About the Role Our client is seeking an accomplished Lead Formulation Scientist to spearhead the development of innovative pharmaceutical dosage forms. This critical role, based in George, Western Cape, offers a unique opportunity to influence the formulation strategy from concept to commercialization. You will lead a dedicated team of formulation scientists, leveraging your extensive expertise to design, optimize, and scale up various drug delivery systems. The position demands a deep understanding of pharmaceutical sciences, excipient compatibility, and manufacturing processes. You will collaborate closely with analytical development, regulatory affairs, and manufacturing teams to ensure seamless product development and successful regulatory submissions. This is an exciting chance to contribute to life-saving medicines and shape the future of pharmaceutical formulation within a supportive and growing organization.
Key Responsibilities
- Lead the formulation development of various pharmaceutical products, including solid oral dosage forms, injectables, and topical preparations.
- Oversee the design, execution, and interpretation of pre-formulation studies, stability testing, and process development experiments.
- Develop and optimize formulation prototypes, ensuring desired drug release profiles, bioavailability, and product stability.
- Mentor and guide junior formulation scientists, providing technical expertise and fostering a culture of continuous improvement.
- Collaborate with analytical development teams to define critical quality attributes and develop appropriate testing methods.
- Liaise with regulatory affairs to ensure all formulation development activities comply with ICH guidelines and other relevant regulatory requirements.
- Support technology transfer activities to manufacturing sites, ensuring successful scale-up and commercial production.
- Evaluate and select appropriate excipients and processing technologies for new product development.
- Prepare comprehensive documentation, including development reports, CMC sections for regulatory filings, and scientific presentations.
Requirements
- Master's degree or Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
- A minimum of 8 years of progressive experience in pharmaceutical formulation development.
- Proven track record of successfully developing and launching pharmaceutical products.
- Extensive knowledge of drug delivery systems, solid state chemistry, and material science.
- Experience with various dosage forms, including tablets, capsules, sterile products, and topical formulations.
- Strong understanding of GMP, ICH guidelines, and regulatory submission requirements.
- Excellent leadership, project management, and communication skills.
- Ability to work effectively in a cross-functional team environment.
- Hands-on experience with common pharmaceutical formulation and manufacturing equipment.
- Proficiency in statistical analysis and design of experiments (DoE) is a plus.
Benefits
- Our client offers a competitive salary of ZAR per annum, along with comprehensive health, dental, and vision coverage.
- We provide generous paid time off, including annual leave and sick days.
- Opportunities for professional development, including conference attendance and further training, are readily available.
- A retirement savings plan is offered with employer contributions.
- This role is based in George, Western Cape, offering a stimulating work environment and the chance to be part of a growing pharmaceutical leader.