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Senior scientist ii

Macclesfield
Scientist
Posted: 23 August
Offer description

Job Purpose As a Senior Scientist II, you’ll lead laboratory studies, drive the development and validation of bioanalytical and immunological assays, and ensure compliance with GxP and global regulatory standards. You’ll manage projects end-to-end, mentor teams, and partner with clients while shaping innovative solutions in a dynamic scientific environment. Main Areas of Responsibility Lead study specific laboratory staff and ensure compliance with GxP and latest guidelines. Develop, validate, and apply bioanalytical and immunological assays for pre-clinical, clinical studies, and drug batch characterization as Responsible Scientist (RS), Study Director (SD) or Principal Investigator (PI). Study specific consultation, capacity management, reagent planning, inventory, troubleshooting, and training. Conduct and manage sample analysis, validaton and method development studies. Draft and review project documents (e.g., lab manuals, validation plans, sample analysis reports), ensuring high-quality reporting and client communication. Lead studies, manage pre- and post-contract phases (change order management, reagent plans, protocols, quotes), and support revenue generation. Maintain ERP timesheets and unit logging, provide training, and contribute to achieving monthly revenue targets. Stay updated on bioanalysis trends, continuous GxP-related training, implement EMA/FDA guidelines, assess systems for improvements, and share knowledge regularly. Ensure compliance with regulatory guidelines by maintaining SOPs, policies, and study documentation, and providing staff training and support. Qualifications & Experience Required: Master’s degree in a natural science or 5 relevant experience. Strong knowledge of analytical techniques (e.g., LC/MS, flow cytometry, immunoassays etc.) and GxP principles (GLP, GCP, GMP, GCLP). Proficient with advanced instruments (e.g., Mass Spectrometry, MSD, Epoch, flow cytometers, PCR systems). Proficient in following protocols, and using standard equipment (centrifuges, biosafety cabinets, incubators). Good command of written and spoken English, with strong collaboration and negotiation skills. Desirable: Experience in GxP-accredited labs. Willingness to travel as needed. PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.

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