Role Overview
We are seeking a Senior Scientist I to lead LC-MS/MS bioanalytical laboratory studies, develop and validate bioanalytical and immunological assays, and ensure regulatory compliance, driving high-quality study delivery and scientific excellence. Key Responsibilities
Required:
We are seeking a Senior Scientist I to lead LC-MS/MS bioanalytical laboratory studies, develop and validate bioanalytical and immunological assays, and ensure regulatory compliance, driving high-quality study delivery and scientific excellence. Key Responsibilities
- Lead study specific laboratory staff and ensure compliance with GxP and latest guidelines.
- Write and review SOPs and support method documentation.
- 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.
Required:
- Master’s degree in a natural science or 4-5 years’ relevant experience.
- Strong knowledge of analytical techniques and hands-on experience with LC/MS and GxP principles (GLP, GCP, GMP, GCLP).
- Proficient with advanced instruments (e.g., Mass Spectrometry).
- 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.
- Experience in GxP-accredited labs.
- Willingness to travel as needed.
Vacancy posted a month ago
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