Manager, External Manufacturing

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Job Summary

The Manager, External Manufacturing will play a key role in the partnership and management of CMO activities. The role will help review and optimize assays over multiple CMOs. The Manager, External Manufacturing will also provide general oversight and management of CMOs.

Cambridge
Manufacturing
Key Responsibilities
  • Review and help develop clinical production records for both manufacturing and analytical assays with a focus on the assays.
  • Communicate priorities and escalate issues to External Manufacturing leadership.
  • Create and manage multiple timelines (assay transfer, pre-production activities, critical material usage etc.) with AVROBIO CMO partners.
  • Analyze production and QC data to help find root cause of issue and to support process improvements. 
  • Work with process development and QA to design experiments to correct process and QC issues and/or to improve performance. Includes change control generation, management, and closure
Minimum Requirements/ Qualifications
  • 5+ years of relatable industry experience required
  • Preferred technical ability and knowledge: Flow cytometry, Potency (biochemical), PCR based assays
  • High level of attention to detail
  • Action oriented and must have the ability to orchestrate and coordinate teams of internal and external stakeholders.
  • Must have ability to thrive in a small, collaborative, and growing organization.
  • Strong oral and written communications skills are required.
  • Must be able to interact effectively with all levels of the organization
  • Project management experience
  • Bachelor’s Degree required
About AVROBIO

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.

AVROBIO, Inc is an EEO employer