Senior Manager/Associate Director of Pharmaceutical Development
Unity Biotechnology is seeking an exceptional and highly motivated individual to join the Pharmaceutical Development group. Reporting to the VP of Technical Operations, the individual will lead pharmaceutical activities across a dynamic development and discovery space. The successful candidate will be flexible, have strong leadership skills, and have experience in pharmaceutical development beyond solid oral dosage.
- Develop phase appropriate small molecule sterile liquid, suspension, and lyophilized formulations for parental and pulmonary clinical administration.
- Develop small molecule topical formulations for clinical administration.
- Perform pre-formulations experiments in-house and work closely with Unity’s internal discovery organization to develop GLP appropriate formulations.
- Working closely with Unity’s head of manufacturing, help to evaluate and select pharmaceutical development and manufacturing CROs and CMOs. Monitor and troubleshoot on-going manufacturing and development activities.
- Review master batch records, stability, and development reports.
- Act as an SME on multidisciplinary project teams.
- Authorship of regulatory documents and technical reports.
- Development of immediate release and controlled release formulations.
- Alignment and understanding of phase appropriate analytical and quality requirements for GMP drug products.
- PhD in pharmaceutical sciences, chemical engineering, or chemistry with minimum of 8 years of pharmaceutical industry.
- Successful track record of developing clinical formulations. Commercial experience not necessary but desirable.
- Experience and first-hand use of common pharmaceutical and analytical equipment.
- Extensive understand of GMPs, GLPs, and industry best practices.
- Ability to work collaboratively on multiple projects and with numerous stakeholders in a fast-paced environment.
- Familiar with the overall drug development process outside of pharmaceutical development.
- Up to 25% travel.