Scientist – Regulatory Bioanalysis – Integrated Discovery & Development Services

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Concept Life Sciences

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

A full time permanent opportunity is available on the Dundee site.   The Scientist position is an important role within the Analytical Sciences Team and will be focussed on supporting regulatory (GLP/GCP) bioanalysis.  It is envisaged that the success incumbent will be primarily responsible for the bioanalysis of samples generated from in vivo studies, however flexible support of non-regulatory in vivo and in vitro studies may be required. Reporting to the Team Leader of Regulatory Bioanalysis and working closely with Quality Assurance, the role ensures that work is executed to the highest scientific and regulatory standards.   The successful incumbent will also be expected to work with the wider site and organisation to ensure that all studies can be delivered to the same exacting standards and within agreed timelines.

Main Duties to:

  • Support the analysis of regulatory bioanalytical studies using LC-MS, LC-MS/MS, GC-MS, HPLC and GC techniques.
  • Support the analysis of regulatory formulation stability studies using LC-MS, LC-MS/MS, GC-MS, HPLC and GC techniques.
  • When required, assist in the Study analysis of all bioanalytical and DMPK studies (regulatory and non-regulatory) performed within the Dundee site.
  • When trained act as Study Director, Principal Investigator or Analytical Phase Manager (where appropriate) for regulatory studies (Bioanalysis and Formulation analysis).
  • Assist the Senior Scientist (Method Development) in the development and validation of chromatographic methods (LC-MS, LC-MS/MS, GC-MS, HPLC and GC) for bioanalytical support of GLP/GCP studies to current regulatory (FDA/EMEA) standards.
  • Assist the Senior Scientist (Method Development) in the development and validation of chromatographic methods (LC-MS, LC-MS/MS, GC-MS, HPLC and GC) for formulation analysis to current regulatory (FDA/EMEA) standards.
  • Contribute to scientific publications.
  • Operate in line with the company protocols and business strategy.
  • Contribute to authoring and review of SOPs and other business process documents.
  • Act as an ambassador for the business and in doing so proactively promoting the company brand and values both internally and externally.
  • Comply with health and safety requirements of the site as stated within company policy, procedure and practice.
  • Communicating effectively with colleagues throughout the business to share resources, technical knowledge and generally support all forms of business activity.
  • Contribute to a culture of collaboration and team work.
  • When required assist the Team Leader of Regulatory Bioanalysis and the Laboratory Manager in organising all repairs, maintenance of laboratory equipment and facilities.

Qualifications/Role Requirements:

  • Bachelor’s degree in chemistry (or related discipline) essential.
  • Higher degree (Master or Doctorate) in related discipline advantageous but not essential.
  • Knowledge and experience of chromatographic and mass spectrometric techniques essential.
  • Experience with Sciex equipment and Analyst software highly advantageous.
  • Experience of supporting bioanalytical studies within regulatory (GLP/GCP) framework essential.
  • Knowledge of alternative technologies such as ELISA highly advantageous.
  • Knowledge of in vitro DMPK assays highly advantageous.
  • Knowledge of market conditions, opportunities and competition desirable.
  • Understanding of customer base and commercial awareness also desirable.
  • High-level interpersonal skills.
  • Robust time management capability.

Working Hours

  • 37.5 hours per week with flexibility required to meet the needs of the business.

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, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.

To find out more and apply, please click here.