Scientist of Chemical Development


Scientist, Chemical Development
Brisbane, CA 


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.

Responsibilities:
  • 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.
Qualifications:
  • 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 Details

Job Type: Direct Placement
Location: Brisbane, CA
Job ID: 19-09423
Date Updated: October 9, 2019