Preclinical Laboratory, Operations, and Facilities Lead

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 Preclinical Laboratory, Operations, and Facilities Lead is responsible for the coordination and administration of AVROBIO’s Laboratory and internal non-GLP research activities in collaboration with AVROBIO’s researchers to support the discovery stage development programs for lentiviral-based gene therapies focusing on rare diseases, where a faulty gene results in a lack of an essential enzyme or protein. The successful candidate will work with the preclinical team by enabling AVROBIO’s Laboratory, in vitro and in vivo laboratory readiness, resource management, writing laboratory procedure’s, non-GLP preclinical study protocols and reports archival, data QC, and budget.

Research and Development
Key Responsibilities
  • Accountable for supplies and resources required for AVROBIO’s laboratory and satellite sites to support non-GLP preclinical studies and in vitro assays (negotiation & procurement)
  • Manage the budget for AVROBIO’s Laboratory and facility related expenses

·        Provide key operational support to the research & development team including vendor management and contracts management (creation of Statement of Work (SOWs) and Purchase Orders in collaboration with the legal and finance departments)

·        Oversee the management of all aspects of laboratory equipment, resources and supply planning and execution including procurement, installation, calibration, maintenance, employee training, and equipment alarm system and schedule maintenance with the lab operations team

  • Collaboratively write internal Laboratory Procedures’ supporting AVROBIO’s internal research programs and maintain the system
  • Collaboratively assist in writing internal non-GLP nonclinical study protocols and study reports as needed
  • Ensure that allin vitro assays laboratory data and non-GLP preclinical studies performed at satellite sites are maintained and archived. Implement and manage external facility for paper storage archival process
  • Continue implementation of biological inventory system (plasmid/vectors/cell lines) & coordinate sample management for non-GLP research​ in collaboration of the preclinical dev team

·        Manage electronic data collection methods and sample management and archiving, including electronic inventory system (ELN) compliance, procurement systems, and inventory systems

  • Works cross-functionally to support preclinical quality initiatives
  • Assure that routine fit for purpose testing of laboratory equipment is performed
  • Assure that routine raw material is used in laboratory meet research grade specification (for example cell line testing management)
  • Spearhead inspection readiness trainings and follow-ups
  • Onboarding new hires & ensuring proper Environmental Health and Safety (EH&S) program and maintain training ​records
  • Maintaining a safe work environment in compliance with all applicable environmental, health and safety regulations​
  • Ensure Proper Facilities’ permits are renewed and in place (rDNA permit, flammables, cryo, etc.)
  • Act as the Biosafety and chemical hygiene officer (BSO/CHO)
  • Laboratory & Facilities maintenance ​& expansion
  • Successfully work cross-functionally in a matrix environment
  • Oversees the laboratory operations team
Minimum Requirements/ Qualifications
  • B.S or M.S. in scientific field (Biology, Biotechnology, Veterinary Medicine)
  • 5+ years of experience working in preclinical research in an academic, pharmaceutical, biotech or contract research organizationExperience or knowledge as Biosafety Officer/Chemical Hygiene Officer 
  • Possess a good understanding of study techniques, problem solving skills, good planning, organizational and communication skills as well as excellent interpersonal skills
  • Familiarity with animal Laboratory management and / or animal studies in a research setting is essential
  • Project management or research experience
  • Process development and implementation experience
  • Demonstrated communication and organizational skills a must
  • Critical thinking, negotiation, leadership, and computer skills highly preferred
  • Knowledge of IDBS ELN and Inventory systems is a plus
  • Lab buildout/expansion experience is preferred
  • GLP or GMP knowledge is a plus

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