LBA Senior Scientist II (Responsible Scientist/Project Leader Role)

Synexa Life Sciences (Pty) Ltd.; Macclesfield; On-site; GBP 65,000 - 95,000; Full time

Job summary

Synexa Life Sciences (Pty) Ltd. is seeking an experienced Senior Scientist II (LBA) to lead bioanalytical and ligand binding assays in a regulated CRO setting. You will act as RS/SD/PI, overseeing development, validation, transfer and sample analysis with GxP compliance.

You will lead study teams, manage planning, reagent needs, troubleshooting and staff mentoring, while reviewing documentation and supporting client communications to ensure high-quality, compliant deliverables.

Qualifications

• Master’s degree in a natural science.
• 5+ years of relevant experience in bioanalytical assays.
• Strong knowledge of LC/MS, flow cytometry, and immunoassays.

Responsibilities

• Lead study-specific laboratory staff and ensure GxP compliance.
• Develop, validate, and apply bioanalytical and immunoassay methods for studies.
• Review project documents and manage client communication.
• Oversee study planning, reagent and capacity management.
• Mentor staff and support regulatory adherence.

Skills

5+ years of relevant experience

LC/MS

Flow cytometry

Immunoassays

GxP principles

Analytical techniques

Written and verbal English

Education

Master’s degree in natural science

Tools

Mass Spectrometry

MSD

Epoch

Flow cytometers

PCR systems

Job description

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.