Senior Scientist II (Responsible Scientist/Project Leader Role)

Role Overview

We are seeking an experienced Senior Scientist II (LBA) to lead bioanalytical and Ligand Binding Assay (LBA) studies in a regulated CRO environment. Acting as a Responsible Scientist (RS), Study Director (SD), or Principal Investigator (PI), you will oversee LBA assay development, validation, transfer, and sample analysis while ensuring compliance with GxP requirements and current regulatory guidelines.

This role includes leading study-specific laboratory teams, managing study planning, reagent and capacity requirements, troubleshooting complex LBA and immunological assay challenges, and mentoring staff. You will also be responsible for reviewing project documentation, supporting client communication, managing study deliverables, driving continuous process improvements, and ensuring adherence to SOPs, regulatory requirements, and quality standards.

Key Responsibilities

• 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.
• Observe appropriate regulatory guidelines, SOPs, policies and study documentation.
• Working in accordance with standard operating procedures (SOPs) by authoring, reviewing, and maintaining SOPs, guidance documents, and policies, as well as providing training and support to staff.

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).
• Profiecient in following protocols, and using standard equipment (centrifuges, biosafety cabinets, incubators).
• Good command of written and spoken English, with strong collaboration and negotiation skills.

Preferred

• Experience in GxP-accredited labs.
• Willingness to travel as needed.

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