About the Role
Our client, a globally recognized pharmaceutical leader, is seeking an experienced and innovative Lead Biologics Formulation Scientist to join their state-of-the-art facility in Cape Town, Western Cape. This critical role will lead the formulation development of complex biologic drug products, from early-stage development through to commercialization. You will be responsible for designing and optimizing stable, effective, and patient-centric formulations for a range of therapeutic proteins and antibodies. This position offers a unique opportunity to contribute to the development of life-changing medicines within a high-energy, collaborative research and development environment in Cape Town. The ideal candidate will possess a deep understanding of protein chemistry, biophysical characterization techniques, and formulation strategies for parenteral delivery systems. We are looking for a scientific leader who can guide a team and drive innovation in formulation science, ensuring the highest quality standards are met. The successful applicant will play a key part in shaping the future of our client's biologics pipeline.
Key Responsibilities
- Lead the formulation development strategy for new biologic drug candidates, including monoclonal antibodies, recombinant proteins, and vaccines.
- Design and execute formulation studies to ensure product stability, efficacy, and manufacturability.
- Develop and optimize formulations for various delivery routes, including subcutaneous, intramuscular, and intravenous.
- Utilize a wide range of biophysical characterization techniques (e.g., DLS, DSC, CD spectroscopy, HPLC) to understand protein behavior in solution and solid states.
- Perform forced degradation studies and develop strategies to mitigate degradation pathways.
- Troubleshoot formulation-related issues and provide scientific expertise to manufacturing and process development teams.
- Collaborate with analytical development to establish appropriate specifications and release methods.
- Manage external contract research organizations (CROs) for specific formulation development activities.
- Stay current with scientific advancements and industry trends in biologics formulation and drug delivery.
- Mentor and guide junior scientists within the formulation team.
- Prepare technical reports, summaries, and contribute to regulatory filings.
Requirements
- Ph.D. or Master's degree in Pharmaceutics, Biochemistry, Chemistry, Chemical Engineering, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical formulation development, with a significant focus on biologics.
- Demonstrated expertise in formulating therapeutic proteins, antibodies, or other large molecules.
- Hands-on experience with biophysical characterization methods and interpretation of results.
- Strong understanding of protein degradation pathways and stabilization strategies.
- Experience with parenteral dosage forms (e.g., solutions, suspensions, lyophilized products) and associated manufacturing processes.
- Proven leadership skills and experience managing scientific projects and/or teams.
- Excellent communication, interpersonal, and presentation skills.
- Ability to work effectively in a cross-functional team environment.
- Experience with regulatory requirements for biologics is a plus.
- Proficiency in relevant software for data analysis and scientific documentation.
Benefits
- Our client offers a competitive salary, a performance-based bonus structure, comprehensive medical and dental coverage, and an excellent retirement fund.
- Employees enjoy generous vacation time, professional development opportunities, and access to cutting-edge laboratory equipment in our modern Cape Town facility.
- We are committed to fostering a culture of innovation and scientific excellence, providing a work environment that encourages growth and collaboration.
- This role presents a significant career advancement opportunity within a thriving pharmaceutical sector.
- Further details regarding compensation and benefits will be provided during the interview process.
- Our client also provides support for ongoing education and participation in key industry conferences.