Study Manager opportunities in ADME and E-Fate

Recruiter
Pharmaron UK
Location
West Midlands Region
Salary
Competitive
Posted
23 Apr 2018
Closes
19 May 2018
Job Type
Manager
Contract Type
Permanent

Pharmaron is a premier R&D service provider for the pharmaceutical industry. Founded in 2003, Pharmaron has invested in its people and facilities, and established a broad spectrum of drug R&D service capabilities, ranging from synthetic and medicinal chemistry, biology, DMPK, pharmacology, safety assessment, radiochemistry and radiolabelled metabolism to chemical & pharmaceutical development. With about 4,000 employees and operations in China, the U.S. and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

The Rushden site is the a centre of excellence for Radiolabelled Sciences incorporating both Metabolism (which includes Clinical Metabolism, Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate and Plant Metabolism and Metabolite Identification) and Chemistry (which includes API and IMP manufacture).

Due to recent expansion Pharmaron are currently looking to recruit Study Managers in ADME and E-Fate at their Rushden facility.

Job Specification

  • Conduct and/or Study Direct metabolism studies in either ADME or E-Fate for new product development based on global regulatory requirements.
  • Act as Study Director, Analytical Project Manager and/or Principal Investigator on metabolism studies.
  • Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
  • Plan work to ensure revenue recognition milestones on assigned studies are hit in the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilised.
  • Prepare study plans, amendments, file notes and deviations as required.
  • Prepare worksheets to coordinate experimental activities.
  • Calculate and QC check data.
  • Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports.
  • Prepare study reports.
  • Address findings arising from QA audits and process inspections.
  • Comply at all times with health & Safety legislation and Company Safety Policyies.
  • Comply with Good Laboratory Practice, Good Clinical Practice and/ or Good Manufacturing Practice requirements whenever appropriate to the work being undertaken.

Essential requirements

  • PHD or Bsc in a life science subject
  • Previous experience of conducting Metabolism studies in either ADME or E-Fate in a GLP environment.
  • Experience of Study Directing Metabolism studies in the pharmaceutical or CRO industry is desirable
  • Experience of working with large molecules is desirable
  • Good written and verbal communication skills
  • Computer literate
  • Ability to work with minimum supervision and as part of a team
  • Good time management skills and ability to work to tight deadlines
  • Proven ability to problem solve
  • Willing to get involved with new ideas and initiatives

The position is full time and permanent. Hours of work are 37.5 per week Monday - Friday. Annual holiday entitlement is 23 days a year plus Bank Holidays. The company operates a contributory pension scheme, life assurance and a flexible benefits package.

To apply please send a CV and a covering letter via "Apply" button quoting: Metabolism-Study Manager - stating either ADME or E-FATE preference