current Standard Operating Procedures (SOPs).
The Bradford site operates to Good Laboratory Practice and also and current Good Manufacturing Practice, therefore proven experience of working in a similar role is essential. The GLP aspects of the role will involve co-ordinating a number of different studies at any one time, scheduling the study start, performing or managing the practical work required, ensuring GLP compliance, and preparing the study report.
Main Duties to:
- Revenue generating laboratory-based analytical studies, applying diverse techniques to a wide range of test item and study types.
- Analytical method development and validation, including drafting of related documents.
- 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.
- Peer review of data / reports generated by colleagues.
- Providing high quality scientific studies to sponsors.
- Ensuring studies comply with regulatory requirements.
- 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.
- Principle techniques dependent on experience and training.
- Contributing to and adhering to company standard operating procedures.
- 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).
- Broad practical experience in developing and validating analytical methods.
- Experienced in the use of complex analytical instrumentation.
- Experience of working in a regulated environment.
- Familiarity with good scientific practice.
- Excellent written and verbal communication skills.
- 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.
- Full time (37.5hrs per week).
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, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.