About the Role
Our client, a groundbreaking biopharmaceutical company focused on innovative drug delivery systems, is seeking a talented Senior Formulation Scientist to join their Research and Development team. This role is instrumental in the development of novel drug products from concept through to clinical trial material. Situated in the beautiful academic hub of Stellenbosch, Western Cape , this position offers a hybrid work model, providing flexibility while ensuring close collaboration with laboratory and project teams. The Senior Formulation Scientist will be responsible for designing, developing, and characterizing complex pharmaceutical formulations, with a strong emphasis on oral dosage forms. You will leverage your expertise in pharmaceutical sciences to drive projects forward and contribute to the company's pipeline of advanced therapeutics.
Key Responsibilities
- Design and develop innovative pharmaceutical formulations for various dosage forms, with a primary focus on oral solid dosage forms (tablets, capsules).
- Conduct pre-formulation studies to understand drug substance properties and their impact on formulation development.
- Select appropriate excipients and optimize formulation composition to achieve desired drug release profiles, stability, and bioavailability.
- Develop and validate analytical methods for characterization of drug products (e.g., HPLC, dissolution testing, particle size analysis).
- Perform stability studies according to ICH guidelines and interpret the results to establish shelf-life and storage conditions.
- Lead formulation development projects, manage timelines, and coordinate activities with internal and external stakeholders.
- Troubleshoot formulation and process-related issues encountered during development.
- Prepare comprehensive development reports, technical summaries, and documentation for regulatory submissions.
- Stay updated on the latest advancements in pharmaceutical formulation science, drug delivery technologies, and regulatory guidelines.
- Collaborate effectively with teams in manufacturing, analytical development, and regulatory affairs in a hybrid work setting.
Requirements
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical formulation development, preferably within a biopharmaceutical or pharmaceutical company.
- Strong theoretical and practical knowledge of solid dosage form development, including granulation, tableting, and coating.
- Experience with various analytical techniques relevant to drug product characterization (e.g., dissolution, HPLC, Karl Fischer).
- Familiarity with ICH stability guidelines and regulatory requirements for drug product development.
- Proven ability to manage multiple projects simultaneously and work effectively in a fast-paced environment.
- Excellent problem-solving, critical thinking, and decision-making skills.
- Strong written and oral communication skills, with the ability to present scientific data clearly.
- Experience with statistical analysis and design of experiments (DoE) is advantageous.
- Comfortable working in a hybrid model, balancing laboratory work with remote documentation and project management.
Benefits
- Competitive salary commensurate with experience and qualifications.
- Annual performance-based bonus.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with employer match.
- Generous paid time off and holiday leave.
- Opportunities for professional development, including conference attendance and advanced training.
- Access to cutting-edge R&D facilities and equipment.
- A collaborative and innovative work environment.