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Date Added: Wed 22/06/2022

Senior Technical Specialist- Bioanalysis

NN10, UK
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Company: PHARMARON

Job Type: Permanent, FullTime

We offer:

* Vibrant and dynamic employment - we are a highly specialised, growth company operating in a critical sector of the economy - our future is strong and exciting

* Opportunities to develop your skills and yourself - our rapid growth brings greater opportunities for you to learn and grow faster!

* A great team where we all support each other - enjoy your work - after all you spend about a third of your time here!

Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world's leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.

We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.

The role is based in Northamptonshire, in the town of Rushden. 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, Plant Metabolism and Metabolite Identification) in addition to Chemistry (which includes API and IMP manufacture). We offer our employees a supportive teamwork environment, enabling them to develop and liberate their true potential.

The position we are seeking to fill is for a Senior Technical Specialist Quantitative Mass Spectroscopy (Bioanalysis) to use their expertise in quantitative LC-MS/MS to develop/validate and trouble shoot methods for regulated bioanalysis and other areas of the department.

-We offer state of the art equipment and facilities at our Rushden site

-We offer a competitive salary and a progressive and comprehensive suite of employee benefits

Requirements:

-PhD, MSc or BSc (Hons) in Chemistry or related subject

-Multi 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

-Expertise 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

-Proficient in the use of PK software e.g. WinNonLin

-Project Management

-Scientific data interpretation, reporting and presentation skills

-Effective written and verbal communication skills, including the ability to effectively present scientific findings to colleagues and clients

-Understanding of the drug development process

-Good knowledge of Microsoft Office software

-Coaching & Mentoring

Responsibilities:

The successful candidate will have responsibilities for:

-Performing complex method development/validation on large and small molecules.

-Providing analytical trouble shooting support across the department, as required.

-Responsible for technical training (writing and review of training materials) and maintenance of laboratory work standards in their area.

-Mentoring new Technical Specialists and other senior laboratory staff.

-Taking 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.

-Calculating and QC checking data.

-Processing sample batches, as required.

-Reviewing data obtained and preparing study updates and study data for discussion internally and for communication to the client.

-Effectively communicating with clients regarding study progress and address client comments.

-Identifying 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, calling engineers and managing instrument break-downs to ensure minimum instrument down-time.

-Maintaining and writing SOPs, as required.

-Manage and maintain instrument maintenance records, ensuring they comply with departmental SOPs and are available at all times for QA or external auditor inspection.

-Holding equipment/software/ lab space responsibilities on behalf of their team.

-As a recognised expert in Bioanalysis 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.

-Act as Study Director, Analytical Project Manager and/or Principal Investigator on a wide range of Metabolism (area e.g. ADME, In Vitro & DDI, Env. Fate, Plant Metabolism and Bioanalysis) studies and/or be a subject matter expert in a particular discipline.

-Preparing worksheets to coordinate experimental activities.

-Preparing study plans, amendments, file notes and deviations, as required

-Preparing study reports/report sections and scientifically review reports written by other Study Directors.

-Addressing findings arising from QA audits and process inspections.

-Working with Team Leader to prepare and maintaining 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.

-Reviewing proposals ensuring all costs are included and revenue recognition milestones are clear.

-Actively participating in and where necessary lead client facility visits.

Why Should You Apply?

-This is an opportunity for you as an experienced Technical expert with experience in method development to demonstrate your ability to make a real impact in a highly scientific and regulated environment

-To be part of a team who support each other and put excellence at the heart of all that we do

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 12,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China
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