Study Manager - ADME
Salary: Competitive Salary
Ref: ALS 2039
Our client, a premier R&D provider for the pharmaceutical industry, are looking to recruit an experienced Study Manager to work within their Biologics department at a centre of excellence for Radiolabelled Sciences based in Northamptonshire.
Our client have 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.
- PhD or BSc in a life science subject
- Previous experience of conducting Metabolism/ADME studies in a GLP environment
- Experience of Study Directing Metabolism studies in the pharmaceutical or CRO industry Experience of working with large molecules is desirable
- HPLC and Chromatography experience
- Dose formulation experience
- Ability to work with minimum supervision and as part of a team
- Good time management skills and ability to work to tight deadlines
- Willing to get involved with new ideas and initiatives.
Duties & Responsibilities:
- Conduct and/or Study Direct metabolism studies 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 and reports, 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
- Address findings arising from QA audits and process inspections
- Comply at all times with Health & Safety legislation and Company Safety Policies
- Comply with Good Laboratory Practice, Good Clinical Practice and/or Good Manufacturing Practice requirements whenever appropriate to the work being undertaken.
Agenda and its clients only recruit people who are passionate about animal care and welfare, people with integrity who are honest and trustworthy and who have a great work ethic. To enable us to hire the very best people we will conduct a full and comprehensive background and pre-employment screening as an essential part of the recruitment process.