Senior Scientist

Job title:

Senior Scientist

Company

Intertek

Job description

Job Description:ABOUT YOUAs Senior Scientist, you will lead the Analytical/ Physical characterisation of biopharmaceutical products. Contributing to the development and optimisation of drug method development and validation strategies in line with regulatory requirements.Required skills and experience:

• BSc / MSc/ PhD in Biology/Chemistry (or related scientific discipline) is essential.

5 years of relevant industry experience * Strong numeracy skills with the knowledge of calculating and tabulating results

• IT proficient
• Comprehensive experience of working in a GxP regulatory laboratory with strong understanding of GMP, GLP and/or GCP principles.
• Strong method development and validation experience (ICH Q2(R2) Validation of Analytical Procedures)
• You should also be able to demonstrate experience of training, supervising, and coordinating the work of more junior analysts.
• 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

ABOUT THE OPPORTUNITYIn the role of senior scientist, you will be responsible for designing, developing, and applying methods to evaluate the performance, stability, and quality of biologic/ pharmaceutical products, ensuring compliance with industry standards and regulatory guidelines.Key activities:

• Analytical Characterisation: Lead the physical characterisation of biologic and pharmaceutical products, including proteins, peptides, monoclonal antibodies, vaccines, and other biologic formulations. Develop and optimise methods to analyse physical properties such as surface characteristics, molecular weight, protein conformation, stability, aggregation state, particle size, charge, stability, using techniques (e.g., Dynamic Light Scattering, Light Scattering, and Viscosity Measurements, Differential Scanning Calorimetry, Brunauer-Emmett-Teller, Powder X-ray diffraction, Analytical Ultracentrifugation, Circular Dichroism, TGA, FTIR among other techniques).
• Documentation: Prepare and review scientific documentation such as technical reports, validation reports, method development protocols, white papers and stability study reports. Ensure all Analytical data complies with GLP and GMP requirements.
• Cross-functional Collaboration: Work closely with the Business development team, Project managers, Quality assurance, and regularly attending customer calls, and prepare PowerPoint presentations to ensure smooth coordination of method development / validation activities for multiple techniques. Collaborate with internal and external teams to ensure timely project delivery and resolve any technical issues related to Analytical characterisation.
• Project Management & Leadership: Lead and manage method development/ validation projects, ensuring they meet timelines, budgets, and quality standards. Mentor junior scientists and contribute to team training, ensuring continuous development of technical expertise in Analytical and characterisation techniques, and advise on regulatory requirements. Prepare and present project updates, study results, and strategic recommendations to external customers, and attend conferences.
• Troubleshooting: Troubleshoot technical challenges and provide expert solutions to overcome obstacles in product characterization. Raising OOT/ OOS and lab investigations. Proactively identify and implement improvements in methodologies to enhance the efficiency, robustness, and scalability of Analytical assays.
• Data Analysis and Reporting: Perform data analysis and interpretation of analytical results, ensuring clear documentation of findings. Contribute to the preparation of scientific reports, peer-reviewed publications, and presentations for internal and external dissemination.
• Plan work to ensure that priorities and deadlines are achieved ensuring prompt responses to incoming communications (telephone, email etc)

WHAT WE OFFERJoin 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 who do not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies.

Expected salary

Location

Lancashire

Job date

Sat, 21 Dec 2024 05:41:40 GMT

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