Senior Manager/Associate Director, Formulation Development Group Research Associate, Immunohistochemistry and Analytical Histology
SCIENTIST / SR. SCIENTIST OF CHEMICAL DEVELOPMENT

BRIS 1.014

Unity Biotechnology is seeking an exceptional and highly motivated scientist to join the Chemical Development group. Reporting to the head of Chemical Development, the individual will 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 Unity’s 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.

REQUIREMENTS:

  • 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.

Please send resume and cover letter