About the Role
Our client, a leading biopharmaceutical company at the forefront of medical innovation, is seeking a highly skilled Senior Bioanalytical Scientist for their fully remote research team. This role offers the unique opportunity to contribute to cutting-edge drug development from the convenience of your home office. You will be responsible for developing, validating, and implementing bioanalytical methods to quantify drug substances, metabolites, and biomarkers in various biological matrices such as plasma, serum, urine, and tissue. This position requires a deep understanding of analytical chemistry, mass spectrometry (LC-MS/MS), and immunoassay techniques, along with a proven track record in method development and troubleshooting. As a remote-first organization, we are committed to providing a collaborative virtual environment where scientific excellence can flourish. You will work closely with pharmacokineticists, toxicologists, and clinical teams to support preclinical and clinical studies. We are looking for a motivated and detail-oriented scientist passionate about advancing drug development through robust bioanalytical support. Your expertise will be critical in providing reliable data to inform critical decisions throughout the drug lifecycle.
Key Responsibilities
- Develop, validate, and transfer bioanalytical methods for small molecules and/or large molecules using techniques such as LC-MS/MS, ELISA, and other immunoassays.
- Perform bioanalytical testing to support preclinical and clinical development programs according to regulatory guidelines (e.g., FDA, EMA).
- Analyze and interpret complex datasets, troubleshoot assays, and ensure data integrity and quality.
- Prepare validation reports, study reports, and other necessary documentation for regulatory submissions.
- Maintain laboratory instrumentation and ensure compliance with GLP/GCP guidelines.
- Collaborate with internal and external partners, including project managers, study directors, and clients.
- Stay current with the latest advancements in bioanalytical science and technology.
- Contribute to the optimization of laboratory processes and workflows.
- Mentor junior scientists and provide technical guidance.
Requirements
- Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of hands-on experience in bioanalytical method development and validation in a pharmaceutical or CRO setting.
- Extensive experience with LC-MS/MS instrumentation and associated software is essential.
- Proficiency in developing assays for small molecules and/or large molecules (peptides, proteins, antibodies).
- Strong understanding of GxP regulations and requirements for bioanalytical studies.
- Excellent analytical, problem-solving, and organizational skills.
- Ability to work independently, manage multiple projects, and meet deadlines in a remote environment.
- Strong written and verbal communication skills for effective collaboration and reporting.
- Experience with immunoassay techniques (e.g., ELISA) is a plus.
- Familiarity with ligand-binding assays for biologics is advantageous.
Benefits
- Our client offers a competitive salary, performance bonuses, and a comprehensive benefits package including health, dental, and vision insurance.
- This role is fully remote, providing significant flexibility.
- Enjoy the convenience of working from your preferred location near Nelspruit, Mpumalanga, ZA , or anywhere else.
- We provide a robust retirement savings plan with company matching.
- Professional development is supported through access to scientific conferences, workshops, and online training.
- Generous paid time off, including vacation, sick leave, and public holidays, is provided.
- Join an innovative team focused on delivering high-quality bioanalytical data to support life-saving therapies.