About the Role
Our client is a leading biopharmaceutical company committed to discovering and developing innovative medicines to treat debilitating diseases. We are seeking a highly skilled and experienced Senior Pharmaceutical Development Chemist to join our drug substance development team, working a hybrid schedule from our R&D center in Soweto, Gauteng . This role is essential for the chemical development and optimization of active pharmaceutical ingredients (APIs) from early discovery through to late-stage clinical development. The ideal candidate will possess a strong background in synthetic organic chemistry, process chemistry, and analytical techniques, with a proven track record in scaling up chemical processes. You will be responsible for designing and executing synthetic routes, troubleshooting process issues, and ensuring the efficient and safe production of high-quality APIs. This position offers a significant opportunity to contribute to the development of novel therapeutics and advance your career in a dynamic research environment. Our state-of-the-art facilities in Soweto, Gauteng support cutting-edge chemical development.
Key Responsibilities
- Design and optimize synthetic routes for active pharmaceutical ingredients (APIs) for new chemical entities (NCEs).
- Develop robust, scalable, and cost-effective manufacturing processes for APIs suitable for clinical trials and commercial supply.
- Execute laboratory-scale syntheses and process validation studies.
- Troubleshoot and resolve chemical synthesis and process-related issues.
- Characterize APIs using a variety of analytical techniques (e.g., NMR, MS, HPLC, GC, XRPD, DSC).
- Perform impurity profiling and develop strategies for impurity control.
- Conduct forced degradation studies and elucidate degradation pathways.
- Collaborate closely with medicinal chemists, analytical chemists, formulation scientists, and manufacturing teams.
- Ensure all development activities comply with cGMP regulations and relevant safety guidelines.
- Prepare comprehensive technical reports, process descriptions, and documentation for regulatory submissions.
- Stay current with advancements in synthetic chemistry, process development, and pharmaceutical manufacturing technologies.
Requirements
- Ph.D. in Organic Chemistry, Process Chemistry, or a related field.
- Minimum of 5 years of post-doctoral or industry experience in pharmaceutical process chemistry and development.
- Proven expertise in synthetic organic chemistry and route scouting for complex molecules.
- Strong understanding of process development principles, scale-up challenges, and cGMP requirements.
- Hands-on experience with analytical techniques for chemical characterization and purity assessment.
- Experience in impurity identification and control strategies.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present scientific data effectively.
- Ability to work independently and lead projects in a collaborative, hybrid R&D setting.
- Experience in hazardous reaction evaluation and process safety is a plus.
- Must be able to work from our R&D center in Soweto, Gauteng on a hybrid schedule.
Benefits
- Our client offers a competitive salary commensurate with your experience and expertise, along with annual performance-based bonuses.
- A comprehensive benefits package includes excellent medical, dental, and vision insurance coverage.
- A robust retirement savings plan with employer matching contributions is available.
- Employees enjoy generous paid time off, including vacation days, sick leave, and public holidays.
- Our client is committed to professional growth, providing opportunities for further education, attendance at scientific conferences, and advanced training.
- We offer access to modern laboratories and cutting-edge scientific equipment, fostering an innovative and collaborative work culture.
- A focus on work-life balance is maintained.
- Relocation assistance may be provided for exceptional candidates willing to relocate to Soweto, Gauteng .