ASSOCIATE DIRECTOR/DIRECTOR OF FORMULATION DEVELOPMENT (BRIS 2.128)
UNITY Biotechnology is seeking an exceptional and highly motivated individual to lead the Formulation Development group. Reporting to the VP of Technical Operations, the individual will lead formulation activities across a dynamic development and discovery space, develop reliable & cost-effective outsourcing strategies for drug product development from concept to CTM supply. The successful candidate will be flexible, have strong leadership skills, and is well versed in formulation design and pharmaceutical development for both small molecules and biologics.
- Develop phase appropriate sterile liquid, suspension, and lyophilized formulations for parental and ocular clinical administration.
- Perform pre-formulations experiments in-house and work closely with UNITY’s internal discovery organization to develop appropriate GLP formulations for IND enabling tox studies.
- Work closely with other senior members of the Technical Operations group to evaluate and select pharmaceutical development and manufacturing CROs and CMOs that are well aligned with UNITY’s development strategy.
- Project leadership and management of multiple drug product CMOs/CROs, including technology transfers and person-in-plant as part of outsourcing oversight,
- Serve as relationship manager for drug product CMOs/CROs to insure appropriate resources dedicated to UNITY projects on an on-going basis.
- Lead contract negotiation for drug product development activities at CMOs/CROs to insure cost projection well aligned with UNITY’s budgetary estimates.
- Serve as the Operations group representative on internal multidisciplinary project teams.
- Review and approve master batch records, stability, and development reports for GMP activities.
- Authorship of regulatory documents, including IND and IND amendment and technical reports.
- Development of immediate release and controlled release PLGA formulations and work closely with DMPK in evaluating these formulations in appropriate animal models
- Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations.
- Alignment and understanding of phase appropriate analytical and quality requirements for GMP drug products.
- Up to 15% travel to foreign and domestics contractors for scientific project management and monitoring of critical project activities.
- Ph.D. in pharmaceutical sciences, chemical engineering, or chemistry with a minimum of 12 years of pharmaceutical industry.
- Successful track record of developing clinical formulations. Commercial experience not necessary but desirable.
- Experience with and first-hand use of common pharmaceutical and analytical equipment.
- Extensive understand of GMPs, GLPs, ICH guidelines, and industry best practices.
- Experience with lifecycle product management.
- Strong verbal communication, written communication, and organizational skills.
- Ability to work collaboratively on multiple projects with numerous stakeholders in and outside of the Technical Operations group.
- Familiar with the overall drug development process beyond pharmaceutical development.