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Senior Technical Specialist, Bioanalysis

4 months ago

Rushden, United Kingdom Pharmaron Full time

Pharmaron is a premier R&D service company supporting the life sciences industry and is staffed by over 7,000 employees in North America, Europe, Japan and China.

The Rushden site is 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).

**Key Roles and Responsibilities**:

- Perform complex method development/validation on large and small molecules.
- Provide analytical trouble shooting support across the department.
- Responsible for technical training (writing and review of training materials) and maintenance of laboratory work standards in their area.
- Mentor new Technical Specialists and other senior laboratory staff.
- 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.
- Effectively communicate with internal stakeholders and clients regarding study progress.
- Identify new technologies, which could be of significant benefit to the group, improving capability or reducing operational costs.
- Lead process improvement/new service development projects in their specialist area.
- Act as an interface with contract service support provider for LC-MS/MS.
- Increase the profile of the department externally through playing an active role in expert groups, networking and publications.
- Lead implementation of continuous improvement culture in specialist area proposing process improvement/new service offering initiatives to the Metabolism leadership team.
- 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.

**Qualification**

**Responsibilities**
- Many years’ experience of regulated small and/or large molecule bioanalysis including method development and validation of LC-MS methods and trouble shooting in a CRO or Pharmaceutical Company
- Experienced Study Director/Analytical Project Manager in a GLP/GCP facility
- Extensive experience of using quantitative Mass Spectrometers e.g. Sciex 5500 and 6500
- Recognised expert in Bioanalysis with deep knowledge of the of development and validation of quantitative LC-MS methods
- Expert in the development of sample extraction and work-up methods including use of automation platforms (e.g. Hamilton, Tecan)
- Proficient in the use of relevant software e.g. Analyst and Watson
- Thorough understanding of the regulated bioanalysis guidelines
- Project Management
- Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2003, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China_

**Benefits**:

- Additional leave
- Company pension
- Cycle to work scheme
- Flexitime
- Free parking
- On-site gym
- On-site parking
- Referral programme
- Sick pay

Schedule:

- Day shift
- Flexitime
- Monday to Friday

Work Location: In person