Senior Bioanalytical Scientist

Placements24; Pretoria; Hybrid; ZAR 1,100,000 - 1,600,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Professional development

State-of-the-art instrumentation

Job summary

Placements24 in Pretoria is seeking a Senior Bioanalytical Scientist to enhance analytical capabilities in a dynamic research setting. You will develop, validate, and transfer bioanalytical methods (LC-MS/MS, ELISA) for biopharmaceuticals across diverse matrices, supporting PK/PD and immunogenicity assessments with GLP compliance.

The role emphasizes data integrity, regulatory submissions, and collaboration within a dedicated team, with potential for hybrid work arrangements in Pretoria.

Qualifications

• Ph.D. or Master’s degree in Analytical Chemistry, Biochemistry, or related field.
• Minimum 5 years of hands-on bioanalytical method development and validation experience in pharma/biotech.
• Proficiency with LC-MS/MS instrumentation and related software.
• Strong understanding of GLP regulatory requirements for bioanalytical studies.
• Excellent data analysis, problem-solving, and organizational skills.

Responsibilities

• Develop, validate, and transfer bioanalytical methods (LC-MS/MS, ELISA) for small molecules and biologics in various matrices.
• Execute studies to support PK/PD and immunogenicity assessments.
• Perform method validation per regulatory guidelines (FDA/EMA).
• Troubleshoot analytical issues and optimize methods for sensitivity and robustness.
• Analyze data and contribute to regulatory submissions and data integrity under GLP.

Skills

LC-MS/MS

ELISA

Data analysis

GLP regulatory knowledge

Problem solving

Team collaboration

Education

Ph.D. or Master’s in Analytical Chemistry/ Biochemistry

Tools

LC-MS/MS software

Job description

About the Role

Our client is seeking a highly skilled Senior Bioanalytical Scientist to enhance their analytical capabilities in Pretoria . This role is crucial for supporting the development and characterization of biopharmaceuticals by developing, validating, and executing robust bioanalytical methods. You will work within a dedicated team, ensuring the accurate and reliable quantification of drugs and biomarkers in various biological matrices. This position provides an exciting opportunity to contribute to critical drug development programs and advance analytical science in a dynamic research environment, with potential for hybrid work flexibility.

Key Responsibilities

• Develop, validate, and transfer bioanalytical methods (e.g., LC-MS/MS, ELISA) for small molecules and biologics in various biological matrices.
• Execute bioanalytical studies to support pharmacokinetic, pharmacodynamic, and immunogenicity assessments.
• Perform method validation according to regulatory guidelines (e.g., FDA, EMA).
• Troubleshoot analytical issues and optimize existing methods to improve sensitivity, specificity, and robustness.
• Analyze and interpret bioanalytical data, ensuring data integrity and compliance with GLP standards.
• Author study protocols, validation reports, and contribute to regulatory submissions.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Biochemistry, or a related scientific discipline.
• Minimum of 5 years of hands-on experience in bioanalytical method development and validation in a pharmaceutical or biotech setting.
• Proficiency with LC-MS/MS instrumentation and associated software.
• Strong understanding of regulatory requirements for bioanalytical studies (GLP).
• Excellent data analysis, problem-solving, and organizational skills.
• Ability to work effectively both independently and as part of a team in Pretoria .

Benefits

• Competitive salary and performance bonus structure.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan options.
• Professional development opportunities, including training and conference participation.
• A collaborative and innovative work environment with state-of-the-art analytical instrumentation.