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Study Director - LCMS/MS

Employer
Labcorp
Location
Huntingdon, United Kingdom
Salary
Competitive
Start date
24 Oct 2021
Closing date
29 Oct 2021

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Discipline
Medical Affairs, Scientific Advisor
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


Are you looking for your next opportunity in Bioanalysis (LC-MS/MS) Study Management?

Do you want to be the pivotal point between our clients and the scientists?

Do you want to work for a world class leading company who work together to build a healthier and Safer world?

Labcorp Drug Development, a global contract research organization, have worked on all of the top 50 best-selling drugs available today through its full spectrum of nonclinical, clinical and commercialization services with our clients from leading pharma and agile biotech. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow's challenges as they evolve.

We are looking to appoint a Study Directorwho will be responsible for the management of bioanalytical (LC-MS/MS) studies/phases of studies ensuring that all work is conducted in accordance with the Study Plan, SOPs and appropriate regulatory standards such as GLP & GCP, and guidelines (EMA and FDA Bioanalytical Method Validation, SANCO etc.). The role will be based at our site in Huntingdon, Cambridgeshire.

Your responsibilities:
  • Undertaking study/laboratory related activities and record keeping
  • Supporting our radiochemists in re-purifications, the setting up of chemical reactions, plus monitoring of synthesis reactions and work-up of these reactions, using analytical techniques of HPLC, TLC and LC-MS where appropriate with training and guidance
  • Gaining experience in the skills required to conduct technical and scientific procedures
  • Leading in general laboratory and radiosynthesis specific housekeeping
  • Ensuring that all work is conducted in accordance with study plans and company SOPs
  • Maintaining compliance with GLP and HSE regulations at all times
  • Providing timely updates of study progress to the Study Director and ensuring that the Study Director is informed of any problems that may require review or may compromise study integrity
  • Correct use of on-line data capture systems and office computers
  • Reviewing own work for overall accuracy, timeliness, completeness, and soundness of technical judgment
  • Delivering results within agreed timeframe, whilst recognizing changes in priorities
  • Routinely supporting studies in non-primary area of work
  • Performing other related duties as assigned
  • Following instructions, SOPs and study plans/protocols that apply to current role to complete assigned tasks and projects
  • Consistently and continuously responds efficiently to requests (delivers high quality output on time)
  • Being able to establish clear plans to meet short and medium term requirements for projects
  • Being able to anticipate issues/obstacles which may prevent meeting project/department objectives and identify solutions to overcome difficulties
  • Being able to recognize deviations from normal results and inform Study Director, Study Coordinator (as applicable) and/or management of any problems that may affect integrity of the data
  • Recommending modifications to routine procedures to adapt to problems in primary area
  • Being able to understand the scope of a study (primary area of work) and complete with minimal supervision

We offer:
  • A competitive salary together with a comprehensive benefits package including health cover and pension
  • Unsurpassed career development opportunities supported by exceptional people from across the globe with an energized purpose
  • Ability to work with a variety of different, global clients on wide ranging projects

If you want to be part of a team that helps to bring the miracles of medicine to the market sooner then please apply now.
Education/Qualifications:
  • BSc (eg. Chemistry or Biochemistry) minimum with extensive direct industry experience
Experience:
  • Proven experience of working in Bioanalysis LC-MS/MS within a CRO/pharmaceutical environment as a bioanalytical study manager/study director or equivalent
  • Highly skilled in conducting research, data interpretation and writing reports
  • Proven record of accomplishment of managing regulated bioanalytical preclinical and clinical studies
  • Client facing experience is desirable
  • Experience and knowledge of analytical instrumentation (LC/MS/MS) and its application in bioanalysis
  • Highly skilled in performing scientific presentation and preparing scientific publications
  • Knowledge of laboratory automation, scientific system software, LIMS, and Microsoft applications
  • Effective oral and written communication skills along with great organisational skills
  • Has worked within a GLP/GCP environment

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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