Scientist of Chemical Development
Actively contribute to chemical development activities across a dynamic development and discovery space. The successful candidate will be flexible, have strong synthetic organic chemistry skills, and have experience in developing robust chemical processes supporting small molecule-based clinical programs.
- Responsible for phase appropriate synthetic route design and practical implementation of synthetic processes with the knowledge of when and how to address process liabilities and execute process improvements.
- Perform synthetic route scouting, identify scalable processes, scale up and transfer from laboratory to GMP manufacturing for small molecule APIs and intermediates.
- Identify process impurities, understand the origin of the impurities and implement process changes to improve process efficiency.
- Establish starting material, intermediate and drug substance control strategies in early development with a long-term vision of the commercial process.
- Work closely with Analytical Development during the development and implementation of phase appropriate drug substance analytical methods.
- Collaborate with drug substance CMO/CROs on process development and manufacturing operations, including technology transfer.
- Trouble-shoot manufacturing issues using both Company laboratories and CMO's plant resources.
- Review and provide critical input on master batch records, process investigations, and product dispositions for GMP activities.
- Act as person-in-plant during manufacturing campaigns.
- Interact with Formulation Development, Analytical Development, Medicinal Chemistry, Toxicology, and DMPK groups to ensure seamless collaboration among cross-function teams.
- Author technical reports, assessments and development summaries that will serve as a basis for CMC sections of regulatory documents.
- Up to 15% travel will be needed for scientific project management and monitoring of critical project activities.
- PhD in synthetic organic chemistry with 3+ years of experience, M.Sc. in synthetic organic chemistry with 5+ years of experience or bachelor's degree in synthetic organic chemistry with 10+ years of experience in the small molecule pharmaceutical industry.
- Hands-on laboratory experience with different stages of drug substance development.
- Experience working in a kilogram scale-up laboratory.
- Thorough understanding of the synthetic and analytical techniques necessary for proper process chemistry development, molecule characterization, and patent protection.
- Experience with Design of Experiments (DOE) and Quality by Design (QbD) principles.
- Extensive understanding of GMPs, GLPs, ICH guidelines, and industry best practices.
- Proven ability to work collaboratively on multiple projects and with numerous stakeholders in and outside of the Technical Operations group.
- Strong verbal and written communication and interpersonal skills.
Job Type: Direct Placement
Location: Brisbane, CA
Job ID: 19-09423
Date Updated: October 9, 2019