Lead Bioanalytical Scientist

Placements24; Cape Town; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement savings plan

Professional development

Wellness initiatives

Cape Town facility

Job summary

Placements24 seeks a Lead Bioanalytical Scientist to steer development, validation, and implementation of bioanalytical assays in a Cape Town facility. This hands-on leadership role emphasizes scientific rigor and excellent project management to support drug development programs.

The successful candidate will oversee LC-MS/MS and immunoassay platforms, ensure regulatory compliance, and mentor a multidisciplinary team across PK/PD and DMPK interfaces.

Qualifications

• PhD or MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum 8 years of bioanalytical method development and validation experience.
• Experience with LC-MS/MS and immunoassay platforms.
• Proven track record in leading scientific teams.
• In-depth regulatory knowledge for bioanalysis in drug development.

Responsibilities

• Lead and manage a team of bioanalytical scientists with mentorship.
• Oversee development and validation of bioanalytical methods (LC-MS/MS, immunoassays).
• Ensure compliance with ICH, FDA, EMA guidelines.
• Troubleshoot complex analytical issues and optimize assays.
• Manage timelines and resources to meet deadlines.
• Review study protocols, validation reports, and raw data.
• Collaborate with PK/PD and DMPK departments.
• Maintain data integrity and quality assurance.

Skills

Bioanalytical leadership

Team leadership

Project management

LC-MS/MS expertise

Immunoassays

Data interpretation

Regulatory knowledge

Communication

Education

PhD or MSc in Analytical Chemistry / Biochemistry / Pharmaceutical Sciences

Tools

LC-MS/MS

Immunoassay platforms

Job description

About the Role

Our client, a prominent player in the pharmaceutical industry, is actively seeking an exceptional Lead Bioanalytical Scientist to enhance their operations in Cape Town, Western Cape . This leadership position is integral to the success of our analytical development and validation teams. The role requires a strategic thinker with a deep understanding of bioanalytical methodologies, particularly in the context of supporting drug development programs from early phase to late clinical stages. You will be responsible for overseeing the development, validation, and implementation of robust bioanalytical assays. The successful candidate will play a crucial role in ensuring the quality and integrity of data that supports regulatory submissions. This is a hands-on leadership role, demanding scientific rigor, meticulous attention to detail, and strong project management capabilities. The position is based in our client's state-of-the-art facility located in the vibrant city of Cape Town . As this is a critical laboratory-based role, it requires full-time presence at the site to ensure seamless integration with laboratory operations and team collaboration.

Key Responsibilities

• Lead and manage a team of bioanalytical scientists, providing technical expertise and mentorship.
• Oversee the development and validation of bioanalytical methods (e.g., LC-MS/MS, immunoassays) for small molecules and biologics.
• Ensure all bioanalytical activities comply with relevant regulatory guidelines (e.g., ICH, FDA, EMA).
• Troubleshoot complex analytical issues and implement effective solutions.
• Manage project timelines and resources efficiently to meet client and regulatory deadlines.
• Review and approve study protocols, validation reports, and raw data.
• Contribute to the design of preclinical and clinical study sample analysis plans.
• Collaborate with pharmacokinetics (PK), pharmacodynamics (PD), and DMPK departments.
• Maintain a high standard of scientific integrity and quality assurance in all laboratory operations.
• Stay current with scientific advancements and regulatory expectations in bioanalysis.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• A minimum of 8 years of experience in bioanalytical method development and validation within the pharmaceutical or biotechnology industry.
• Extensive experience with LC-MS/MS and/or various immunoassay platforms.
• Demonstrated experience in leading and managing scientific teams.
• In-depth knowledge of regulatory guidelines pertaining to bioanalysis for drug development.
• Proven ability to troubleshoot and optimize complex bioanalytical assays.
• Strong understanding of PK/PD principles and their application in drug development.
• Excellent data interpretation and reporting skills.
• Exceptional organizational and project management abilities.
• Strong interpersonal and communication skills, with the capacity to interact effectively with internal and external stakeholders.

Benefits

• Our client provides a competitive salary package, commensurate with experience and qualifications.
• Beyond that, we offer comprehensive health insurance coverage.
• A generous retirement savings plan.
• Opportunities for continuous professional development through training programs and conference attendance.
• Employees also have access to various wellness initiatives and a supportive work environment.
• This role in Cape Town is an excellent opportunity for a seasoned professional looking to advance their career in a dynamic and innovative pharmaceutical company.