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Study Manager - Quantitative Mass Spec - Regulated bioanalysis

Employer
NonStop Consulting
Location
Northamptonshire
Salary
£25000 - £45000 per annum
Closing date
Nov 9, 2018

View more

Sector
Science, Chemistry, General Chemistry
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Entry Level and Graduate

Job Details

Study Manager - Quantitative Mass Spec - Regulated bioanalysis

Acting as a provider to a number of sectors ranging from environmental to chemical, our client offers one of the most anticipated consultancies of 2018. Given a significant strategy overhaul and headcount investment, it promises a bright future for those joining new teams and taking on fresh new projects. The current recruitment strategy is creating an industry buzz which could contribute further to your career in a Consultancy.

Conduct and/or Study Direct metabolism studies for new product development based on global regulatory requirements.

Main duties and responsibilities

* Act as Study Director, Analytical Project Manager and/or Principal Investigator on a wide range of metabolism studies.

* Study Direct more complex studies/bespoke new study types.

* 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.

* Mentor more junior Study Directors.

* 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.

* 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 and scientifically review reports written by other Study Directors.

* Work with Team Leader to prepare and maintain a library of generic study plans, template reports and cost builds for their area. Track actual vs budgeted hours on assigned studies ensuring any necessary changes are made to generic documents. Ensure work scope changes are flagged to management.

* Review proposals ensuring all costs are included and revenue recognition milestones are clear.

* Address findings arising from QA audits and process inspections.

* Effectively communicate with clients regarding study progress and address client comments.

* Actively participate in and where necessary lead client facility visits.

* Supervise and mentor members of staff and contribute to their training/development.

* As a recognised expert in a metabolism specialism increase profile of the department externally through playing an active role in expert groups, networking and publications.

QUALIFICATIONS

BSc or PhD in Chemistry or related discipline

Experience in Regulated Bioanalysis in a CRO or Pharmaceutical company Method Development & Troubleshooting

Expert in LC-MS/MS

Expert in Method Development & Troubleshooting

LIMS systems

Automation

Detailed knowledge of Regulated Bioanalysis guidelines

Large molecule bioanalysis

For more information please contact Abid Kanji and apply now.

METHOD DEVELOPMENT BIOANALYSIS METABOLISM IDENTIFICATION MET ID

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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