Job Details
Our client, a thriving clinical stage biotech in California, is seeking a highly qualified and talented candidate for their team. Key functions of this exciting and fully remote role will involve:
- Independently design synthetic routes to target molecules, conduct Process Research and Development, and manage API process research and development projects to develop cost-efficient, scalable and robust drug substance manufacturing processes.
- Establish drug substance (including the related raw materials and intermediates) development manufacturing routes and strategies.
- Provide strategic planning as well as technical support and oversee and manage contract manufacture organization (CDMO s) to prepare manufacturing batches, development reports and other development-related documents.
- Guide external third parties through technology transfer, process development, optimization, qualification and validation of the activities related to DS manufacturing operations. Be on-site, as necessary.
- Collaborate with other functions to assure compliance with applicable GMP and global regulatory requirements.
- Author and review of CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs).
- Provide technical strategic support and documentation for answering questions during regulatory submission reviews.
- Supervise and manage CMC chemists and related staff.
They are looking for a candidate with:
- Ph.D. in organic chemistry or related discipline.
- A minimum of 12+ years industry experience in process research and development and CDMO management.
- Strong knowledge cGMP requirements relating to drug substance.
- Strong knowledge of drug substance process development and manufacture for early development. Knowledge of late development such as process registration, validation, and launch, a plus.
- Excellent planning and organizational skills.
- Able to make international and domestic travels.
- Thorough understanding of cGMP compliance and ICH guidelines.
- Experience with managing outsourced projects with contractors.
- Strong leadership, teamwork, and collaboration skills.
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
- Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.