DIRECTOR OF CHEMICAL DEVELOPMENT (BRIS 2.136)

UNITY Biotechnology is seeking an exceptional and highly motivated individual to lead the Chemical Development team. Reporting to the VP of Technical Operations, the individual will drive 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 that will support a variety of small molecule-based clinical programs.

Responsibilities:

• Responsible for phase-appropriate synthetic route design and practical implementation of synthetic processes with the awareness of when to address process liabilities and execute process improvements.
• Establish drug substance control strategies in early development 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 and vendors.
• Ability to coordinate and collaborate with internal and external quality control, quality assurance, and regulatory organizations to resolve technical issues and deviations.
• Project leadership and management of multiple drug substance CMO activities and manufacturing operations for projects under development, including technology transfer.
• Provide critical input on master batch records, stability protocols, SOPs, process investigations, and product dispositions for GMP activities.
• Authorship of regulatory documents, including initial submissions, amendments, requests, and NDAs
• Invest in the department’s quality culture by maintaining and building an environment that is focused on continuous improvement and learning.
• Build appropriate risk management and life-cycle strategies for chemical development manufacturing.
• Partner with the Medicinal Chemistry team to provide smooth transitions of small molecules from Discovery to Development.
• Up to 10% travel may be needed for scientific project management and monitoring of critical project activities.

• PhD in synthetic organic chemistry, minimum of 10 years of experience in the small molecule pharmaceutical industry.
• Hands-on laboratory experience in various clinical stages of drug substance development.
• Chemical development experience with chiral molecules and chiral crystallizations preferred.
• Proven ability to work collaboratively on multiple projects with numerous stakeholders in and outside the Technical Operations team.
• Comprehensive understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization, and patent protection.
• Extensive knowledge of GMPs, GLPs, ICH guidelines, and industry best practices.
• Thorough understanding of Design of Experiments (DoE) and Quality by Design (QbD) principles.