The Senior Director of Manufacturing will support manufacturing activities related to its ex-vivo gene therapy programs. The candidate is expected to have in-depth knowledge in the field of cell and gene therapy along with direct experience in current manufacturing processes and will work in a team setting to oversee multiple functions of CMOs working with AVROBIO. The candidate will be expected to review and evaluate both proposals and results submitted to AVROBIO from CMOs, covering research, technical transfer, development, analytics and clinical production of ex-vivo gene therapies. The candidate will also be expected to interact extensively with other internal teams such as R&D, Preclinical, Regulatory and Clinical to support their activities. This position reports to the Head of Operations.
- Coordinate and maintain oversight of multiple CMO programs as part of AVROBIO’s manufacturing team.
- Evaluate proposed timelines, proposals and processes from CMOs to ensure compliance with AVROBIO’s requirements.
- Develop plans for CMO activities such as technical transfer, drug product testing and
- Work cross functionally to participate in regulatory and clinical discussions internally and with CMOs as part of program planning.
- Analyze CMO output and results to determine decision-making required for next steps.
- Accurately report on status and planned outcomes.
- Work cross functionally with Finance to prepare and monitor budgets.
- Advanced Degree with 10 + years’ experience supporting manufacturing in the Pharmaceutical or Biotech industry.
- 5+ years of experience in the field of cell and gene therapy.
- In-depth experience in process development, tech transfer and GMP manufacturing.
- Proven ability to successfully manage multiple projects.
- Participate in external conferences to keep current with best practices.
- Ability to independently work through issues and challenges and innovative solutions.
- Excellent written and verbal communication skills.
- Proven success working as part of a team in a fast-paced environment.
- Experience interacting with contract development and manufacturing organizations.
- Previous experience monitoring budgets preferred.
- Ability to travel 10% both domestically and internationally required.
Click here for LinkedIn Easy Apply: Senior Director, Manufacturing – Gene Therapy
AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.