Position Overview: We are seeking a highly skilled and experienced Drug Substance Process Development Consultant to join our team. The ideal candidate will have a strong background in small molecule drug development, with a focus on early-stage development. This role involves providing technical expertise, optimizing manufacturing processes, and ensuring successful scale-up and transfer of drug substances.
Key Responsibilities:
- Lead the development and optimization of drug substance manufacturing processes for small molecules in early-stage development.
- Collaborate with cross-functional teams to ensure alignment and integration of process development activities.
- Conduct process characterization, scale-up, and technology transfer to manufacturing sites.
- Identify and address challenges related to solubility, bioavailability, and stability of small molecule drug substances.
- Develop and implement strategies for efficient and cost-effective process development.
- Provide technical support and troubleshooting for manufacturing processes.
- Author and review process descriptions, batch records, and related documentation.
- Ensure compliance with regulatory requirements and industry standards.
- Stay updated on the latest advancements in small molecule drug development and process technologies.
