Senior Manager/Associate Director of Chemical Development & Drug Substance Manufacturing

Unity Biotechnology is seeking an exceptional and highly motivated individual to join the Chemical Development group. Reporting to the VP of Technical Operations, the individual will lead chemical development activities across a dynamic development and discovery space. The successful candidate will be flexible, have strong leadership skills, and have experience in developing robust chemical processes supporting small molecule-based clinical programs.

Responsibilities:

  • Responsible for phase appropriate synthetic route design, practical implementation of synthetic processes and controls for regulatory starting materials, intermediates, and drug substances.
  • Establish drug substance early development control strategies with a long-term vision of the commercial process.
  • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs.
  • Work closely with other senior members of the Technical Operations group to help evaluate and select pharmaceutical development and manufacturing CROs and CMOs.
  • Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations.
  • Project leadership and management of multiple drug substance CMO/CRO activities and manufacturing operations for projects under development including technology transfer.
  • Review master batch records, stability, and development reports for GMP activities.
  • Authorship of regulatory documents and technical reports.
  • Build appropriate risk management strategies for chemical development manufacturing.
  • Up to 20% travel will be needed for scientific project management and monitoring of critical project activities.

Qualifications:

  • Ph.D in synthetic organic chemistry, minimum of 8 years of experience in the small molecule pharmaceutical industry.
  • Hands-on laboratory experience with different stages of drug substance development.
  • Chemical development experience with chiral molecules and chiral crystallizations preferred.
  • Ability to work collaboratively on multiple projects and with numerous stakeholders in and outside of the Technical Operations group.
  • Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization, and patent protection.
  • Extensive understand of GMPs, GLPs, ICH guidelines, and industry best practices.
  • Experience with Design of Experiments (DOE) and Quality by Design (QbD) principles.

To apply please send resume and cover letter to careers@unitybiotechnology.com