Intertek UK
Scientist – LCMS Analytical
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About You
We are seeking an experienced bioanalytical scientist with a strong background in LCMS/MS quantitative analysis and pharmacokinetic (PK) studies, ideally with practical experience within a regulated laboratory environment. You will have a BSc, MSc or PhD in Biology, Chemistry or a related scientific discipline, together with a detailed understanding of bioanalytical methodologies and regulatory expectations.
Required Skills and Experience
- BSc / MSc/ PhD in Biology/Chemistry (or related scientific discipline) is essential.
- In-depth knowledge of LCMS/MS and experience performing quantitative pharmacokinetic (PK) analysis.
- Comprehensive experience of working in a GxP regulatory laboratory with an understanding of GLP/GCP/GMP principles.
- Specialist Method development and validation experience (ICH M10) for LCMS/MS PK analysis.
- Practical knowledge of techniques to extract pharmaceuticals and biopharmaceuticals (small/large molecule) from biological matrices (e.g. serum, plasma and urine).
- Experience training, supervising and coordinating the work of more junior scientists.
- Good practical laboratory and problem-solving skills.
- Good IT literacy skills.
- Strong numeracy skills with the knowledge of calculating and tabulating results.
- Clear written and verbal communications skills with the ability to clearly convey processes, results and key messages and able to build rapport, quickly and effectively.
- Good interpersonal skills with the ability to collaborate with all areas of the business.
- The ability to effectively time manage personal workload and work on multiple projects as required.
- Good comprehension skills with the ability to interpret analytical information and convert this into a technical report or Certificate of analysis.
- Knowledge and application of appropriate systems and procedures relevant to scientific and analytical methodologies, required regulatory standards, research/regulatory procedures and instructions.
- Knowledge and application of safety procedures, laboratory performance standards, handling biological samples, chemicals, COSHH, GMO, SHE and enforcement of safety and quality systems.
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About the Opportunity
The Scientist position is an onsite laboratory-based role within the Operational team. The primary focus is performing LCMS/MS analysis in a GLP, GCP and GMP accredited laboratory. The candidate will have experience of Developing and Validating LCMS/MS methods following ICH M10 guidelines for pharmacokinetic (PK) analysis. The role requires in-depth understanding of LCMS/MS and experience of pharmacokinetic (PK) analysis for pharmaceuticals / biopharmaceuticals (for example small molecules, proteins, peptides, lipids and oligonucleotides) in clinical and non-clinical samples. A Scientist is expected to be an independent member of the lab team and will work across a vast array of projects which will range in scale, scope and timelines.
Key Activities
- In-depth understanding of LC-MS/MS and the application to pharmaceuticals/bioanalytical analysis.
- Expertise in all practical aspects of quantitative pharmacokinetic (PK) analysis utilizing LCMS/MS.
- Provide specialist expertise of method development and validation in accordance with ICH M10 guidelines for quantitative LC-MS/MS PK methods with minimal supervision.
- Experience working with and extracting pharmaceuticals and biopharmaceuticals (small/large molecule) from biological matrices (e.g. serum, plasma and urine) and/or pharmaceutical matrices.
- Performing analytical services for customers in the pharmaceutical and bioanalytical sectors in accordance with GLP, GCP and GMP guidelines.
- Ability to work unsupervised, planning and performing analytical work, generating and interpreting data and generating reports when required.
- Ability to problem solve autonomously without relying on specific written procedures; draw on literature to formulate best plan of action involving staff from other teams as necessary.
- Confident communicating directly with clients; establish requirements and report outcomes; implications of the results generated; formulating and advising optimum strategies to tackle problems.
- Training and/or mentoring of junior staff.
- Demonstration of commercial awareness supporting Business Development in the generation of quotes within the technical area of expertise.
- Ensuring studies meet the required quality standards and that are fit for purpose according to clinical phase and regulatory expectations.
- Ability to learn new techniques within the laboratory and work in new areas if required.
- Ability to work as part of a team with good written and verbal communication skills.
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What We Offer
Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and we thrive working together with precision, pace, and passion.
We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.
- Competitive salary/benefits
- Development and career opportunities around the Globe
- Working in a highly motivated team and dynamic working environment
We are an Equal Opportunity Employer and are committed to creating an inclusive workplace. We do not discriminate against applicants, and all qualified individuals will receive consideration for employment regardless of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, colour, nationality, ethnic or national origin, religion or belief, sex, or sexual orientation.
We are committed to fair and equitable pay and are proud to be a Real Living Wage employer, ensuring our colleagues are compensated in line with independently assessed living standards. We are also committed to providing reasonable adjustments throughout the recruitment process and employment to support candidates and employees with disabilities or special needs.
Intertek operates a preferred supplier arrangement, and we do not accept unsolicited approaches from agencies.
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